drugset / Trial / NCT06175338

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

NCT06175338 ↗

Phase 1 Active not recruiting 208 enrolled Mabscale, LLC
RandomizedParallel-groupTriple-blindOther

Summary

A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patients with rheumatoid arthritis.

Timeline

Start
2023-06-14
Primary completion
2024-11
Completion
2025-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1000 mg —

Indications