Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)
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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 adalimumab in subjects previously treated with infliximab.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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
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