Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated with Kesimpta (ofatumumab) using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry (Kesimpta Pregnancy Registry)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49804
• EU PAS number:
  EUPAS49803
• Study ID:
  49804
• Official title and acronym:
  Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated with Kesimpta (ofatumumab) using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry (Kesimpta Pregnancy Registry)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Germany

  United States
• Study description:
  The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS. The study is expected to enroll for approximately 7 years and follow the pregnant women and their infant(s) over a maximum of 21 months. The primary objective is to estimate and compare the prevalence of major structural defects in fetuses/infants born to Kesimpta exposed pregnant women with MS versus 1) disease-matched pregnant women not exposed to Kesimpta, and 2) healthy pregnant women. The study will be conducted as two sub-studies, namely the Kesimpta-OTIS sub-study and the Kesimpta-DMSKW sub-study, identical in design, run in parallel aiming to combine (meta-analyze) the results obtained from these two sub-studies. Other outcomes of interest include: a pattern of minor structural defects, spontaneous abortion, stillbirth, elective termination, preterm delivery, preeclampsia/eclampsia, small for gestational age infants, and small for age for postnatal growth at one year of age, developmental performance at approximately one year of age, and serious or opportunistic infections in the first year of life.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW), Germany

Networks

Organization of Teratology Information Specialists (OTIS) Network

Study timelines

Date when funding contract was signed

Planned: 18/03/2021

Actual: 18/03/2021

Study start date

Planned: 31/01/2023

Actual: 05/01/2023

Data analysis start date

Planned: 28/02/2033

Date of final study report

Planned: 28/02/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Study protocol

Initial protocol

OMB157G2403 (main) - final protocol V1.0 - for submission_Redacted

Regulatory

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

Other study registration identification numbers and links

FDA/PMR 3901-2, COMB157G2403