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: 15 Sep 2017

At a glance

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

    • 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.
    • 15 Sep 2017 According to a Boehringer Ingelheim media release, based on the data from this trial the company has submitted The Marketing Authorisation Application (MAA) for BI 695501 for treatment of moderate to severely active rheumatoid arthritis. And, the CHMP of the EMA has adopted a positive opinion Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
    • 27 Jul 2017 According to a Boehringer Ingelheim media release, results were presented at the annual European Congress of Rheumatology.
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