Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36418
• EU PAS number:
  EUPAS36417
• Study ID:
  36418
• Official title and acronym:
  Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  The Apremilast Pregnancy Exposure Registry (Registry) is a United States (U.S.) based registry designed to monitor planned or unplanned pregnancies exposed to apremilast when used to treat an approved indication in accordance with the current approved prescribing information, who reside in the U.S. or Canada. The goal of the Registry is to conduct an observational, controlled prospective cohort study that will involve follow-up of live born infants to one year of age. The study population includes pregnant women who reside in the U.S. or Canada who have or have not used apremilast for any length of time in pregnancy for an approved indication. The cohort study target sample size is 100 pregnant women in each of three groups: • 100 women who have been exposed to apremilast in pregnancy for an approved indication.• 100 women with an approved disease who have not been exposed to apremilast at any time in pregnancy (primary comparison group).• 100 healthy women who have no diagnosis of an approved indication or other chronic illness and have not taken apremilast in pregnancy.The primary objective of the Registry is to evaluate any potential increase in the risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies. Secondary objectives are to evaluate the potential effect of exposure relative to the secondary comparison group of healthy pregnant women, and the effect of exposure on other adverse pregnancy outcomes including spontaneous abortion or stillbirth, preterm delivery, reduced infant birth size, a pattern of minor malformations, postnatal growth of live born children to one year of age, and incidence of serious or opportunistic infections or malignancies in live born children up to one year of age.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

MotherToBaby

Networks

Organization of Teratology Information Specialists (OTIS) Network

Study timelines

Date when funding contract was signed

Actual: 25/09/2014

Study start date

Actual: 12/12/2014

Data analysis start date

Planned: 01/03/2023

Date of final study report

Planned: 01/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen (Previously Celgene)

Study protocol

Initial protocol

Apremilast Pregnancy Registry Final Protocol 11July2014

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable