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Clinical Trials/EUCTR2011-001460-22-GB
EUCTR2011-001460-22-GB
Active, not recruiting
Phase 1

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 - N/A

F. Hoffmann-La Roche Ltd.0 sites87 target enrollmentOctober 17, 2011
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ConditionsSystemic Sclerosis (SSc)MedDRA version: 17.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsRoActemra

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Systemic Sclerosis (SSc)
Sponsor
F. Hoffmann-La Roche Ltd.
Enrollment
87
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2011
End Date
June 16, 2015
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Ability and willingness to give written informed consent and comply with the requirements of the study protocol
  • •Diagnosis of SSc, as defined using ACR criteria
  • •Disease duration of \= 60 months (defined as time from the first non\-Raynaud phenomenon manifestation)
  • •Age \= 18 years
  • •\= 15 and \= 40 mRSS units at the screening visit
  • •Uninvolved skin at injection sites
  • •Active disease
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Rheumatic autoimmune disease other than SSc, including but not limited to, RA, systemic lupus erythematosis, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren syndrome and eosinophilic myalgia syndrome
  • •Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
  • •History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • •Evidence of moderately severe concomitant nervous system, renal, endocrine or GI disease, as determined by the Principal Investigator
  • •Pulmonary disease with FVC \= 50% of predicted or a DLCO (hemoglobin corrected) \= 40% of predicted

Outcomes

Primary Outcomes

Not specified

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