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

Conditions

• Sclerosis, Systemic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Subcutaneously weekly, Weeks 0-48
• tocilizumab [RoActemra/Actemra] — DRUG
  162 mg subcutaneously weekly, Weeks 0-48
• tocilizumab [RoActemra/Actemra] — DRUG
  162 mg subcutaneously weekly, Week 48-96

Study Details

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.

Key Dates

Start date

Mar 31, 2012

Status verified

Aug 2016

Primary completion

Jan 31, 2014

Completion

Aug 31, 2015

Study Design

Enrollment

87 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
• Experimental: Tocilizumab

Primary Outcome Measure

Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (21)