Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project (OBS13499)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41601
• EU PAS number:
  EUPAS17065
• Study ID:
  41601
• Official title and acronym:
  Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project (OBS13499)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  This is a North American prospective, observational, exposure cohort study of pregnancy outcomes in women with multiple sclerosis (MS) who are exposed to teriflunomide during pregnancy. The outcomes in women exposed to teriflunomide will be compared to those observed in two comparison groups: one in women with MS who have not been exposed to teriflunomide during pregnancy, and the other in women without MS.
• Study status:
  Finalised

Research institution and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

Study timelines

Date when funding contract was signed

Actual: 12/02/2013

Study start date

Actual: 25/04/2013

Date of final study report

Planned: 29/03/2024

Actual: 22/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

rdct-obs13499-protocol.pdf

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)