Rheumatoid Arthritis Clinical Trial
Official title:
Open Label, Multicenter Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) of the Hand of Patients With Rheumatoid Arthritis
Verified date | March 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | ITALY: Italian Medicines Agency |
Study type | Interventional |
This open-label, single arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Patients will receive tocilizumab (8mg/kg iv infusion) every 4 weeks in addition to their current DMARD therapy. Anticipated time on study treatment is 48 weeks, and the target sample size is <100.
Status | Completed |
Enrollment | 58 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients, >/=18 years of age - moderate to severe active rheumatoid arthritis of >/=6 months duration - DAS >/=3.2 - inadequate response to a stable dose of DMARDs - patients receiving oral corticosteroids must have been at stable dose on >/=25 days in the 28 days prior to first study treatment Exclusion Criteria: - rheumatic autoimmune disease other than RA - history of or current joint disease other than RA - previous treatment with a biologic - intraarticular or parenteral corticosteroids within 6 weeks prior to baseline - previous treatment with any cell-depleting therapies - functional class IV (ACR) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect on synovitis, bone marrow edema and erosions, assessed by MRI of the hand | weeks 4, 8, 12, 24 and 48 | No | |
Secondary | Early effect on synovitis, bone marrow edema and erosions, assessed by MRI of the hand | day 15 | No | |
Secondary | Clinical response: DAS 28, HAQ, VAS, ESR, CRP, VGEF, Hb | assessed every 4 weeks | No | |
Secondary | AEs, laboratory parameters | throughout study, laboratory parameters assessed every 4 weeks | No |
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