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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01532869 |
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Date of registration:
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10/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
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Scientific title:
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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 |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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87 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01532869 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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France
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Germany
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sclerosis, Systemic
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Intervention(s)
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Drug: Placebo
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Drug: tocilizumab [RoActemra/Actemra]
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Primary Outcome(s)
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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: Week 48]
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Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
[Time Frame: Baseline, Week 24]
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Secondary Outcome(s)
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48
[Time Frame: Baseline, Weeks 24 and 48]
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Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
[Time Frame: Baseline, Weeks 24 and 48]
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Change From Baseline in 5-D Itch Scale at Week 24 and Week 48
[Time Frame: Baseline, Weeks 24 and 48]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48
[Time Frame: Baseline, Weeks 24 and 48]
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Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
[Time Frame: Baseline, Weeks 24 and 48]
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Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)
[Time Frame: Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16]
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Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48
[Time Frame: Baseline, Weeks 24 and 48]
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Mean Serum Concentrations of Interleukin (IL)-6 by Visit
[Time Frame: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48]
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Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48
[Time Frame: Week 48]
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Change From Baseline in Tender Joint Count 28 (TJC28)
[Time Frame: Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48]
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Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
[Time Frame: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48]
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Change From Baseline in mRSS at Week 48
[Time Frame: Baseline, Week 48]
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Percentage of Participants With Anti-Tocilizumab Antibody
[Time Frame: Baseline, and post-baseline (up to Week 48)]
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Secondary ID(s)
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2011-001460-22
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WA27788
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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