Status:
COMPLETED
Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis
Eligibility Criteria
Inclusion
- Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
- Subject must be in paid employment
- Subject has self-reported work impairment since onset of symptoms
Exclusion
- A subject has chronic arthritis diagnosed before age 16 years.
- Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
- Subject has preceding treatment with any biological TNF antagonist
- 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 :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00234845
Start Date
March 1 2003
Last Update
August 29 2007
Active Locations (1)
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1
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064