Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis (ReAct)

Abbott

Status

Conditions: Rheumatoid Arthritis

Treatments: Biological: adalimumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00650026

M03-583

Details and patient eligibility

About

Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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