A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Rheumatoid arthritis of >/= 1 year duration

• Mild to moderate disease activity at screening (DAS 282.6)

• On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1

• Body weight
• Oral corticosteroids must have been at stable dose (maximum 10 mg/day) 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 planned major surgery within 6 months after baseline

• Rheumatic autoimmune disease other than rheumatoid arthritis

• Functional class IV American College of Rheumatology (ACR) Classification

• Prior history of or current inflammatory joint disease other than rheumatoid arthritis

• 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 tocilizumab

• Pregnant or lactating women

• Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids

• Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections

• History of or currently active primary or secondary immunodeficiency

• Evidence of active malignant disease, malignancies diagnosed within the previous 5 years

• Active tuberculosis requiring treatment within the previous 3 years

• Positive for HIV infection