A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
- Registration Number
- NCT00233571
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 796
Inclusion Criteria
- Completion of a previous D2E7 study
- Subject is in good health (Investigator discretion) with a recent stable medical history
Exclusion Criteria
- Former enrollment in this trial (DE018)
- Subject is 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adalimumab 40mg subcutaneous (SC) every other week (EOW) Adalimumab 40 mg subcutaneous (SC) every other week (EOW) Adalimumab 40mg subcutaneous (SC) every other week (EOW)
- Primary Outcome Measures
Name Time Method Clinical response indicators 5 years
- Secondary Outcome Measures
Name Time Method Safety parameters 5 years