Rheumatoid Arthritis
Conditions
Brief summary
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis
Interventions
BIOLOGICALadalimumab
40 mg adalimumab every other week
Sponsors
Abbott
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Outcome results
None listed