Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00234845
- Lead Sponsor
- Abbott
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Job loss measurement
- Secondary Outcome Measures
Name Time Method Job productivity measurements DAS28 Patient reported outcomes Safety parameters
Trial Locations
- Locations (1)
Global Medical Information - Abbott
🇺🇸Abbott Park, Illinois, United States