A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is <100.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- adult patients, >/=18 years of age
- moderate to severe rheumatoid arthritis of >/=6 months duration
- synovitis (swollen and tender joint) in the wrist of the dominant hand
- non-biologic DMARDs at stable dose for >/=12 weeks prior to baseline
- oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline
Exclusion criteria
- rheumatic autoimmune disease other than RA
- history of or current inflammatory joint disease other than RA
- functional class IV (ACR classification)
- intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- previous treatment with a biologic agent for RA
Trial design
Primary purpose
Allocation
Interventional model
Masking
54 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal