Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00234936
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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 ACR criteria
- Subjects with treatment failure criteria to Mtx or Mtx + another DMARD
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Exclusion Criteria
- 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
- Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method QOL 12 months
- Secondary Outcome Measures
Name Time Method Patient reported outcomes Clinical response indicators Safety parameters