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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Rituximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Shanghai Henlius Biotech
  • Most Recent Events

    • 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
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