Status:
APPROVED_FOR_MARKETING
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adal...
Eligibility Criteria
Inclusion
- Males and females \>= 18 years of age
- ACR criteria for RA diagnosis for at least 6 months
- Active RA defined as a DAS 28 \>3.2 at study entry
- Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
- A negative pregnancy test for females of childbearing potential
Exclusion
- Patient who had previous treatment with cyclophosphamide and chlorambucil
- Treatment within the last 8 weeks with infliximab
- Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
- Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
- History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
- Prior treatment with total lymphoid irradiation
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00650390
Last Update
April 1 2008
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