Study identification

PURI

https://redirect.ema.europa.eu/resource/50627

EU PAS number

EUPAS49855

Study ID

50627

Official title and acronym

Evaluation of pregnancy and infant outcomes in Kesimpta patients using PRegnancy outcomes Intensive Monitoring (PRIM) data - The Kesimpta-PRIM study. (The Kesimpta PRIM study.)

DARWIN EU® study

No

Study countries

Switzerland

Study description

The Kesimpta PRIM study is a secondary use of data, non-interventional study (NIS) based on Novartis' pharmacovigilance (PV) system leveraging data collected via PRIM using a set of targeted checklists with structured follow-up on pregnancies spontaneously reported to the Novartis global safety database (Argus). Although pharmacovigilance data may be collected from any country in the world where the product is approved, the anonymized patient level data will be analyzed at a global level in Switzerland. All prospective and retrospective pregnancy cases reported to Novartis global safety database mentioning exposure to Kesimpta in multiple sclerosis (MS) patients will be considered for this study except cases reported as part of Kesimpta registry study (OMB157G2403). The primary analysis cohort of interest will be the prospectively reported pregnancies associated with maternal exposure during pregnancy up up to 180 days before last menstrual period. Retrospective pregnancy cases are defined as pregnancy cases with known pregnancy outcome or known abnormal findings obtained from a prenatal test at the time of initial reporting to Novartis. The study is descriptive in nature and will apply until a maximum of 10 years from marker authorization or until 500 prospectively reported live births with known status of malformations are assessed, whichever occurs first.

Study status

Ongoing
Research institution and networks

Institutions

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 interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis
Study protocol
Initial protocol

COMB157G2407_Protocol V1.1_Redacted

English (977.64 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)