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A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) (focuSSced)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02453256
Recruitment Status : Active, not recruiting
First Posted : May 25, 2015
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: Placebo Drug: Tocilizumab Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
Actual Study Start Date : November 20, 2015
Estimated Primary Completion Date : January 16, 2018
Estimated Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Tocilizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Double-Blind Placebo
Participants will receive double-blind matching placebo from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
Drug: Placebo
Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.
Drug: Tocilizumab
Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment.
Experimental: Double-Blind Tocilizumab
Participants will receive double-blind tocilizumab from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
Drug: Tocilizumab
Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment.


Outcome Measures

Primary Outcome Measures :
  1. Change in Modified Rodnan Skin Score (mRSS) [ Time Frame: From Baseline to Week 48 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Greater Than or Equal to (>/=) 20%, 40%, or 60% Improvement in mRSS [ Time Frame: From Baseline to Week 48 ]
  2. Change in Forced Vital Capacity (FVC) [ Time Frame: From Baseline to Week 48 ]
  3. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: From Baseline to Week 48 ]
  4. Change in Patient Global Assessment Score [ Time Frame: From Baseline to Week 48 ]
  5. Change in Physician Global Assessment Score [ Time Frame: From Baseline to Week 48 ]
  6. Time to Treatment Failure According to mRSS, FVC, or Protocol-Specified Event [ Time Frame: From Baseline to Week 48 ]
  7. Percentage of Participants with Adverse Events [ Time Frame: From Baseline until 8 weeks after treatment discontinuation (up to 104 weeks overall) ]
  8. Change in Digital Ulcer Count [ Time Frame: From Baseline until treatment discontinuation (up to 96 weeks) ]
  9. Percentage of Participants with Anti-Tocilizumab Antibodies [ Time Frame: Baseline; during Weeks 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) ]
  10. Correlation Between Anti-Tocilizumab Antibody Status and Outcome Measures Pertaining to the Efficacy, Safety, and Pharmacokinetics of Tocilizumab [ Time Frame: Baseline; during Weeks 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) ]
  11. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Predose (0 hours) at Baseline; during Weeks 4, 24, 48, 72, 96, and/or at treatment discontinuation (up to 96 weeks) ]
  12. Serum Interleukin (IL)-6 Level [ Time Frame: Predose (0 hours) at Baseline; during Weeks 4, 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks) ]
  13. Serum Soluble IL-6 Receptor (sIL-6R) Level [ Time Frame: Predose (0 hours) at Baseline; during Weeks 4, 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) ]
  14. Serum C-Reactive Protein (CRP) Level [ Time Frame: Predose (0 hours) at Baseline; during Weeks 4, 24, 48, 72, 96, and/or at treatment discontinuation (up to 96 weeks) ]
  15. Serum Tocilizumab Concentration [ Time Frame: Predose (0 hours) at Baseline; during Weeks 4, 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) ]
  16. Correlation Between Serum Tocilizumab Concentration and Outcome Measures Pertaining to the Efficacy, Safety, and Immunogenicity of Tocilizumab [ Time Frame: Predose (0 hours) at Baseline; during Weeks 4, 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SSc according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and with total disease duration of less than or equal to (</=) 60 months
  • mRSS of 10-35 units, inclusive
  • Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential

Exclusion Criteria:

  • Pregnant or lactating females
  • Major surgery within 8 weeks prior to screening
  • Scleroderma limited to the face or areas distal to the elbows or knees
  • Rheumatic autoimmune disease other than SSc
  • Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline
  • Known hypersensitivity to human, humanized, or murine monoclonal antibodies
  • Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or gastrointestinal (GI) disease not related to SSc, including diverticulitis or ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to screening
  • Active or significant history of infection, including treatment with intravenous (IV) antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening
  • Significant history of tuberculosis (TB)
  • Primary or secondary immunodeficiency
  • Malignant disease, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  • History of drug or alcohol abuse
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453256


  Show 106 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02453256     History of Changes
Other Study ID Numbers: WA29767
2015-000424-28 ( EudraCT Number )
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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