A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Clalit Health Services

Criteria

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Active moderate to severe rheumatoid arthritis

• Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)

• Current treatment at stable dose for >/=8 weeks

• Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell repletion

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline

• Rheumatic autoimmune disease other than RA

• Functional class IV (American College of Rheumatology Classification)

• Prior history or current inflammatory joint disease other than RA

• Oral corticosteroids at a dose of >10 mg/day prednisone equivalent

• Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody

• Current or history of recurrent bacterial, viral, fungal or mycobaterial infection

• History of or currently active primary or secondary immunodeficiency