A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

• Phase: Phase 4
• 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

• inadequate response, or intolerance to previous therapy with one or more traditional DMARDs

• DAS >3.6

• pneumology examination (including chest x-ray and quantiferon)

Exclusion Criteria:

• < 18 years of age

• active infection

• active tuberculosis

• uncontrolled hyperlipoproteinaemia

• demyelinating disorders

• concomitant anti-TNF drugs

• history of intestinal ulceration and diverticulitis