A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• active moderate or severe rheumatoid arthritis;

• active disease for >6 months;

• inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.

Exclusion Criteria:

• rheumatic autoimmune disease other than rheumatoid arthritis;

• prior history of, or current inflammatory joint disease other than rheumatoid arthritis;

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