Study identification

PURI

https://redirect.ema.europa.eu/resource/48665

EU PAS number

EUPAS38736

Study ID

48665

Official title and acronym

INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden

DARWIN EU® study

No

Study countries

Finland
Sweden

Study description

Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy.
After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed.
However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a non-interventional drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022.
If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
InstitutionNon-Pharmaceutical companyENCePP partner

Contact details

Victoria Banks

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG, Biogen Netherlands B.V., Merck Europe, B.V. Novartis Europharm Limited
Study protocol
Initial protocol

INFORM Protocol_V2.1 03 November 2020_signed_redacted

English (4.58 MB - 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)