Status:
APPROVED_FOR_MARKETING
Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis
Eligibility Criteria
Inclusion
- Eighteen years or older
- Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
- Females - negative pregnancy test at screening
- Confirmed diagnosis of active RA \>= 6 swollen joints and \>= 9 tender joints
- Met ACR criteria for diagnosis of RA for at least 3 months
- Active RA defined by a DAS \>= 3.2 at study entry
Exclusion
- Subject had prior treatment with cyclophosphamide or chlorambucil
- Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
- Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
- Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00650026
Last Update
April 14 2008
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