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
  Purpose

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.


Condition Intervention Phase
Sclerosis, Systemic
Drug: Placebo
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in modified Rodnan skin score (mRSS) [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Subcutaneously weekly, Weeks 1-48
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Week 49-96
Experimental: Tocilizumab Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Weeks 1-48
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Week 49-96

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532869

  Show 50 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01532869     History of Changes
Other Study ID Numbers: WA27788, 2011-001460-22
Study First Received: February 10, 2012
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014