An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
NCT ID: NCT06053749
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
4 participants
OBSERVATIONAL
2024-03-20
2026-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
Avonex (IFNβ-1-a, Biogen Netherlands B.V)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Rebif (IFNβ-1-a, Merck Europe B.V.)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Extavia (IFNβ-1-b, Novartis Europharm Limited)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
MS disease modifying drugs (MSDMDs)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
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:
MS disease modifying drugs (MSDMDs)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Pregnancies exposed to IFNB only
With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy
Avonex (IFNβ-1-a, Biogen Netherlands B.V)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Rebif (IFNβ-1-a, Merck Europe B.V.)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Extavia (IFNβ-1-b, Novartis Europharm Limited)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Pregnancies unexposed to IFNB nor other MSDMDs
No dispensed IFNB nor any other MSDMDs during the pre-pregnancy period nor any time during pregnancy
No interventions assigned to this group
Interventions
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Avonex (IFNβ-1-a, Biogen Netherlands B.V)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Rebif (IFNβ-1-a, Merck Europe B.V.)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Extavia (IFNβ-1-b, Novartis Europharm Limited)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
MS disease modifying drugs (MSDMDs)
Information on drug use in hospitals and outpatient clinics are not recorded in the drug registers used in the study and, thus, information on exposure to these medications is not available.
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
64 Years
FEMALE
No
Sponsors
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Biogen Netherlands B.V
UNKNOWN
Novartis Europharm Limited
UNKNOWN
Merck Europe B.V.
UNKNOWN
Bayer
INDUSTRY
Responsible Party
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Locations
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Many locations
Multiple Locations, , Finland
Many locations
Multiple Locations, , Sweden
Countries
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Related Links
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Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Other Identifiers
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EUPAS38736
Identifier Type: OTHER
Identifier Source: secondary_id
21334
Identifier Type: -
Identifier Source: org_study_id