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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  AUBAGIO
• Study drug International non-proprietary name (INN) or common name:
  TERIFLUNOMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA31) teriflunomide
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  325

Study design details

• Main study objective:
  To assess pregnancy outcomes in women with multiple sclerosis (MS) who are exposed to teriflunomide during pregnancy.
• Outcomes:
  To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies. To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.
• Data analysis plan:
  Comparison of the pregnancy outcomes in women exposed to teriflunomide for the treatment of MS, with those observed in women with MS who have not been exposed to teriflunomide during pregnancy, and to the pregnancy outcomes of women without MS.

Documents

Study report

rdct-obs13499-addendum to interim report 10.pdf