Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis (RADAR)

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01162421
First received: May 25, 2010
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.

Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Drug: Methotrexate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis Patients

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants With No Radiographic Progression at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.


Secondary Outcome Measures:
  • Percentage of Participants With No Radiographic Progression at Month 6 and Month 24 [ Time Frame: Baseline, Month 6, Month 24 ] [ Designated as safety issue: No ]
    Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

  • Change From Baseline in mTSS at Months 6, 12 and 24 [ Time Frame: Baseline, Month 6, Month 12, Month 24 ] [ Designated as safety issue: No ]
    The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

  • Percentage of Participants With Rapid Radiographic Progression at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Radiographic progression was defined as a change from Baseline in mTSS that is ≥ 5 units. The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

  • Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]

    A participant is an ACR20 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
      • Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein [CRP]).

  • Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]

    A participant is an ACR50 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
      • Acute phase reactant (erythrocyte sedimentation rate/CRP).

  • Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]

    A participant is an ACR70 responder if the following 3 criteria for improvement from Baseline are met:

    • ≥ 70% improvement in tender joint count;
    • ≥ 70% improvement in swollen joint count; and
    • ≥ 70% 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
      • Acute phase reactant (erythrocyte sedimentation rate/CRP).

  • Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-66, with higher scores indicating more swollen joints.

  • Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.

  • Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-68, with higher scores indicating more tender joints.

  • Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.

  • Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Physicians were asked to indicate the participant's disease activity (independent of the participant's self assessment) on a visual analogue scale (VAS) from 0 (very good) to 100 (very bad). A negative change from Baseline indicates improvement.

  • Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Participants were asked to indicate how they were doing with their RA on a VAS from 0 (very well) to 100 (very poorly). A negative change from Baseline indicates improvement.

  • Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Participants were asked to indicate how severe their pain had been in the previous week on a VAS from 0 (no pain) to 100 (pain as bad as it could be). A negative change from Baseline indicates improvement.

  • Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

  • Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    DAS28(CRP) remission was defined as DAS28(CRP) < 2.6. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

  • Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    DAS28(CRP) low disease activity was defined as DAS28(CRP) < 3.2. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

  • Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of ≥ 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.

  • Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and < 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or an improvement (decrease) in the DAS28 of ≥ 1.2 from Baseline and attainment of a DAS28 score of > 3.2.

  • Percentage of Participants With Flare-Up After Remission by Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 < 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

  • Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    HAQ is a participant-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. A lower HAQ-DI score is better.

  • Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-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. A lower HAQ-DI score is better.

  • Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The percentage of participants achieving HAQ < 0.5. HAQ is a participant-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. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. A lower HAQ-DI score is better.

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.

  • Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale.

  • Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work.

  • Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state).

  • Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'

  • Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.

  • Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 [ Time Frame: Months 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
    Participants measured their satisfaction with care by specifying their in response to the question "How satisfied are you with the results of your RA treatment?" on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care.

  • Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC).

  • HCR: Medical Insurance at Final Visit [ Time Frame: Final Visit (up to Month 24) ] [ Designated as safety issue: No ]
    The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC).

  • HCR: Health Care for RA in the Past 4 Weeks at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.

  • HCR: Health Care for RA in the Past 4 Weeks at Final Visit [ Time Frame: Final Visit (up to Month 24) ] [ Designated as safety issue: No ]
    The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.

  • HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.

  • HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit [ Time Frame: Final Visit (up to Month 24) ] [ Designated as safety issue: No ]
    The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.


Enrollment: 77
Study Start Date: September 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Adalimumab
Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration.
Biological: adalimumab
Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.
Other Names:
  • ABT-D2E7
  • Humira
Drug: Methotrexate
Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Other Names:
  • Trexall
  • Rheumatrex
Active Comparator: Standard of Care
Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.
Biological: adalimumab
Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.
Other Names:
  • ABT-D2E7
  • Humira
Drug: Methotrexate
Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Other Names:
  • Trexall
  • Rheumatrex

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has a diagnosis of Rheumatoid Arthritis as defined by the 1987-revised American College of Rheumatology-classification criteria and has disease duration of less than 2 years from diagnosis.
  2. Subject must have been on a dose of methotrexate therapy either subcutaneously or orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and has had an inadequate response to treatment defined as having a Disease Activity Score DAS28 > 3.2 (at Screening visit).
  3. Subject must also meet the following three criteria (at screening visit): at least 4 swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed; subject must have an elevated erythrocyte sedimentation rate >/= 20 mm/1h or C-reactive protein > upper limit of normal.
  4. Subject must fulfill at least one of the following three criteria: history of rheumatoid factor positive; history of at least one erosion on X-ray or magnetic resonance imaging; history of anti-cyclic-citrullinated protein antibody positive.

Exclusion Criteria:

  1. Subject has previous exposure to any biologic therapy including adalimumab.
  2. Prior disease-modifying antirheumatic drugs triple therapy with methotrexate.
  3. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks prior to baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
  4. Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of Baseline.
  5. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162421

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Mount Sinai Hospital, Canada
Investigators
Study Director: Christina Pelizon, MD AbbVie Corporation
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01162421     History of Changes
Other Study ID Numbers: W12-122 
Study First Received: May 25, 2010
Results First Received: July 22, 2016
Last Updated: September 13, 2016
Health Authority: Canada: Health Canada

Keywords provided by AbbVie:
Rheumatoid Arthritis
Anti-Inflammatory
Biological Therapy
adalimumab
Disease-Modifying Antirheumatic Drugs
Antirheumatic Agents
Agents

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on December 02, 2016