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Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a systemic inflammatory disease characterized by chronic inflammation in the synovial membrane of affected joints, which ultimately leads to loss of daily function because of deformity, chronic pain, and fatigue. RA affects approximately 0.5%–1% of the adult population in North America. The majority of patients with RA experience progressive deterioration of cartilage and bone in the affected joints, which may eventually lead to permanent disability.

The primary objective of this study is to characterize the safety of Drug X when used in
combination with other disease-modifying anti-rheumatic drugs (DMARDs) in subjects with active RA. The secondary objective is to characterize the safety of re-treatment with Drug X when used in combination with other DMARDs.

The basic inclusion criteria are as follows:

  • Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active RA for at least 6 months;
  • Receiving treatment for RA on an outpatient basis;
  • Have had an inadequate response to at least one non-biologic DMARD and have been receiving this DMARD(s) for at least 12 weeks prior to baseline, with the dose being stable for 4 weeks prior to baseline;
  • Demonstrated tolerability to currently prescribed DMARDs; and
  • no history of or current inflammatory joint disease other than RA (e.g., gout, calcium pyrophosphate deposition disease, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, Still’s disease, mixed connective tissue disease, or any overlap syndrome).
  • If taking a background corticosteroid (e.g., prednisone), use of the corticosteroid must be at a stable dose during the 4 weeks prior to starting this study.
  • Use of one nonsteroidal anti-inflammatory drug (NSAID) is permitted if the dose is stable for at least 2 weeks prior to starting this study.

Treatment on the study lasts for 2 years, plus another 2 years of safety follow-up.

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