Clinical trial NCT01162421: A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Anti-Inflammatory
Biological Therapy
adalimumab
Disease-Modifying Antirheumatic Drugs
Antirheumatic Agents
Agents
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2010-07-14
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With No Radiographic Progression at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percentage of Participants With No Radiographic Progression at Month 6 and Month 24
timeFrame: Baseline, Month 6, Month 24
measure: Change From Baseline in mTSS at Months 6, 12 and 24
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Percentage of Participants With Rapid Radiographic Progression at Month 12
timeFrame: Month 12
measure: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants With Flare-Up After Remission by Month 24
timeFrame: Month 24
measure: Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 3, 6, 9, 12, 18, 24
measure: Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24
timeFrame: Months 3, 6, 9, 12, 18, 24
measure: Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline
timeFrame: Baseline
measure: HCR: Medical Insurance at Final Visit
timeFrame: Final Visit (up to Month 24)
measure: HCR: Health Care for RA in the Past 4 Weeks at Baseline
timeFrame: Baseline
measure: HCR: Health Care for RA in the Past 4 Weeks at Final Visit
timeFrame: Final Visit (up to Month 24)
measure: HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline
timeFrame: Baseline
measure: HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit
timeFrame: Final Visit (up to Month 24)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Corporation
name: Christina Pelizon, MD
role: STUDY_DIRECTOR
References: