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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 4, 2017

Primary Completion Date

May 9, 2019

Study Completion Date

November 5, 2019

Conditions
Scleroderma, SystemicSkin SclerosisLung FibrosisAutoimmune DiseasesCollagen Diseases
Interventions
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."

Trial Locations (4)

Unknown

University of Fukui Hospital, Fukui

Chukyo Hospital, Nagoya

University of Tsukuba Hospital, Tsukuba

113-8655

The University of Tokyo Hospital, Tokyo

All Listed Sponsors
collaborator

Japan Agency for Medical Research and Development

OTHER_GOV

collaborator

Zenyaku Kogyo Co., Ltd.

INDUSTRY

lead

Tokyo University

OTHER

NCT04274257 - A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis | Biotech Hunter | Biotech Hunter