A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs

Summary

To compare the PK profiles of HLX01 and Rituximab in Chinese patients with moderate to severe rheumatoid arthritis.

Timeline

Start

2016-02

Primary completion

2018-08

Completion

2018-08

Outcome

Met primary endpoint

release “Results of the study met defined primary and secondary endpoints, demonstrating equivalence of pharmacokinetic, safety and immunogenicity profiles” henlius.com ↗

Drugs

Indications