<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813199</url>
  </required_header>
  <id_info>
    <org_study_id>ABX464-301</org_study_id>
    <nct_id>NCT03813199</nct_id>
  </id_info>
  <brief_title>Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis</brief_title>
  <official_title>Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfα, or Intolerance to Anti-Tnfα</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abivax S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abivax S.A.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of&#xD;
      ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to&#xD;
      severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one&#xD;
      or more anti- tumor necrosis factor alpha (TNFα) therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, multicenter study. The study will&#xD;
      consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase.&#xD;
&#xD;
      Approximately 60 participants with active Rheumatoid Arthritis will be randomly assigned to&#xD;
      receive placebo, 50mg ABX464 or 100mg ABX464 during the treatment phase.&#xD;
&#xD;
      The maximum period of active treatment will be 12 weeks. The maximum duration of study&#xD;
      participation will be 17 weeks.&#xD;
&#xD;
      Participant safety will be monitored throughout the study. In addition, several experimental&#xD;
      and clinical endpoints will be assessed to obtain information on preliminary efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2019</start_date>
  <completion_date type="Actual">April 27, 2021</completion_date>
  <primary_completion_date type="Actual">April 27, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo</measure>
    <time_frame>through study completion, an average of 15 weeks</time_frame>
    <description>TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving ACR20 Response</measure>
    <time_frame>at Week 12</time_frame>
    <description>The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving ACR20/50/70 Response</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-reactive Protein (CRP)</measure>
    <time_frame>Week 12</time_frame>
    <description>Change from baseline in C-reactive protein (CRP) at Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving DAS28-CRP Response</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]</measure>
    <time_frame>Week 12</time_frame>
    <description>The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA).&#xD;
DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score &gt;5.1 indicates high disease activity, a DAS28 score &lt;3.2 indicates low disease activity, and a DAS28 score &lt;2.6 indicates clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>Week 12</time_frame>
    <description>Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR &lt; 2.6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA).&#xD;
DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score &gt;5.1 indicates high disease activity, a DAS28 score &lt;3.2 indicates low disease activity, and a DAS28 score &lt;2.6 indicates clinical remission.&#xD;
change from baseline at weeks 12: the bigger negative score shows a bigger improvment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index Score (SDAI)</measure>
    <time_frame>Week 12</time_frame>
    <description>SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).&#xD;
SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score &gt;11 to 26 included. A high activity is defined by a SDAI score &gt;26. Change from Baseline: the higher negative number shows a bigger improvment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index Score (CDAI)</measure>
    <time_frame>Week 12</time_frame>
    <description>CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).&#xD;
CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score &gt;10 to 22 included. A high activity is defined by a CDAI score &gt;22. Change from Baseline: the higher negative number shows a bigger improvment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving Low Disease Activity (LDA)</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR &lt;=3.2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving Clinical Disease Activity (CDAI) Remission</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission</measure>
    <time_frame>Week 12</time_frame>
    <description>The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tender/Painful Joint Count (TJC28)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Swollen Joint Count (SJC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Visual Analog Scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Global Assessment of Disease (PtGA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Investigator Global Assessment of Disease (PrGA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2.&#xD;
The 8 scores of the 8 sections are summed and divided by the number of section answered.&#xD;
This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>ABX464 50mg + methotrexate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABX464 100mg + methotrexate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + methotrexate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 50mg</intervention_name>
    <description>ABX464 is a new anti-inflammatory drug</description>
    <arm_group_label>ABX464 50mg + methotrexate</arm_group_label>
    <other_name>obefazimod 50mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>placebo matching with ABX464</description>
    <arm_group_label>ABX464 50mg + methotrexate</arm_group_label>
    <arm_group_label>Placebo + methotrexate</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 100mg</intervention_name>
    <description>ABX464 is a new anti-inflammatory drug</description>
    <arm_group_label>ABX464 100mg + methotrexate</arm_group_label>
    <other_name>obefazimod 100mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
    <arm_group_label>ABX464 100mg + methotrexate</arm_group_label>
    <arm_group_label>ABX464 50mg + methotrexate</arm_group_label>
    <arm_group_label>Placebo + methotrexate</arm_group_label>
    <other_name>MTX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis,&#xD;
             for at least 12 weeks, according to the revised 2010 American College of Rheumatology-&#xD;
             European League Against Rheumatism (ACR-EULAR) classification criteria, including at&#xD;
             least one positive criteria among the following: Rheumatoid Factor (RF),&#xD;
             Anti-Citrullinated Peptide Antibody (ACPA) or bone erosion;&#xD;
&#xD;
          -  Swollen joint count (SJC) of ≥ 4 (28-joint count) and tender joint count (TJC) ≥4&#xD;
             (28-joint count) at screening;&#xD;
&#xD;
          -  Patient with a moderate to severe disease activity score Disease Activity Score (28&#xD;
             joints) C-Reactive Protein [DAS28 CRP] ≥ 3.2 and C-reactive Protein (CRP) ≥ 5 mg/L (≥&#xD;
             4.76 nmol)/L) at screening;&#xD;
&#xD;
          -  Patient who had an inadequate response (IR), or failed either methotrexate (MTX)&#xD;
             or/and anti- Tumor Necrosis Factor alpha (TNFα) therapy (both administered for at&#xD;
             least 12 weeks before IR) or were intolerant to anti- TNFα therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a known positive anti-double stranded deoxyribonucleic acid (DNA&#xD;
             [anti-dsDNA]) and confirmed diagnosis of systemic lupus erythematosus (SLE);&#xD;
&#xD;
          -  Patient with known active infections at screening such as CytoMegaloVirus (CMV),&#xD;
             herpes virus and/or recent infectious hospitalization;&#xD;
&#xD;
          -  Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic,&#xD;
             pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable&#xD;
             Central Nervous System (CNS) pathology such as seizure disorder, angina or cardiac&#xD;
             arrhythmias, active malignancy or any other clinically significant medical problems as&#xD;
             determined by physical examination and/or laboratory screening tests and/or medical&#xD;
             history;&#xD;
&#xD;
          -  Acute, chronic or history of immunodeficiency or other autoimmune disease;&#xD;
&#xD;
          -  Patient previously treated with any non-anti-TNF biological Disease-Modifying&#xD;
             AntiRheumatic Drugs (bDMARDs), and targeted DMARDs (tDMARDS) prior to baseline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul GINESTE, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Abivax S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Jan Palfijn</name>
      <address>
        <city>Merksem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Tomayerova nemocnice</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologicky ustav</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest - Hôpital Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHR Mulhouse Sud-Alsace</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice - Hôpital Pasteur</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'Orléans</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Hôpital Salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Tours - Hôpital Trousseau</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complex Medical Centre - Déli Klinika</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary Ltd.</name>
      <address>
        <city>Miskolc</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMed Rehabilitációs és Diagnosztikai Központ</name>
      <address>
        <city>Székesfehérvár</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinicMed Daniluk, Nowak Sp. J.</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pratia MCM</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zespół Poradni Specjalistycznych REUMED</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Lecznica MAK-MED S.C.</name>
      <address>
        <city>Nadarzyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medyczne Centrum Hetmańska</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Geriatrics</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RHEUMA MEDICUS Zakład Opieki Zdrowotnej</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Hungary</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <results_first_submitted>February 3, 2022</results_first_submitted>
  <results_first_submitted_qc>February 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2022</results_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03813199/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03813199/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ABX464 50mg + Methotrexate</title>
          <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="P2">
          <title>ABX464 100mg + Methotrexate</title>
          <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="P3">
          <title>Placebo + Methotrexate</title>
          <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ABX464 50mg + Methotrexate</title>
          <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="B2">
          <title>ABX464 100mg + Methotrexate</title>
          <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="B3">
          <title>Placebo + Methotrexate</title>
          <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="11.4"/>
                    <measurement group_id="B2" value="54.4" spread="10.6"/>
                    <measurement group_id="B3" value="58.6" spread="11.0"/>
                    <measurement group_id="B4" value="57.0" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo</title>
        <description>TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment</description>
        <time_frame>through study completion, an average of 15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo</title>
          <description>TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving ACR20 Response</title>
        <description>The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response.</description>
        <time_frame>at Week 12</time_frame>
        <population>Intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving ACR20 Response</title>
          <description>The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response.</description>
          <population>Intent to treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving ACR20/50/70 Response</title>
        <description>Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving ACR20/50/70 Response</title>
          <description>Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.</description>
          <population>Intent to Treat Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR20 response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50 response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-reactive Protein (CRP)</title>
        <description>Change from baseline in C-reactive protein (CRP) at Week 12</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-reactive Protein (CRP)</title>
          <description>Change from baseline in C-reactive protein (CRP) at Week 12</description>
          <population>Intent to Treat</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.31" spread="28.83"/>
                    <measurement group_id="O2" value="0.62" spread="4.89"/>
                    <measurement group_id="O3" value="-0.65" spread="18.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving DAS28-CRP Response</title>
        <description>Number of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving DAS28-CRP Response</title>
          <description>Number of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response</description>
          <population>Intent to Treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]</title>
        <description>The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA).&#xD;
DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score &gt;5.1 indicates high disease activity, a DAS28 score &lt;3.2 indicates low disease activity, and a DAS28 score &lt;2.6 indicates clinical remission.</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]</title>
          <description>The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA).&#xD;
DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score &gt;5.1 indicates high disease activity, a DAS28 score &lt;3.2 indicates low disease activity, and a DAS28 score &lt;2.6 indicates clinical remission.</description>
          <population>Intent to Treat population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="1.45"/>
                    <measurement group_id="O2" value="-0.72" spread="1.13"/>
                    <measurement group_id="O3" value="-0.60" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Sedimentation Rate (ESR)</title>
        <description>Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Sedimentation Rate (ESR)</title>
          <description>Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12</description>
          <population>Intent to Treat population</population>
          <units>mm/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="19.3"/>
                    <measurement group_id="O2" value="-0.3" spread="6.8"/>
                    <measurement group_id="O3" value="-2.7" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission</title>
        <description>Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR &lt; 2.6</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission</title>
          <description>Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR &lt; 2.6</description>
          <population>Intent to Treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)</title>
        <description>The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA).&#xD;
DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score &gt;5.1 indicates high disease activity, a DAS28 score &lt;3.2 indicates low disease activity, and a DAS28 score &lt;2.6 indicates clinical remission.&#xD;
change from baseline at weeks 12: the bigger negative score shows a bigger improvment</description>
        <time_frame>12 weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)</title>
          <description>The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA).&#xD;
DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score &gt;5.1 indicates high disease activity, a DAS28 score &lt;3.2 indicates low disease activity, and a DAS28 score &lt;2.6 indicates clinical remission.&#xD;
change from baseline at weeks 12: the bigger negative score shows a bigger improvment</description>
          <population>Intent to Treat</population>
          <units>mm/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="1.39"/>
                    <measurement group_id="O2" value="-0.74" spread="1.11"/>
                    <measurement group_id="O3" value="-0.59" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index Score (SDAI)</title>
        <description>SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).&#xD;
SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score &gt;11 to 26 included. A high activity is defined by a SDAI score &gt;26. Change from Baseline: the higher negative number shows a bigger improvment</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index Score (SDAI)</title>
          <description>SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).&#xD;
SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score &gt;11 to 26 included. A high activity is defined by a SDAI score &gt;26. Change from Baseline: the higher negative number shows a bigger improvment</description>
          <population>Intent to Treat population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.21" spread="33.27"/>
                    <measurement group_id="O2" value="-9.37" spread="14.44"/>
                    <measurement group_id="O3" value="-7.58" spread="22.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index Score (CDAI)</title>
        <description>CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).&#xD;
CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score &gt;10 to 22 included. A high activity is defined by a CDAI score &gt;22. Change from Baseline: the higher negative number shows a bigger improvment</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index Score (CDAI)</title>
          <description>CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).&#xD;
CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score &gt;10 to 22 included. A high activity is defined by a CDAI score &gt;22. Change from Baseline: the higher negative number shows a bigger improvment</description>
          <population>Intent to Treat population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.89" spread="13.29"/>
                    <measurement group_id="O2" value="-9.99" spread="15.85"/>
                    <measurement group_id="O3" value="-6.93" spread="10.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving Low Disease Activity (LDA)</title>
        <description>Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR &lt;=3.2</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving Low Disease Activity (LDA)</title>
          <description>Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR &lt;=3.2</description>
          <population>Intent to Treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission</title>
        <description>Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission</title>
          <description>Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3</description>
          <population>Intent to Treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving Clinical Disease Activity (CDAI) Remission</title>
        <description>Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving Clinical Disease Activity (CDAI) Remission</title>
          <description>Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8</description>
          <population>Intent to Treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission</title>
        <description>The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1</description>
        <time_frame>Week 12</time_frame>
        <population>Intent to Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission</title>
          <description>The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1</description>
          <population>Intent to Treat population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tender/Painful Joint Count (TJC28)</title>
        <description>Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is</description>
        <time_frame>12 weeks</time_frame>
        <population>intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tender/Painful Joint Count (TJC28)</title>
          <description>Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is</description>
          <population>intent to treat</population>
          <units>joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="6.4"/>
                    <measurement group_id="O2" value="-4.1" spread="6.6"/>
                    <measurement group_id="O3" value="-2.9" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Swollen Joint Count (SJC)</title>
        <description>Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is</description>
        <time_frame>12 weeks</time_frame>
        <population>Intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Swollen Joint Count (SJC)</title>
          <description>Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is</description>
          <population>Intent to treat</population>
          <units>joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="4.2"/>
                    <measurement group_id="O2" value="-3.2" spread="5.3"/>
                    <measurement group_id="O3" value="-2.1" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pain Visual Analog Scale</title>
        <description>Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment</description>
        <time_frame>12 weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pain Visual Analog Scale</title>
          <description>Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment</description>
          <population>Intent to Treat</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.63" spread="2.43"/>
                    <measurement group_id="O2" value="-0.89" spread="1.97"/>
                    <measurement group_id="O3" value="-0.78" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Global Assessment of Disease (PtGA)</title>
        <description>Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment</description>
        <time_frame>12 weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Global Assessment of Disease (PtGA)</title>
          <description>Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment</description>
          <population>Intent to Treat</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.44" spread="1.92"/>
                    <measurement group_id="O2" value="-0.89" spread="1.93"/>
                    <measurement group_id="O3" value="-0.36" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Investigator Global Assessment of Disease (PrGA)</title>
        <description>Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement</description>
        <time_frame>12 weeks</time_frame>
        <population>Intent to treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Investigator Global Assessment of Disease (PrGA)</title>
          <description>Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement</description>
          <population>Intent to treat</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.26" spread="2.7"/>
                    <measurement group_id="O2" value="-1.89" spread="2.95"/>
                    <measurement group_id="O3" value="-1.63" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)</title>
        <description>Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2.&#xD;
The 8 scores of the 8 sections are summed and divided by the number of section answered.&#xD;
This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment</description>
        <time_frame>12 weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 50mg + Methotrexate</title>
            <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O2">
            <title>ABX464 100mg + Methotrexate</title>
            <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
          <group group_id="O3">
            <title>Placebo + Methotrexate</title>
            <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)</title>
          <description>Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2.&#xD;
The 8 scores of the 8 sections are summed and divided by the number of section answered.&#xD;
This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment</description>
          <population>Intent to Treat</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4345" spread="0.6182"/>
                    <measurement group_id="O2" value="-0.1053" spread="0.3443"/>
                    <measurement group_id="O3" value="-0.1813" spread="0.4824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ABX464 50mg + Methotrexate</title>
          <description>Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 50mg: ABX464 is a new anti-inflammatory drug&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="E2">
          <title>ABX464 100mg + Methotrexate</title>
          <description>Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks&#xD;
+ methotrexate&#xD;
ABX464 100mg: ABX464 is a new anti-inflammatory drug&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
        <group group_id="E3">
          <title>Placebo + Methotrexate</title>
          <description>Participants will receive two capsules of matching placebo once daily for 12 weeks&#xD;
+ methotrexate&#xD;
Matching Placebo: placebo matching with ABX464&#xD;
Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <description>atrial fibrillation reactive to hypokalemia secondary to diarrhea in the context of study drug treatment</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E2" events="10" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="19" subjects_affected="8" subjects_at_risk="21"/>
                <counts group_id="E2" events="16" subjects_affected="10" subjects_at_risk="19"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President Clinical Operations</name_or_title>
      <organization>Abivax</organization>
      <phone>01 53 83 08 41</phone>
      <email>paul.gineste@abivax.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813199
org study id: ABX464-301
nct id: NCT03813199
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of
      ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to
      severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one
      or more anti- tumor necrosis factor alpha (TNFα) therapies.
This is a randomized, double-blind, placebo-controlled, multicenter study. The study will
      consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase.

      Approximately 60 participants with active Rheumatoid Arthritis will be randomly assigned to
      receive placebo, 50mg ABX464 or 100mg ABX464 during the treatment phase.

      The maximum period of active treatment will be 12 weeks. The maximum duration of study
      participation will be 17 weeks.

      Participant safety will be monitored throughout the study. In addition, several experimental
      and clinical endpoints will be assessed to obtain information on preliminary efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo
time frame: through study completion, an average of 15 weeks
description: TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment
measure: Number of Patients Achieving ACR20 Response
time frame: at Week 12
description: The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response.
measure: Number of Patients Achieving ACR20/50/70 Response
time frame: Week 12
description: Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.
measure: Change From Baseline in C-reactive Protein (CRP)
time frame: Week 12
description: Change from baseline in C-reactive protein (CRP) at Week 12
measure: Number of Patients Achieving DAS28-CRP Response
time frame: Week 12
description: Number of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response
measure: Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]
time frame: Week 12
description: The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA).
DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
time frame: Week 12
description: Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12
measure: Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission
time frame: Week 12
description: Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR < 2.6
measure: Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)
time frame: 12 weeks
description: The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA).
DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
change from baseline at weeks 12: the bigger negative score shows a bigger improvment
measure: Change From Baseline in Simplified Disease Activity Index Score (SDAI)
time frame: Week 12
description: SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).
SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score >11 to 26 included. A high activity is defined by a SDAI score >26. Change from Baseline: the higher negative number shows a bigger improvment
measure: Change From Baseline in Clinical Disease Activity Index Score (CDAI)
time frame: Week 12
description: CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).
CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score >10 to 22 included. A high activity is defined by a CDAI score >22. Change from Baseline: the higher negative number shows a bigger improvment
measure: Number of Patients Achieving Low Disease Activity (LDA)
time frame: Week 12
description: Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2
measure: Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission
time frame: Week 12
description: Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3
measure: Number of Patients Achieving Clinical Disease Activity (CDAI) Remission
time frame: Week 12
description: Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8
measure: Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission
time frame: Week 12
description: The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1
measure: Change From Baseline in Tender/Painful Joint Count (TJC28)
time frame: 12 weeks
description: Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is
measure: Change From Baseline in Swollen Joint Count (SJC)
time frame: 12 weeks
description: Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is
measure: Change From Baseline in Pain Visual Analog Scale
time frame: 12 weeks
description: Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment
measure: Change From Baseline in Patient Global Assessment of Disease (PtGA)
time frame: 12 weeks
description: Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment
measure: Change From Baseline in Investigator Global Assessment of Disease (PrGA)
time frame: 12 weeks
description: Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
time frame: 12 weeks
description: Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2.
The 8 scores of the 8 sections are summed and divided by the number of section answered.
This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment
arm group label: ABX464 50mg + methotrexate
arm group type: Experimental
description: Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks
+ methotrexate
arm group label: ABX464 100mg + methotrexate
arm group type: Experimental
description: Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks
+ methotrexate
arm group label: Placebo + methotrexate
arm group type: Placebo Comparator
description: Participants will receive two capsules of matching placebo once daily for 12 weeks
+ methotrexate
intervention type: Drug
intervention name: ABX464 50mg
description: ABX464 is a new anti-inflammatory drug
arm group label: ABX464 50mg + methotrexate
other name: obefazimod 50mg
intervention type: Drug
intervention name: Matching Placebo
description: placebo matching with ABX464
arm group label: ABX464 50mg + methotrexate
arm group label: Placebo + methotrexate
other name: Placebo
intervention type: Drug
intervention name: ABX464 100mg
description: ABX464 is a new anti-inflammatory drug
arm group label: ABX464 100mg + methotrexate
other name: obefazimod 100mg
intervention type: Drug
intervention name: Methotrexate
description: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
arm group label: ABX464 100mg + methotrexate
arm group label: ABX464 50mg + methotrexate
arm group label: Placebo + methotrexate
other name: MTX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Paul GINESTE, PharmD
role: Study Director
affiliation: Abivax S.A.
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country: Belgium
country: Czechia
country: France
country: Hungary
country: Poland
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Methotrexate
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 