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

Plain English Summary

An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden is a Not Applicable clinical trial sponsored by Bayer studying Multiple Sclerosis (MS). This study looks at how often pregnant women with Multiple Sclerosis (MS) in Finland and Sweden are exposed to interferon-beta (IFNB) during their second and third trimesters. It is for women diagnosed with MS who have been pregnant. This is an observational study, meaning researchers will review existing health records. No new treatments are given, and participants do not need to do anything extra. The alternative is to rely on existing, but limited, data on IFNB use during late pregnancy. The trial aims to enroll 4 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women diagnosed with MS, regardless of the type of MS. Women who have had at least one pregnancy after their MS diagnosis. There are no exclusion criteria, meaning anyone meeting the inclusion criteria can be part of the study. Age and specific health requirements beyond having MS and a pregnancy are not specified as the study uses existing records. This trial is studying Multiple Sclerosis (MS), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures will tell us how many pregnant women with MS were exposed to interferon-beta in their second and third trimesters, and how precise the data is for future studies on pregna The specific primary outcome measures are: 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.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to gather more information on the use of interferon-beta during the later stages of pregnancy for women with MS, addressing a gap in current knowledge. This research targets Multiple Sclerosis (MS), where improved treatment options are needed.

Investor Insight

This study is a drug utilization study by Bayer, focusing on understanding the real-world use of interferon-beta in a specific patient population, which could inform future research and market strateg

Is This Trial Right for Me?

Ask your doctor if interferon-beta is a treatment option for your MS and how it might be used during pregnancy. Since this is an observational study using existing records, your day-to-day participation involves no extra steps. The study will review your past medical history related to MS and pregnancy. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 4 participants

Interventions

• DRUG: 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.
• DRUG: 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.
• DRUG: 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.
• DRUG: 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.
• DRUG: 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.

Primary Outcomes

• 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.)

Secondary Outcomes

• The number of pregnancies of women with MS in Finland and Sweden in exposure groups allowing exposure to other MSDMDs (Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.)
• The annual number of women with MS in childbearing age, and with dispensed IFNB (Data recorded between 2015 to 2022 in Finland and Sweden)

Full 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.

Trial Locations

• Many locations, Multiple Locations, Finland
• Many locations, Multiple Locations, Sweden

Frequently Asked Questions

Related Conditions

• Multiple Sclerosis (MS)
• Neurology
• Pregnancy
• Autoimmune Diseases
• Women's Health
• Drug Utilization Studies
• Pharmacovigilance
• Interferon Therapy
• Biologics
• Chronic Disease Management

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