Immunotherapy of the Recent-onset Type 1 Diabetes in Adolescents With Repeated Courses of Rituximab

PHASE2RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

April 19, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

March 31, 2028

Conditions
Diabetes Mellitus, Type 1
Interventions
BIOLOGICAL

rituximab

"Rituximab will be administered intravenously in three courses. The 1st course (loading dose) will include six rituximab infusions on days 1, 3, 5, 8, 14, and 21 of the study. On days 1, 3, and 5 rituximab will be infused at doses of 50, 125, and 200 mg per m2 of the participant's body surface area, respectively. On days 8, 14, and 21 rituximab will be infused at doses of 375 mg/m2, but not more than 500 mg total dose.~The 2nd course (maintenance therapy) will include four rituximab infusions on days 63, 70, 77, and 85 at doses of 375 mg/m2, but not more than 500 mg total dose.~The 3rd course (maintenance therapy) will include four rituximab infusions on days 119, 126, 134, and 140 at doses of 375 mg/m2, but not more than 500 mg total dose"

Trial Locations (2)

Unknown

RECRUITING

I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow

RECRUITING

Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University, Moscow

All Listed Sponsors
lead

Pirogov Russian National Research Medical University

OTHER