A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration

• Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)

• Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

Exclusion Criteria:

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

• Autoimmune disease other than RA

• History of or current inflammatory joint disease other than RA

• Previous treatment with any biologic drug that is used in the treatment of RA

• Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline

• Impaired liver, renal or hematologic function

• Active current or history of recurrent infection

• History of or currently active primary or secondary immunodeficiency