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Clinical Trials/EUCTR2011-001460-22-DE
EUCTR2011-001460-22-DE
Active, not recruiting
Not Applicable

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 sites86 target enrollmentOctober 20, 2011
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ConditionsSystemic Sclerosis (SSc)MedDRA version: 18.1Level: PTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsRoActemra

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Sclerosis (SSc)
Sponsor
F. Hoffmann-La Roche Ltd.
Enrollment
86
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 20, 2011
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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