NCT03355872View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Rheumatoid Arthritis
Interventions
DRUG

HLX01

Biosimilar of Rituximab

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY

NCT03355872 - 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 | Biotech Hunter | Biotech Hunter