NCT03161457

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

A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: JHL Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will take place across approximately 31 centres across 12 countries and will randomise approximately 150 subjects as outpatients. The primary objective is to investigate and compare the pharmacokinetic profiles of JHL1101 and MabThera (rituximab). The secondary objectives are to investigate the safety, tolerability, and immunogenicity of JHL1101 versus MabThera, to investigate the pharmacodynamics profile of JHL1101 versus MabThera, and investigate the efficacy of JHL1101 versus MabThera.

Conditions

• Rheumatoid Arthritis
• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	JHL1101	1000 mg containing 10 mg/mL rituximab to be diluted to a concentration of 1 to 4 mg/mL in 0.9% normal saline or 5% D-glucose for administration
BIOLOGICAL	MabThera	1000 mg containing 10 mg/mL rituximab to be diluted to a concentration of 1 to 4 mg/mL in 0.9% normal saline or 5% D-glucose for administration

Timeline

• Start date: 2017-02-27
• Primary completion: 2019-04-16
• Completion: 2019-04-16
• First posted: 2017-05-19
• Last updated: 2020-01-09

Locations

32 sites across 11 countries: Bosnia and Herzegovina, Bulgaria, Czechia, Germany, Hungary, Lithuania, Poland, Russia, Taiwan, Ukraine, United Kingdom