Trial Search Results

A Study of RoActemra/Actemra (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 participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):


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


Phase 3


Inclusion Criteria:

   - Adult patients, >/= 18 years of age

   - Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria

   - Disease duration of    manifestation)

   - >/= 15 and
   - Active disease, as defined by protocol

   - Uninvolved skin at injection sites

   - Negative pregnancy test for a female subject of childbearing potential

Exclusion Criteria:

   - Major surgery (including joint surgery) within 8 weeks prior to and/or during study

   - Rheumatic autoimmune disease other than systemic sclerosis

   - Skin thickening (scleroderma) limited to areas distal to the elbows or knees at

   - Previous treatment with tocilizumab

   - History of severe allergic or anaphylactic reactions to human, humanized, or murine
   monoclonal antibodies

   - Severe cardiopulmonary disease

   - Known active current or history of recurrent infections

   - Use of any investigational, biologic, or immunosuppressive therapies including
   intra-articular or parenteral corticosteroids prior to study enrollment as specified
   in the protocol

   - As specified in the protocol, any current or past medical condition or medical history
   involving but not limited to the nervous, renal, pulmonary, endocrine, and
   gastrointestinal organ systems determined by the Principal Investigator to pose a
   significant safety risk to any subject while participating in the study

   - Primary or secondary immunodeficiency

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amanda Foster
Not Recruiting