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A multi-center, randomized, double-blind,placebo-controlled study comparing 80 mg of adalimumab with placebo, and demonstrating the non-inferiority of monthly 80 mg adalimumab dosing compared with 40 mg adalimumab every other week dosing.

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Trial Profile

A multi-center, randomized, double-blind,placebo-controlled study comparing 80 mg of adalimumab with placebo, and demonstrating the non-inferiority of monthly 80 mg adalimumab dosing compared with 40 mg adalimumab every other week dosing.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Sponsors Abbott Laboratories

    • 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
    • 16 Jun 2018 Results of pooled analysis (DE009, DE011, DE019, M10-261 and M13-390) presented at the 19th Annual Congress of the European League Against Rheumatism
    • 23 Jun 2016 Results of safety analysis of this and other trials published in the Annals of the Rheumatic Diseases.

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