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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Tabalumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms FLEX-O
  • Sponsors Eli Lilly and Company

    • Most Recent Events

    • 17 Mar 2020 Results (n=978) of retrospective, observational analysis from seven rheumatoid arthritis clinical studies: H9BMCBCDM, H9BMCBCDO, H9BMCBCDV, IM126004, IM119015, IM101029, M10261 geographical information (from Asia, Latin America, RFEE, USA, and Western Europe) assessing regional differences in adverse event rates and disease activity were published in the Rheumatology
    • 01 Aug 2015 Results published in the JCR: Journal of Clinical Rheumatology.
    • 30 Oct 2013 Primary endpoint 'American-College-of-Rheumatology-20%-response-criteria' has not been met according to results presented at the 77th American College of Rheumatology and the 48th Annual Meeting of the Association of Rheumatology and Health Professionals.
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