Status:
COMPLETED
Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Early Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety...
Detailed Description
This study had an initial 2-year double-blind treatment period followed by an 8-year open-label extension period, for a total of up to 10 years study duration. The study was designed to assess the pot...
Eligibility Criteria
Inclusion
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Diagnosis of rheumatoid arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR) criteria, with a disease duration less than 3 years, at least 8 swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68 joints assessed, at least 1 joint erosion or rheumatoid factor (RF) positivity, erythrocyte sedimentation rate (ESR) \>= 28 mm/1h or C-reactive protein (CRP) \>= 1.5 mg/dl
Exclusion
- Chronic arthritis diagnosed before the age of 16
- Preceding treatment with MTX, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (DMARDs)
- Subject previously received anti-tumor necrosis factor (TNF) therapy
- Permanently wheelchair-bound or bedridden patients
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
799 Patients enrolled
Trial Details
Trial ID
NCT00195663
Start Date
December 1 2000
End Date
April 1 2012
Last Update
July 12 2013
Active Locations (123)
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1
Site Reference ID/Investigator# 322
Scottsdale, Arizona, United States, 85260
2
Site Ref # / Investigator 95957
La Jolla, California, United States, 92037
3
Site Reference ID/Investigator# 429
La Jolla, California, United States, 92037
4
Site Reference ID/Investigator# 2491
Los Angeles, California, United States, 90048