Last updated on February 2017

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA)


Brief description of study

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA)

Detailed Study Description

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, PD, safety, efficacy, tolerability, and immunogenicity of SAIT101 versus MabThera® versus Rituxan® in patients with RA. This study will take place globally across approximately 70 study centers in order to randomize approximately 282 patients.
The study consists of Part A from baseline for PK and efficacy analysis, followed by Part B from Week 24 to 52 for safety follow-up that also collects transition data.

Clinical Study Identifier: TX147624

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Michelle Orzechowski

University of South Florida - Morsani Center for Advanced Healthcare
Tampa, FL USA
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