<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/NCT01712178</url>
  </required_header>
  <id_info>
    <org_study_id>M13-390</org_study_id>
    <secondary_id>2012-000535-36</secondary_id>
    <nct_id>NCT01712178</nct_id>
  </id_info>
  <brief_title>A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety</brief_title>
  <official_title>Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for&#xD;
      pharmacodynamics, pharmacokinetics, and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Concentrations of Adalimumab at Weeks 12 and 24</measure>
    <time_frame>Measured at Weeks 12 and 24</time_frame>
    <description>Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Disease Activity Scores (DAS28) at Weeks 12 and 24</measure>
    <time_frame>Measured at Weeks 12 and 24</time_frame>
    <description>The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24</measure>
    <time_frame>Measured at Weeks 12 and 24</time_frame>
    <description>American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:&#xD;
≥ 20% improvement in tender joint count;&#xD;
≥ 20% improvement in swollen joint count; and&#xD;
≥ 20% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Disability Index of the Health Assessment Questionnaire&#xD;
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24</measure>
    <time_frame>Measured at Weeks 12 and 24</time_frame>
    <description>American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:&#xD;
≥ 50% improvement in tender joint count;&#xD;
≥ 50% improvement in swollen joint count; and&#xD;
≥ 50% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Disability Index of the Health Assessment Questionnaire&#xD;
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24</measure>
    <time_frame>Measured at Weeks 12 and 24</time_frame>
    <description>The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI &lt; 0.5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24</measure>
    <time_frame>Measured at Weeks 12 and 24</time_frame>
    <description>The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Positive for Anti-adalimumab Antibody</measure>
    <time_frame>Measured through Week 24</time_frame>
    <description>Percentage of participants with anti-adalimumab antibody</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>From time of informed consent to 70 days following the last dose of study drug</time_frame>
    <description>An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Injection Site Pain on a Visual Analogue Scale (VAS)</measure>
    <time_frame>Immediately after injections on Day 1</time_frame>
    <description>The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing &quot;no pain&quot; and 100 representing &quot;worst possible pain&quot;. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>New formulation of adalimumab 40 mg every other week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New formulation adalimumab 40 mg every other week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Current formulation adalimumab 40 mg every other week</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current formulation adalimumab 40 mg every other week</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab, current formulation</intervention_name>
    <description>Current formulation adalimumab 40 mg every other week</description>
    <arm_group_label>Current formulation adalimumab 40 mg every other week</arm_group_label>
    <other_name>Humira</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab, new formulation</intervention_name>
    <description>New formulation adalimumab 40 mg every other week</description>
    <arm_group_label>New formulation of adalimumab 40 mg every other week</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis&#xD;
             (RA) as defined by the 1987-revised American College of Rheumatology&#xD;
             (ACR)-classification criteria or the new American College of Rheumatology&#xD;
             (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA&#xD;
             2010-classification criteria and has a disease duration for a minimum of 3 months.&#xD;
&#xD;
          -  Subjects must be naïve to biologic therapy.&#xD;
&#xD;
          -  Subject must meet the following criteria for the joint assessment: • At least 6&#xD;
             swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.&#xD;
&#xD;
          -  Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not on&#xD;
             methotrexate at baseline must remain without methotrexate throughout the study.&#xD;
             Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior to&#xD;
             Week 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapy&#xD;
             other than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10&#xD;
             mg) must discontinue it for at least 28 days before the first dose of investigational&#xD;
             product at Week 0 (Day 1).&#xD;
&#xD;
          -  Female subjects are either not of childbearing potential, defined as postmenopausal&#xD;
             for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral&#xD;
             oophorectomy and/or hysterectomy), or are practicing at least 1 of the following&#xD;
             methods of birth control throughout the study and for at least 150 days after the last&#xD;
             dose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterine&#xD;
             device (IUD). • Hormonal contraceptives for 90 days prior to study drug&#xD;
             administration. • Vasectomized partner(s).&#xD;
&#xD;
          -  Subjects must be able and willing to self-administer subcutaneous (SC) injections or&#xD;
             have a qualified person available to administer subcutaneous (SC) injections.&#xD;
&#xD;
          -  Subject is judged to be in good general health as determined by the Principal&#xD;
             Investigator based upon the results of medical history, physical examination,&#xD;
             laboratory profile, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performed&#xD;
             during Screening.&#xD;
&#xD;
          -  Subject has a negative Tuberculosis (TB) screening assessment (including a (Purified&#xD;
             Protein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test or&#xD;
             equivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) at&#xD;
             Screening. If a subject has evidence of a latent Tuberculosis (TB) infection, the&#xD;
             subject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB)&#xD;
             therapy or have documented completion of a course of anti-Tuberculosis (TB) therapy&#xD;
             prior to Baseline.&#xD;
&#xD;
          -  Subjects must be willing to provide written consent and to comply with the&#xD;
             requirements of this study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has been treated with intra-articular or parenteral administration of&#xD;
             corticosteroids in the preceding 4 weeks from Baseline visit. Inhaled corticosteroids&#xD;
             for stable medical conditions are allowed. Oral of less than or equal to 10 mg/d&#xD;
             prednisone equivalent are allowed.&#xD;
&#xD;
          -  Subject has been treated with any investigational drug of a chemical or biological&#xD;
             nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug&#xD;
             prior to Baseline Visit.&#xD;
&#xD;
          -  Subject has a history of acute inflammatory joint disease of different origin other&#xD;
             than Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriatic&#xD;
             arthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or any&#xD;
             arthritis with onset prior to age 17 years).&#xD;
&#xD;
          -  Known hypersensitivity to adalimumab or its excipients.&#xD;
&#xD;
          -  Subject currently uses or plans to use anti-retroviral therapy at any time during the&#xD;
             study.&#xD;
&#xD;
          -  History of demyelinating disease (including myelitis) or neurologic symptoms&#xD;
             suggestive of demyelinating disease.&#xD;
&#xD;
          -  History of invasive infection (e.g., listeriosis and histoplasmosis), human&#xD;
             immunodeficiency syndrome (HIV).&#xD;
&#xD;
          -  Chronic recurring infections or active Tuberculosis (TB).&#xD;
&#xD;
          -  History of moderate to severe congestive heart failure (New York Heart Association&#xD;
             (NYHA) class III or IV), recent cerebrovascular accident and any other condition&#xD;
             which, in the opinion of the investigator, would put the subject at risk by&#xD;
             participation in the protocol.&#xD;
&#xD;
          -  Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other&#xD;
             than a successfully treated non-metastatic cutaneous squamous cell or basal cell&#xD;
             carcinoma or localized carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Subject received any live vaccine within 3 months prior to study drug administration.&#xD;
             - Subject has a history of clinically significant hematologic (e.g., severe anemia,&#xD;
             leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis,&#xD;
             hepatitis).&#xD;
&#xD;
          -  Positive pregnancy test at Screening or Baseline.&#xD;
&#xD;
          -  Subject is considered by the investigator, for any reason, to be unsuitable candidate&#xD;
             for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andy Payne, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75073</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75077</name>
      <address>
        <city>Hemet</city>
        <state>California</state>
        <zip>92543</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75076</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75075</name>
      <address>
        <city>Clifton</city>
        <state>New Jersey</state>
        <zip>07012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 83133</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75074</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75100</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75101</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75104</name>
      <address>
        <city>Brno</city>
        <zip>638 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76788</name>
      <address>
        <city>Prague 2</city>
        <zip>128 50</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75102</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 01</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75103</name>
      <address>
        <city>Zlin</city>
        <zip>760 01</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 78014</name>
      <address>
        <city>Ratingen</city>
        <zip>40882</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75079</name>
      <address>
        <city>Caguas</city>
        <zip>00725</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75078</name>
      <address>
        <city>Vega Baja</city>
        <zip>00693</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76787</name>
      <address>
        <city>Bucharest</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75978</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76433</name>
      <address>
        <city>Ploiesti</city>
        <zip>100337</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76934</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>97405</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76935</name>
      <address>
        <city>Senica</city>
        <zip>905 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76682</name>
      <address>
        <city>Zilina</city>
        <zip>010 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.</description>
  </link>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>June 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>May 7, 2014</results_first_submitted>
  <results_first_submitted_qc>June 10, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 11, 2014</results_first_posted>
  <last_update_submitted>June 10, 2014</last_update_submitted>
  <last_update_submitted_qc>June 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacodynamic,Pharmacokinetic</keyword>
  <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>Adalimumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
          <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
        </group>
        <group group_id="P2">
          <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
          <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrew consent due to an adverse event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Serious adverse event/withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
          <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
        </group>
        <group group_id="B2">
          <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
          <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</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="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.5" spread="11.0"/>
                    <measurement group_id="B2" value="53.0" spread="12.3"/>
                    <measurement group_id="B3" value="54.3" spread="11.6"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Serum Concentrations of Adalimumab at Weeks 12 and 24</title>
        <description>Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.</description>
        <time_frame>Measured at Weeks 12 and 24</time_frame>
        <population>Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Concentrations of Adalimumab at Weeks 12 and 24</title>
          <description>Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.</description>
          <population>Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12: n= 46 (new), n=43 (current)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.72" spread="4.49"/>
                    <measurement group_id="O2" value="6.23" spread="4.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: n= 47 (new), n=41 (current)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.95" spread="5.13"/>
                    <measurement group_id="O2" value="6.17" spread="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Disease Activity Scores (DAS28) at Weeks 12 and 24</title>
        <description>The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 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>Measured at Weeks 12 and 24</time_frame>
        <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Disease Activity Scores (DAS28) at Weeks 12 and 24</title>
          <description>The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 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>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.78" spread="0.147"/>
                    <measurement group_id="O2" value="3.82" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.54" spread="0.152"/>
                    <measurement group_id="O2" value="3.46" spread="0.153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24</title>
        <description>American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:&#xD;
≥ 20% improvement in tender joint count;&#xD;
≥ 20% improvement in swollen joint count; and&#xD;
≥ 20% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Disability Index of the Health Assessment Questionnaire&#xD;
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))</description>
        <time_frame>Measured at Weeks 12 and 24</time_frame>
        <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24</title>
          <description>American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:&#xD;
≥ 20% improvement in tender joint count;&#xD;
≥ 20% improvement in swollen joint count; and&#xD;
≥ 20% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Disability Index of the Health Assessment Questionnaire&#xD;
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))</description>
          <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.0"/>
                    <measurement group_id="O2" value="68.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.0"/>
                    <measurement group_id="O2" value="68.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24</title>
        <description>American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:&#xD;
≥ 50% improvement in tender joint count;&#xD;
≥ 50% improvement in swollen joint count; and&#xD;
≥ 50% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Disability Index of the Health Assessment Questionnaire&#xD;
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))</description>
        <time_frame>Measured at Weeks 12 and 24</time_frame>
        <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24</title>
          <description>American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:&#xD;
≥ 50% improvement in tender joint count;&#xD;
≥ 50% improvement in swollen joint count; and&#xD;
≥ 50% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Disability Index of the Health Assessment Questionnaire&#xD;
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))</description>
          <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0"/>
                    <measurement group_id="O2" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24</title>
        <description>The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI &lt; 0.5.</description>
        <time_frame>Measured at Weeks 12 and 24</time_frame>
        <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24</title>
          <description>The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI &lt; 0.5.</description>
          <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.075"/>
                    <measurement group_id="O2" value="1.02" spread="0.076"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="0.082"/>
                    <measurement group_id="O2" value="0.97" spread="0.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24</title>
        <description>The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.</description>
        <time_frame>Measured at Weeks 12 and 24</time_frame>
        <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24</title>
          <description>The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.</description>
          <population>All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCS score- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.88" spread="0.957"/>
                    <measurement group_id="O2" value="39.08" spread="0.974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS score- Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.38" spread="1.044"/>
                    <measurement group_id="O2" value="39.94" spread="1.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS score- Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.78" spread="1.172"/>
                    <measurement group_id="O2" value="42.78" spread="1.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS score- Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.16" spread="1.246"/>
                    <measurement group_id="O2" value="45.46" spread="1.267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Positive for Anti-adalimumab Antibody</title>
        <description>Percentage of participants with anti-adalimumab antibody</description>
        <time_frame>Measured through Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Positive for Anti-adalimumab Antibody</title>
          <description>Percentage of participants with anti-adalimumab antibody</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.</description>
        <time_frame>From time of informed consent to 70 days following the last dose of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Injection Site Pain on a Visual Analogue Scale (VAS)</title>
        <description>The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing &quot;no pain&quot; and 100 representing &quot;worst possible pain&quot;. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.</description>
        <time_frame>Immediately after injections on Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
            <description>New formulation adalimumab 40 mg every other week&#xD;
Adalimumab, new formulation: New formulation adalimumab 40 mg every other week</description>
          </group>
          <group group_id="O2">
            <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
            <description>Current formulation adalimumab 40 mg every other week&#xD;
Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Injection Site Pain on a Visual Analogue Scale (VAS)</title>
          <description>The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing &quot;no pain&quot; and 100 representing &quot;worst possible pain&quot;. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.</description>
          <units>Millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="22.6"/>
                    <measurement group_id="O2" value="35.9" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of study drug administration until 70 days following the last dose. Serious adverse events were collected from the time the participant signed the informed consent.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>New Formulation of Adalimumab 40 mg Every Other Week</title>
        </group>
        <group group_id="E2">
          <title>Current Formulation Adalimumab 40 mg Every Other Week</title>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>THORACIC VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>TRANSITIONAL CELL CARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <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="23" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>INJECTION SITE REACTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RHEUMATOID ARTHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
    </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/NCT01712178
org study id: M13-390
secondary id: 2012-000535-36
nct id: NCT01712178
lead sponsor: 
has dmc: No
A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for
      pharmacodynamics, pharmacokinetics, and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Serum Concentrations of Adalimumab at Weeks 12 and 24
time frame: Measured at Weeks 12 and 24
description: Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.
measure: Mean Disease Activity Scores (DAS28) at Weeks 12 and 24
time frame: Measured at Weeks 12 and 24
description: The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 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: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24
time frame: Measured at Weeks 12 and 24
description: American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
≥ 20% improvement in tender joint count;
≥ 20% improvement in swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
measure: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24
time frame: Measured at Weeks 12 and 24
description: American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
≥ 50% improvement in tender joint count;
≥ 50% improvement in swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Disability Index of the Health Assessment Questionnaire
CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
measure: Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24
time frame: Measured at Weeks 12 and 24
description: The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
measure: Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24
time frame: Measured at Weeks 12 and 24
description: The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.
measure: Percentage of Participants Positive for Anti-adalimumab Antibody
time frame: Measured through Week 24
description: Percentage of participants with anti-adalimumab antibody
measure: Number of Participants With Adverse Events
time frame: From time of informed consent to 70 days following the last dose of study drug
description: An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.
measure: Mean Injection Site Pain on a Visual Analogue Scale (VAS)
time frame: Immediately after injections on Day 1
description: The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing "no pain" and 100 representing "worst possible pain". Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.
arm group label: New formulation of adalimumab 40 mg every other week
arm group type: Experimental
description: New formulation adalimumab 40 mg every other week
arm group label: Current formulation adalimumab 40 mg every other week
arm group type: Active Comparator
description: Current formulation adalimumab 40 mg every other week
intervention type: Biological
intervention name: Adalimumab, current formulation
description: Current formulation adalimumab 40 mg every other week
arm group label: Current formulation adalimumab 40 mg every other week
other name: Humira
intervention type: Biological
intervention name: Adalimumab, new formulation
description: New formulation adalimumab 40 mg every other week
arm group label: New formulation of adalimumab 40 mg every other week
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andy Payne, PhD
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Czech Republic
country: Germany
country: Puerto Rico
country: Romania
country: Slovakia
country: United States
url: http://rxabbvie.com
description: This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Adalimumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 