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:
Participant gender:
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.