Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

June 14, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

April 30, 2025

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Rituximab

Rituximab 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml)

DRUG

MabThera®

MabThera® 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml)

Trial Locations (12)

Unknown

Immanuel Kant Baltic Federal University, Kaliningrad

Scientific-Research Medical Complex Your Health, Kazan'

"LLC Medical Center Revma-Med", Kemerovo

"LLC Korolev Family Clinic №4", Korolyov

Moscow City Clinical Hospital №1, Moscow

V.A. Nasonova Research Institute of Rheumatology, Moscow

Orenburg State Medical University, Orenburg

"JSC Northwestern Center for Evidence-Based Medicine", Saint Petersburg

"LLC Interleukin", Saint Petersburg

"Medical center Capital-Polis", Saint Petersburg

Saratov State Medical University, Saratov

"LLC Biomed", Vladimir

All Listed Sponsors
lead

Mabscale, LLC

INDUSTRY