A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01532869
First received: February 10, 2012
Last updated: August 26, 2014
Last verified: August 2014

February 10, 2012
August 26, 2014
April 2012
June 2015   (final data collection date for primary outcome measure)
  • Change in modified Rodnan skin score (mRSS) [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01532869 on ClinicalTrials.gov Archive Site
  • Change in physical function, assessed by Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI) [ Designated as safety issue: No ]
  • Change in joint tenderness, assessed by 28 tender joint count (TJC), in patients with joint involvement at baseline [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration--time curve (AUC) [ Designated as safety issue: No ]
  • Pharmacodynamics: sIL-6R/IL-6 levels [ Designated as safety issue: No ]
  • Immunogenicity: anti-tocilizumab antibody level [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
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, paralle l-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocili zumab) in patients with systemic sclerosis. Patients will be randomized to recei ve 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/Actemr a 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sclerosis, Systemic
  • Drug: Placebo
    Subcutaneously weekly, Weeks 1-48
  • Drug: tocilizumab [RoActemra/Actemra]
    162 mg subcutaneously weekly, Weeks 1-48
  • Drug: tocilizumab [RoActemra/Actemra]
    162 mg subcutaneously weekly, Week 49-96
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: tocilizumab [RoActemra/Actemra]
  • Experimental: Tocilizumab
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
87
June 2015
June 2015   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
  • Rheumatic autoimmune disease other than systemic sclerosis
  • Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   United Kingdom
 
NCT01532869
WA27788, 2011-001460-22
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP