NCT04274257

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

Double-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic Sclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Tokyo University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Double-Blind Placebo	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.
DRUG	Double-Blind Rituximab	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.

Timeline

• Start date: 2017-12-04
• Primary completion: 2019-05-09
• Completion: 2019-11-05
• First posted: 2020-02-18
• Last updated: 2020-02-18

Locations

4 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study