A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | September 2010 |
End Date: | December 2013 |
Contact: | Please reference Study ID Number: WA22762 www.roche.com/about_roche/roche_worldwide.htm |
Email: | genentechclinicaltrials@druginfo.com |
Phone: | 888-662-6728 (U.S. Only) |
A Randomized, Double-blind, Parallel Group Study Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis
This randomized, double-blind, parallel group study will compare the efficacy and safety of
subcutaneous (sc) versus intravenous (iv) administration of RoActemra/Actemra (tocilizumab)
in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized
to receive either RoActemra/Actemra 162 mg sc weekly plus iv placebo every 4 weeks, or
RoActemra/Actemra 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind
period from baseline to Week 24. The double-blind period will be followed by a 72-week
open-label treatment with some switching of sc and iv administration. No placebo will be
administered in the open-label phase. Patients will continue on their stable dose of
disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on
study treatment is 2 years.
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Rheumatoid arthritis of >/= 6 months duration, according to American College of
Rheumatology (ACR) criteria
- Swollen joint count (SJC) >/= 4 (66 joint count), tender joint count (TJC) >/= 4 (68
joint count) at screening and baseline
- Inadequate response to current DMARD therapy
- Permitted DMARDs must be at stable dose for >/= 8 weeks prior to baseline
- Oral corticosteroids (= 10 mg/day prednisone or equivalent) and NSAIDs (up to
maximum recommended dose) must be at stable dose for >/= 4 weeks prior to baseline
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than RA
- Functional class IV (ACR classification)
- Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis
(JRA) and/or RA before the age of 16
- Prior history of or current inflammatory joint disease other than RA
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Previous treatment with RoActemra/Actemra
- Active current or history of recurrent infection
We found this trial at
25
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