A PHASE II/III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with systemic sclerosis. Patients will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 49 to Week 96, all patients will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : tocilizumab [RoActemra/Actemra]
  • drug : tocilizumab [RoActemra/Actemra]
  • drug : Placebo

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Adult patients, >/= 18 years of age - Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria - Disease duration of </= 60 months (defined as time from first non-Raynaud phenomenon manifestation) - >/= 15 and </= 40 mRSS units at screening - Active disease, as defined by protocol - Uninvolved skin at injection sites - Negative pregnancy test for a female subject of childbearing potential

External Links

Contact information

Primary Contact:

Amanda Foster 6507217147

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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