A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

Roche

Status and phase

Completed

Phase 3

Conditions

Sclerosis, Systemic

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01532869

2011-001460-22 (EudraCT Number)

WA27788

Details and patient eligibility

About

This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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