A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis

Sponsor
Tokyo University
Study ID
NCT04274257
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Autoimmune Diseases
  • Collagen Diseases
  • Lung Fibrosis
  • Scleroderma, Systemic
  • Skin Sclerosis

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Double-Blind Placebo — DRUG
    The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment. In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered.
  • Double-Blind Rituximab — DRUG
    The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment. In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered.

Study Details

This study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period.

Key Dates

Start date
Dec 4, 2017
Status verified
Feb 2020
Primary completion
May 9, 2019
Completion
Nov 5, 2019

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Double-Blind Placebo
    Participants will receive double-blind matching placebo from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48.
  • Experimental: Double-Blind Rituximab
    Participants will receive double-blind rituximab from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48.

Primary Outcome Measure

Change in Modified Rodnan Total Skin Thickness Score (mRTSS) during double-blind period [ Time Frame: From baseline to week 24 ]

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