Study identification

PURI

https://redirect.ema.europa.eu/resource/43835

EU PAS number

EUPAS41495

Study ID

43835

Official title and acronym

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated with Mayzent (siponimod): An OTIS Observational Pregnancy Surveillance Study

DARWIN EU® study

No

Study countries

Canada
United States

Study description

The study aims to evaluate risk of adverse pregnancy or infant outcomes in patients exposed to Mayzent/siponimod therapy during pregnancy. This study will utilize a prospective, observational, exposure cohort design and conducted by the Organization of Teratology Information Specialists (OTIS) Research Group, a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout North America. The primary objective is to estimate and compare the prevalence of major structural defects in siponimod exposed pregnant women versus 1) disease-matched pregnant women not exposed to siponimod, and 2) healthy pregnant women.

Study status

Ongoing
Research institutions and networks

Institutions

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 Pharmaceuticals
Study protocol
Initial protocol

BAF312A2403 - final draft 3 protocol - for submission - Clean version_Redacted

English (1.05 MB - PDF)View document
Updated protocol

BAF312A2403 - final protocol V1.1 - for submission - Clean_Redacted

English (940.31 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only