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A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

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Trial Profile

A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Iguratimod (Primary) ; Methotrexate (Primary)
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Acronyms SMILE
  • Sponsors Jiangsu Simcere Pharmaceutical

    • Most Recent Events

    • 05 Jun 2021 Primary endpoint (Change from baseline in modified Total Sharp Score (mTSS)) has been met as per results presented at the 22nd Annual Congress of the European League Against Rheumatism
    • 05 Jun 2021 Primary endpoint (Percentage of patients with ACR 20 response) 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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