Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)

Abbott

Status

Conditions: Rheumatoid Arthritis

Treatments: Biological: adalimumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00650390

M02-532

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Prior treatment with total lymphoid irradiation