An International Teriflunomide Pregnancy Exposure Registry

• Research type

  Research Study

• Full title

  An International Pregnancy Exposure registry of Women With Multiple Sclerosis (MS) exposed to Teriflunomide

• IRAS ID

  161741

• Contact name

  David Rog

• Contact email

  David.rog@srft.nhs.uk

• Sponsor organisation

  Sanofi Aventis R&D (Genzyme Corporation)

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This is an international pregnancy exposure registry of women with multiple sclerosis (MS) exposed to at least one dose of teriflunomide during pregnancy. There will be no interventional procedures to be done to the participants.
  
  The conduct of this registry in no way recommends that patients receiving teriflunomide become pregnant, but serves only to observe and document exposures that do occur, and to collect information on the pregnancy outcome and infant follow­ up to approximately one year of age.

  The design of the study will mirror real life management of the participants. There is no fixed study visit schedule. The visits will be completed in accordance with clinical practice. However, the participants’ Health Care Providers (HCPs) will be asked to record data for study endpoint assessments at four time points. First data recording is at the time of enrollment (ie, registration), second is at mid­pregnancy (approximately), third is at the completion of pregnancy, and fourth and the last is at approximately one year of age for the infants. Multiple Health Care Providers (HCPs), such as obstetric, neurologic, paediatric, general practitioner, may be asked to report on an individual.

  For each female participant and her child, the study participation is up to one year and nine months.

  This registry plans to collect information on birth defects, pregnancy outcomes, and infant characteristics including prematurity and serious adverse outcomes observed during the first year of life. The birth defect rate will be compared to the published birth defect rates.

  National Co-ordinating Investigator (NCI) will be in charge of raising awareness for the registry and collecting registry data through health care providers (HCPs). All collected data will be coded by the National Coordinator to protect data privacy prior to sending data forms to the Sponsor’s representative for review and processing.

• REC name

  West of Scotland REC 5

• REC reference

  15/WS/0018

• Date of REC Opinion

  22 Jan 2015

• REC opinion

  Favourable Opinion