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An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	12 Years - 64 Years
Gender	Female

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06053749
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bayer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries	Finland, Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis (MS)
Study Website:	View Trial Website

Arms & Interventions

Arms

: Pregnancies exposed to IFNB only

With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy

: Pregnancies unexposed to IFNB nor other MSDMDs

No dispensed IFNB nor any other MSDMDs during the pre-pregnancy period nor any time during pregnancy

: Pregnancies exposed to IFNB (regardless of other MSDMDs)

With dispensed IFNB, regardless of other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy

: Pregnancies unexposed to IFNB (regardless of other MSDMDs)

No dispensed IFNB during the pre-pregnancy period nor any time during pregnancy, regardless of other MSDMDs Outcomes: