A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2011-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients, 18-75 years of age

• rheumatoid arthritis (RA) of >6 months duration

• able to receive outpatient treatment

• on methotrexate for at least 12 weeks before entering study, at a stable dose of 7.5-25 mg/week for the last 8 weeks

• oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) permitted, if at a stable dose for 4 weeks before study start

Exclusion Criteria

• major surgery (including joint surgery) within 8 weeks prior to screening, or planned surgery within 6 months after entering study

• history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA

• inadequate response to anti-tumor necrosis factor (TNF) agent during the 6 months prior to baseline, or inadequate response to >2 anti-TNF agents

• initiation of treatment with lipid lowering agents within 12 weeks prior to baseline