Status:
COMPLETED
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and mai...
Detailed Description
This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-bli...
Eligibility Criteria
Inclusion
- Age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits \>=6 swollen joints and \>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints \[DIPs\] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \[DMARDs\] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)
- Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).
- If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
- Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
- Both rheumatoid factor positivity and a C-reactive protein value \>=1 mg/dL, or at least one joint erosion on X-ray.
Exclusion
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who was pregnant or breast-feeding or considering becoming pregnant.
- Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
- Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
- Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
- Subject was wheelchair bound or bedridden.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
619 Patients enrolled
Trial Details
Trial ID
NCT00195702
Start Date
February 1 2000
End Date
August 1 2010
Last Update
August 26 2011
Active Locations (87)
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1
Site Ref # / Investigator 424
Huntsville, Alabama, United States, 35801
2
Site Ref # / Investigator 2510
Mobile, Alabama, United States, 36608
3
Site Ref # / Investigator 60729
Phoenix, Arizona, United States, 85012
4
Site Ref # / Investigator 725
Scottsdale, Arizona, United States, 85260