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.

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic DMARD. Anticipated time on study treatment is 52 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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• Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug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