<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/NCT03797872</url>
  </required_header>
  <id_info>
    <org_study_id>18/SC/0261</org_study_id>
    <nct_id>NCT03797872</nct_id>
  </id_info>
  <brief_title>Psoriatic Oligoarthritis Intervention With Symptomatic thErapy</brief_title>
  <acronym>POISE</acronym>
  <official_title>Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      POISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or&#xD;
      TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low&#xD;
      impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act&#xD;
      as the control group. Arm 2 will receive local steroid injections to active joints and will&#xD;
      be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is&#xD;
      defined by standard practice in these PsA clinics following current international&#xD;
      recommendations and National requirements for the prescription of biologic therapy. Whilst&#xD;
      physician discretion is used, most commonly Initial therapy will be with methotrexate alone&#xD;
      (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is&#xD;
      contraindicated. In cases of non-response or intolerance to methotrexate, participants will&#xD;
      have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to&#xD;
      at the discretion of the rheumatologist. In cases of failure of two DMARDs, treatment can be&#xD;
      escalated to biologic therapy as per National Institute for Health and Clinical Excellence&#xD;
      (NICE) recommendations usually with a TNF inhibitor as first line. If the requisite disease&#xD;
      activity is not met or if there are contraindications to biologics, alternative DMARD&#xD;
      combinations will be used. Further details are available in the PsA clinic treatment protocol&#xD;
      which is Appendix D in the MONITOR-PsA protocol.&#xD;
&#xD;
      Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with&#xD;
      disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to&#xD;
      affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be&#xD;
      allowed as concomitant medication as indicated for individuals. Local glucocorticoid&#xD;
      injections will include injections with methylprednisolone or triamcinolone. All active&#xD;
      joints will be treated with glucocorticoid injections. Glucocorticoid injections can be&#xD;
      either be given as an intra-articular injection to an inflamed joint or as an intra-muscular&#xD;
      injection if multiple joints are involved. If any joint requires more than 2 local injections&#xD;
      of glucocorticoid within a 6 month period, then the patient is deemed to have failed&#xD;
      symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per&#xD;
      usual care (in most cases with DMARD therapy). If Participants require DMARD therapy, they&#xD;
      will be offered rescue therapy as per usual clinical care but will be asked to continue with&#xD;
      data collection for the trial. This is to ensure that sufficient data is collected for the&#xD;
      trial but risks in delaying treatment to the individual are mitigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Actual">July 16, 2020</completion_date>
  <primary_completion_date type="Actual">July 16, 2020</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded assessor will perform clinical evaluations</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study</measure>
    <time_frame>48 weeks</time_frame>
    <description>To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psoriatic Arthritis Disease Activity Score (PASDAS)</measure>
    <time_frame>48 weeks</time_frame>
    <description>A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as &lt;3.2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound Score of Synovitis</measure>
    <time_frame>0 weeks</time_frame>
    <description>A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound Score of Enthesitis</measure>
    <time_frame>0 weeks</time_frame>
    <description>A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local/IM steroid injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Methotrexate up to 25mg/week as tolerated po or sc</description>
    <arm_group_label>Standard care</arm_group_label>
    <other_name>methotrexate sodium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfasalazine</intervention_name>
    <description>Sulfasalazine up to 3g daily po</description>
    <arm_group_label>Standard care</arm_group_label>
    <other_name>sulfasalazine pill</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leflunomide</intervention_name>
    <description>Leflunomide 10-20mg daily po</description>
    <arm_group_label>Standard care</arm_group_label>
    <other_name>leflunomide pill</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>For IA or IM injection 20-120mg</description>
    <arm_group_label>Local/IM steroid injections</arm_group_label>
    <other_name>methylprednisolone acetate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone</intervention_name>
    <description>For IA or IM injection 20-120mg</description>
    <arm_group_label>Local/IM steroid injections</arm_group_label>
    <other_name>triamcinolone acetonide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached&#xD;
             for alternate interventional therapies.&#xD;
&#xD;
          -  Participants with mild disease as defined by:&#xD;
&#xD;
               -  Oligoarticular disease with &lt;5 active joints at baseline assessment.&#xD;
&#xD;
               -  Low disease activity as defined by a PsA disease activity score (PASDAS) ≤3.2.&#xD;
&#xD;
               -  Low impact of disease as defined a PsA impact of disease (PSAID) ≤4.&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             trial.&#xD;
&#xD;
          -  Male or female.&#xD;
&#xD;
          -  Aged 18 years or above.&#xD;
&#xD;
          -  Female Participants of child bearing potential and male Participants whose partner is&#xD;
             of child bearing potential must be willing to ensure that they or their partner use&#xD;
             effective contraception (defined as true abstinence, oral contraceptives, implants,&#xD;
             intrauterine device, barrier method with spermicide, or surgical sterilization) during&#xD;
             the trial and for 3 months thereafter if receiving DMARD therapy (excluding&#xD;
             sulfasalazine).&#xD;
&#xD;
          -  Participant has clinically acceptable laboratory results within 6 weeks of enrolment:&#xD;
&#xD;
               -  Haemoglobin count &gt; 8.5 g/dL&#xD;
&#xD;
               -  White blood count (WBC) &gt; 3.5 x 109/L&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &gt; 1.5 x 109/L&#xD;
&#xD;
               -  Platelet count &gt; 100 x 109/L&#xD;
&#xD;
               -  ALT and alkaline phosphatase levels &lt;3 x upper limit of normal&#xD;
&#xD;
          -  In the Investigator's opinion, is able and willing to comply with all trial&#xD;
             requirements.&#xD;
&#xD;
          -  Willing to allow his or her GP and consultant, if appropriate, to be notified of&#xD;
             participation in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ≥1 poor prognostic factors for psoriatic arthritis, from&#xD;
&#xD;
               -  raised C reactive protein (CRP) defined as &gt; 4g/dl for standard non-hsCRP&#xD;
&#xD;
               -  radiographic damage defined as the presence of ≥ 1 erosion on plain radiographs&#xD;
                  of the hands and feet&#xD;
&#xD;
               -  health assessment questionnaire (HAQ) score &gt; 1&#xD;
&#xD;
          -  Contraindications to non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Previous treatment for articular disease with synthetic DMARDs (including&#xD;
             methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including TNF, IL12/23&#xD;
             or IL17 inhibitor therapies) or targeted synthetic DMARDs (PDE4 of JAK inhibitor&#xD;
             therapies).&#xD;
&#xD;
          -  Female patient who is pregnant, breast feeding or planning pregnancy during the course&#xD;
             of the trial.&#xD;
&#xD;
          -  Significant renal or hepatic impairment.&#xD;
&#xD;
          -  Scheduled elective surgery or other procedures requiring general anaesthesia during&#xD;
             the trial.&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the patients at risk because of participation in the trial, or may&#xD;
             influence the result of the trial, or the participant's ability to participate in the&#xD;
             trial.&#xD;
&#xD;
          -  Patients who have participated in another research trial involving an investigational&#xD;
             product in the past 12 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <results_first_submitted>February 15, 2021</results_first_submitted>
  <results_first_submitted_qc>May 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2021</results_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2021</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, Psoriatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulfasalazine</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
    <mesh_term>Leflunomide</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03797872/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The POISE trial opened on 17 April 2019 in Oxford and 19 September 2019 in Bath.&#xD;
The study remained open until 16 July 2020 as planned.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
        </group>
        <group group_id="P2">
          <title>Local/IM Steroid Injections</title>
          <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Only one participant was included</population>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
        </group>
        <group group_id="B2">
          <title>Local/IM Steroid Injections</title>
          <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
        </group>
        <group group_id="B3">
          <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="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study</title>
        <description>To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).</description>
        <time_frame>48 weeks</time_frame>
        <population>All participants included</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
          </group>
          <group group_id="O2">
            <title>Local/IM Steroid Injections</title>
            <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study</title>
          <description>To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).</description>
          <population>All participants included</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriatic Arthritis Disease Activity Score (PASDAS)</title>
        <description>A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as &lt;3.2.</description>
        <time_frame>48 weeks</time_frame>
        <population>Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
          </group>
          <group group_id="O2">
            <title>Local/IM Steroid Injections</title>
            <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriatic Arthritis Disease Activity Score (PASDAS)</title>
          <description>A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as &lt;3.2.</description>
          <population>Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ultrasound Score of Synovitis</title>
        <description>A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276</description>
        <time_frame>0 weeks</time_frame>
        <population>Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
          </group>
          <group group_id="O2">
            <title>Local/IM Steroid Injections</title>
            <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound Score of Synovitis</title>
          <description>A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276</description>
          <population>Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ultrasound Score of Enthesitis</title>
        <description>A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30</description>
        <time_frame>0 weeks</time_frame>
        <population>Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
          </group>
          <group group_id="O2">
            <title>Local/IM Steroid Injections</title>
            <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound Score of Enthesitis</title>
          <description>A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30</description>
          <population>Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 week study</time_frame>
      <desc>48 week study</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.&#xD;
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc&#xD;
Sulfasalazine: Sulfasalazine up to 3g daily po&#xD;
Leflunomide: Leflunomide 10-20mg daily po</description>
        </group>
        <group group_id="E2">
          <title>Local/IM Steroid Injections</title>
          <description>Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).&#xD;
Methylprednisolone: For IA or IM injection 20-120mg&#xD;
Triamcinolone: For IA or IM injection 20-120mg</description>
        </group>
      </group_list>
      <serious_events>
        <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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <limitations_and_caveats>Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Professor Laura Coates</name_or_title>
      <organization>University of Oxford</organization>
      <phone>+447870257823</phone>
      <email>laura.coates@ndorms.ox.ac.uk</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/NCT03797872
org study id: 18/SC/0261
nct id: NCT03797872
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
POISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or
      TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low
      impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act
      as the control group. Arm 2 will receive local steroid injections to active joints and will
      be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only
Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is
      defined by standard practice in these PsA clinics following current international
      recommendations and National requirements for the prescription of biologic therapy. Whilst
      physician discretion is used, most commonly Initial therapy will be with methotrexate alone
      (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is
      contraindicated. In cases of non-response or intolerance to methotrexate, participants will
      have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to
      at the discretion of the rheumatologist. In cases of failure of two DMARDs, treatment can be
      escalated to biologic therapy as per National Institute for Health and Clinical Excellence
      (NICE) recommendations usually with a TNF inhibitor as first line. If the requisite disease
      activity is not met or if there are contraindications to biologics, alternative DMARD
      combinations will be used. Further details are available in the PsA clinic treatment protocol
      which is Appendix D in the MONITOR-PsA protocol.

      Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with
      disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to
      affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be
      allowed as concomitant medication as indicated for individuals. Local glucocorticoid
      injections will include injections with methylprednisolone or triamcinolone. All active
      joints will be treated with glucocorticoid injections. Glucocorticoid injections can be
      either be given as an intra-articular injection to an inflamed joint or as an intra-muscular
      injection if multiple joints are involved. If any joint requires more than 2 local injections
      of glucocorticoid within a 6 month period, then the patient is deemed to have failed
      symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per
      usual care (in most cases with DMARD therapy). If Participants require DMARD therapy, they
      will be offered rescue therapy as per usual clinical care but will be asked to continue with
      data collection for the trial. This is to ensure that sufficient data is collected for the
      trial but risks in delaying treatment to the individual are mitigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded assessor will perform clinical evaluations
measure: Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
time frame: 48 weeks
description: To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).
measure: Psoriatic Arthritis Disease Activity Score (PASDAS)
time frame: 48 weeks
description: A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2.
measure: Ultrasound Score of Synovitis
time frame: 0 weeks
description: A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276
measure: Ultrasound Score of Enthesitis
time frame: 0 weeks
description: A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30
arm group label: Standard care
arm group type: Active Comparator
description: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
arm group label: Local/IM steroid injections
arm group type: Experimental
description: Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).
intervention type: Drug
intervention name: Methotrexate
description: Methotrexate up to 25mg/week as tolerated po or sc
arm group label: Standard care
other name: methotrexate sodium
intervention type: Drug
intervention name: Sulfasalazine
description: Sulfasalazine up to 3g daily po
arm group label: Standard care
other name: sulfasalazine pill
intervention type: Drug
intervention name: Leflunomide
description: Leflunomide 10-20mg daily po
arm group label: Standard care
other name: leflunomide pill
intervention type: Drug
intervention name: Methylprednisolone
description: For IA or IM injection 20-120mg
arm group label: Local/IM steroid injections
other name: methylprednisolone acetate
intervention type: Drug
intervention name: Triamcinolone
description: For IA or IM injection 20-120mg
arm group label: Local/IM steroid injections
other name: triamcinolone acetonide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Sulfasalazine
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Methotrexate
mesh term: Triamcinolone diacetate
mesh term: Leflunomide
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: Undecided
ipd description: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.
point of contact: 