Clinical trial NCT06053749: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
Official title: INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis (MS)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Biogen Netherlands B.V
name: Novartis Europharm Limited
name: Merck Europe B.V.
First posted: 2023-09-26
Enrollment: 4
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aggregate secondary data will be collected from the following national registers in Finland and Sweden.

FINLAND: Medical Birth Register (MBR-Fin), Care Register for Health Care, National Reimbursement Register/National Prescription Register, Register of Induced Abortions.

SWEDEN: Medical Birth Register (MBR-Swe), National Patient Register (NPR), Swedish Prescribed Drug Register (SPDR).

Brief summary: 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 secondary use of data 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.


Eligibility criteria: Inclusion Criteria:

* Women with a diagnosis of MS disease, regardless of MS clinical type, recorded at least once during the full study period.
* Women with at least one recorded pregnancy after the MS diagnosis (including pregnancies ending in live birth, stillbirth, spontaneous abortion, ectopic pregnancy, or elective termination)

Exclusion Criteria:

- None.

Primary outcomes:
measure: The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
timeFrame: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
measure: The level of precision for the risk of pre-defined adverse pregnancy outcomes in late pregnancy that can be obtained with the available number of exposed and unexposed pregnancies
timeFrame: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
measure: The annual number of pregnancies of women with MS in the exposure groups
timeFrame: Data recorded between 2015-2019 and 2020-2022.
Secondary outcomes:
measure: The number of pregnancies of women with MS in Finland and Sweden in exposure groups allowing exposure to other MSDMDs
timeFrame: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
measure: The annual number of women with MS in childbearing age, and with dispensed IFNB
timeFrame: Data recorded between 2015 to 2022 in Finland and Sweden
Other outcomes:
Locations:
city: Multiple Locations
country: Finland
facility: Many locations
city: Multiple Locations
country: Sweden
facility: Many locations
Study officials:
References: