A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis

Summary

This is a multicentre, randomised, double-blind, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance or documented active disease despite at least 12 weeks treatment according to the TNF inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.

Timeline

Start

2017-02-27

Primary completion

2019-04-16

Completion

2019-04-16

Outcome

Outcome not reported

Stopped (Business): “The development was stopped due to company's strategy consideration”

Drugs

Indications