A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.

Launched by HOFFMANN-LA ROCHE · Sep 3, 2010

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Eligibility criteria

• Inclusion Criteria:
• • Adult patients, \>/= 18 years of age
• • Moderate to severe active rheumatoid arthritis of \>/= 6 months duration
• • DAS28 \>/= 3.2 at screening and baseline
• • Inadequate response to biologic or non-biologic DMARDs
• • Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug
• • If continuing on a non-biologic DMARD, dose should be stable for at least 8 weeks
• • Oral corticosteroids must have been at stable dose for at least 25 out of 28 days prior to baseline
• Exclusion Criteria:
• • Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
• • Rheumatic autoimmune disease other then RA
• • Functional class IV as defined by the American College of Rheumatology (ACR) classification
• • Prior history of or current inflammatory joint disease other than RA
• • Previous treatment with any cell-depleting therapies
• • Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
• • Active infection or history of recurrent infection
• • Positive for HIV or hepatitis B or C
• • History of or current primary or secondary immunodeficiency