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A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.

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Trial Profile

A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Certolizumab pegol (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions
  • Acronyms RAPID-C OLE
  • Sponsors UCB Pharma SA

    • Most Recent Events

    • 22 Jul 2019 According to the UCB media release, the company has received an Import Drug License (IDL) from the National Medical Product Administration (NMPA) and approval of CIMZIA (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis, based on the data from ths study.
    • 30 Mar 2018 According to the UCB media release, based on the data from this study, company announced the submission of an application for an Import Drug License to the Chinese Food and Drug Administration for the approval of CIMZIA (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis.
    • 16 Jan 2017 Status changed from active, no longer recruiting to completed.
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