Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00650026
- Lead Sponsor
- Abbott
- Brief Summary
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method