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
Latest Information Update: 05 Nov 2021
At a glance
- Drugs Rituximab (Primary)
- Indications Rheumatoid arthritis
- Focus Pharmacokinetics
- Sponsors Shanghai Henlius Biotech
- 17 Dec 2020 According to a Shanghai Henlius Biotech media release, this study supported the initiation of the following Phase 3 clinical study.
- 17 Dec 2020 According to a Shanghai Henlius Biotech media release, the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of its rituximab injection HLX01 to treat rheumatoid arthritis (RA).The new drug application (NDA) of HLX01 (rituximab injection) for RA is based on results from the Phase 1 clinical study (HLX01-RA01) and Phase 3 clinical study (HLX01-RA03).
- 15 Jun 2019 Results presented at the 20th Annual Congress of the European League Against Rheumatism