A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
76 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal