Overview
A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Status:
Completed
Completed
Trial end date:
2010-12-01
2010-12-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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.