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
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
- 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.