Trial Information

Summary: A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) versus Placebo in Combination with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)

The ROSE Rheumatoid Arthritis Study is being conducted in people diagnosed with moderate to severe active rheumatoid arthritis (RA), a progressive condition characterized by inflammation of the membrane lining in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversable joint destruction and disability. Non-steroidal anti-inflammatory drugs (NSAIDS), disease modifying antirheumatic drugs (DMARDs) such as Methotrexate (MTX) and biological compounds have all been used to treat RA, however there are disadvantages with each treatment. Interleukin-6 (IL-6) is a protein produced by a variety of cell types and has been implicated in the pathogenesis of a variety of diseases including inflammatory rheumatic diseases. Tocilizumab is an Interleukin-6 receptor antibody that has been shown to prevent bone and cartilage destruction in certain animal studies.

This study has been designed to demonstrate the response of Tocilizumab along with MTX as a novel approach to the treatment of RA and, therefore, may offer an alternative for patients who have had inadequate response to MTX alone or in combination with other DMARDs. Studies in the past have shown that Tocilizumab plus MTX combination therapy achieves better efficacy than MTX alone and has acceptable safety profile with patients with RA.

During the study, approx. every 4 weeks, patients will receive either Tocilizumab or Placebo via 1 hour IV infusion (Total of 6 infusions). A patient will have 66% chance of receiving Tocilizumab IV.

Patient Inclusion Criteria:

• 18 years or older
• Diagnosis of RA >6 months duration
• Received Methotrexate for at least 12 weeks immediately prior to baseline, of which the 8 weeks prior to baseline was at stable dose of between 10 and 25 mg/week.
• >6 swollen and >6 tender joint counts at screening
• Either C-reactive proteine (CRP) >1 mg/dL OR ESR (Sed Rate) >28 mm/hr at screening

(Other Inclusion Criteria Apply)

Patient Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks
• Rheumatic autoimmune disease other than RA.
• Prior history of or current inflammatory joint disease other than RA.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.