Status:
COMPLETED
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthrit...
Detailed Description
This was a 78-week, multicenter, randomized, double-blind, double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early R...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject must be 18 or older and in good health
- Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis
- Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
- Subject must fulfill at least one of the following three criteria:
- Rheumatoid factor positive
- Greater than 1 joint erosion
- Anti-cyclic citrullinated peptide (CCP) antibody positive.
- Exclusion Criteria
- Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
- Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline
- Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT00420927
Start Date
December 1 2006
End Date
July 1 2010
Last Update
April 18 2012
Active Locations (170)
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1
Site Reference ID/Investigator# 4560
Birmingham, Alabama, United States, 35205
2
Site Reference ID/Investigator# 4547
Birmingham, Alabama, United States, 35294-7201
3
Site Reference ID/Investigator# 6222
Huntsville, Alabama, United States, 35801
4
Site Reference ID/Investigator# 4537
Mobile, Alabama, United States, 36608