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: 13 Nov 2017

At a glance

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

    • 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.
    • 06 Nov 2017 According to a Boehringer Ingelheim Pharmaceuticals media release, 48-week data will be presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting 2017.
    • 15 Sep 2017 The decision of the European Commission on the approval is expected in the fourth quarter of 2017, as reported in a Boehringer Ingelheim media release.
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