JHL-CLIN-1101-01: JHL1101 versus MabThera in RA
Research type
Research Study
Full title
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 RA on Background MTX Therapy
IRAS ID
207428
Contact name
Hasan Tahir
Contact email
Sponsor organisation
JHL Biotech Inc
Eudract number
2015-005470-38
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Rheumatoid arthritis (RA) is a chronic inflammatory disorder that typically affects the lining of small joints in hands and feet. RA causes a painful swelling that can eventually result in bone erosion and joint deformity. If left untreated, RA may lead to severe functional disabilities, and therefore a considerable reduction in quality of life.
Traditionally, RA has been treated with a combination of anti-inflammatory agents and disease-modifying antirheumatic drugs (DMARDs). Therapeutic options have improved with the introduction of biologic DMARDs.
JHL1101 is a biosimilar, which means that it is very similar, but not identical, to an existing biological therapy MabThera® (rituximab injection, brand name MabThera® in the European Union [EU] or Rituxan® in the United States [US]). MabThera®, with another prescription medicine called methotrexate (MTX), has been shown to reduce the signs and symptoms of moderate to severe active RA that has not improved with other types of treatments. JHL1101 has comparable structural and functional attributes to MabThera® and should, therefore, show similar efficacy and safety. The purpose of this Phase I clinical study is to compare JHL1101 with MabThera® and to find out if it works in the same way in the treatment of moderate to severe RA. The study will also assess the safety, tolerability (likelihood of causing side effects), efficacy (if as good as the active drug) and immunogenicity (making anti-drug antibodies by immune response) of JHL1101. Biologic therapies are very expensive, which limits patient access; JHL1101 may improve access to treatment while delivering substantial cost savings.
Around 150 patients in 40 study centres in approximately 12 countries will take part in this study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1211
Date of REC Opinion
9 Aug 2016
REC opinion
Further Information Favourable Opinion