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

Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW), Germany

Networks

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
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

English (1.29 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable