A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline

• Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)

• Body weight < 150 kg

• Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

Exclusion Criteria:

• Pregnant or nursing women

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

• Rheumatic autoimmune disease other than RA

• Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis

• Prior history of or current inflammatory joint disease other than RA

• Treatment with a biologic agent at any time prior to baseline

• Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline

• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

• Previous treatment with RoActemra/Actemra

• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies

• Known active current or history of recurrent infection

• History of or currently active primary or secondary immunodeficiency

• Active tuberculosis requiring treatment within the previous 3 years

• Positive for HIV infection