Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial

Trial Profile

Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2018

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms VOLTAIRE-RA
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 07 Mar 2018 Results assessing clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira, were published in the Annals of the Rheumatic Diseases.
    • 13 Nov 2017 According to a Boehringer Ingelheim media release, the European Commission has granted Marketing Authorisation Application to Cyltezo (adalimumab biosimilar), for treatment of multiple chronic inflammatory diseases in adults and children.
    • 08 Nov 2017 Results assessing the long-term safety, efficacy and immunogenicity data from this study, were presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
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