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A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2022

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At a glance

  • Drugs Methotrexate (Primary) ; Rituximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 10 Jun 2022 Results assessing efficacy and safety of HLX01 as combination therapy with methotrexate in Chinese patients with active rheumatoid arthritis who had inadequate responses to methotrexate, published in the Arthritis Research and Therapy.
  • 05 Jun 2021 Primary endpoint (American College of Rheumatology criteria (ACR) 20 response at week 24 (ACR20)) has been met as per results presented at the 22nd Annual Congress of the European League Against Rheumatism
  • 05 Jun 2021 Results presented at the 22nd Annual Congress of the European League Against Rheumatism

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