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Clinical trial

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

ID
Name
21334
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 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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2026-03-31
Trial end
2026-03-31
Status
Not yet recruiting
Treatment
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.
Arms:
Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies exposed to IFNB only
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.
Arms:
Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies exposed to IFNB only
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.
Arms:
Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies exposed to IFNB only
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.
Arms:
Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies exposed to IFNB only
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.
Arms:
Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies exposed to IFNB only
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.
Arms:
Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies unexposed to IFNB (regardless of other MSDMDs)
Size
100
Primary endpoint
The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
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
Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
The annual number of pregnancies of women with MS in the exposure groups
Data recorded between 2015-2019 and 2020-2022.
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-22

1 organization

6 products

1 indication

Organization
Bayer
Product
Avonex
Indication
Multiple Sclerosis
Product
Rebif
Product
Extavia
Product
Betaseron
Product
Plegridy
Product
MS disease modifying drugs