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Multi-center, randomized, double-blind, parallel, positive drug control, comparison of domestic recombinant anti-TNF-a whole-human monoclonal antibody injection (HS016) and original drug Xiulai? subcutaneous injection for active ankylosing spondylitis Phase III clinical trials for efficacy and safety

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Trial Profile

Multi-center, randomized, double-blind, parallel, positive drug control, comparison of domestic recombinant anti-TNF-a whole-human monoclonal antibody injection (HS016) and original drug Xiulai? subcutaneous injection for active ankylosing spondylitis Phase III clinical trials for efficacy and safety

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Mar 2022

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis
  • Focus Pharmacokinetics; Registrational; Therapeutic Use

Most Recent Events

  • 01 Mar 2022 Results comparing the efficacy of HS016 and adalimumab in stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires, published in the Clinical Rheumatology
  • 20 Feb 2020 Results comparing safety and efficacy of adalimumab (Humira) and the adalimumab biosimilar candidate (HS016) in chinese patients with active ankylosing spondylitis, published in the BioDrugs.
  • 03 Oct 2019 New trial record

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