drugset / Trial / NCT02819726

PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis

NCT02819726 ↗

Phase 1 Completed 294 enrolled Archigen Biotech Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomised, double blind, parallel group, multicentre study yo compare the pharmacokinetics, pharmacokinetics, safety and efficacy of SAIT101 versus MabThera® versus Rituxan® in patients with rheumatoid arthritis.

Timeline

Start
2016-10-11
Primary completion
2018-04-30
Completion
2018-11-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 1000 mg Intravenous
Subject SAIT101 Unknown 1000 mg Intravenous

Indications