Prospective Cohort Study of Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients in Europe (OBS12753)

Study identification

• EU PAS number:
  EUPAS19610
• Study ID:
  43828
• Official title and acronym:
  Prospective Cohort Study of Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients in Europe (OBS12753)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  France

  Italy

  Norway
• Study description:
  Teriflunomide is an immunomodulator with both anti proliferative and anti inflammatory activity that has shown to be effective in remitting-relapsing forms of Multiple Sclerosis (MS). In order to further evaluate the long-term risks of teriflunomide, a five year post-approval observational study is proposed to investigate the incidence of selected safety events and overall safety in patients treated with teriflunomide in Europe in real life.
• Study status:
  Finalised

Research institutions and networks

Institutions

International Prevention Research Institute (IPRI)

France

BELTRIMS (Belgian MS registry) Brussels, Belgium, Hospices Civils de Lyon (French Systeme National des données de Santé) Lyon, France, Danish MS Registry Copenhagen, Denmark, AIM-IMA (Belgian social security agencies) Brussels, Belgium

Study timelines

Date when funding contract was signed

Actual:15/10/2015

Study start date

Actual:26/08/2013

Date of final study report

Planned:31/12/2020

Actual:02/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

SANOFI

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)