Multiple Sclerosis (MS)INFORMNCT06053749
An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
An observational study of Multiple Sclerosis (MS), run by Bayer at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 64 years, women only
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Avonex (IFNβ-1-a, Biogen Netherlands B.V), Rebif (IFNβ-1-a, Merck Europe B.V.) and Extavia (IFNβ-1-b, Novartis Europharm Limited)
- How many people
- 4 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Mar 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- Women only
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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)
Who cannot join
- None.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden
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.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Avonex (IFNβ-1-a, Biogen Netherlands B.V), Rebif (IFNβ-1-a, Merck Europe B.V.), Extavia (IFNβ-1-b, Novartis Europharm Limited), Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG), Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avonex (IFNβ-1-a, Biogen Netherlands B.V)Drug
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.)Drug
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)Drug
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)Drug
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)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies exposed to IFNB only | With dispensed IFNB, no other MS disease modifying drugs (MSDMDs) during the pre-pregnancy period or during pregnancy Receives: Drug: Avonex (IFNβ-1-a, Biogen Netherlands B.V); Drug: Rebif (IFNβ-1-a, Merck Europe B.V.); Drug: Extavia (IFNβ-1-b, Novartis Europharm Limited); Drug: Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG); Drug: Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V) | |
| 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 Receives: Drug: Avonex (IFNβ-1-a, Biogen Netherlands B.V); Drug: Rebif (IFNβ-1-a, Merck Europe B.V.); Drug: Extavia (IFNβ-1-b, Novartis Europharm Limited); Drug: Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG); Drug: Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V); Drug: MS disease modifying drugs (MSDMDs) | |
| 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: Receives: Drug: MS disease modifying drugs (MSDMDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
Analysis groups: Pregnancies exposed to IFNB only group and Pregnancies unexposed to IFNB nor other MSDMDs group
Measured: 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
Pre-defined adverse pregnancy outcomes:
- Anomalies: Major congenital anomalies (MCA); All anomalies, including minor and major
- Fatal outcomes: Spontaneous abortions, Elective terminations, Stillbirth and Neonatal mortality
- Growth outcomes: Small for gestation age and Low birth weight
- Other outcomes: Preterm birth
Late pregnancy, i.e. the 2nd and 3rd trimester.
Measured: 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
Analysis in Pregnancies exposed to IFNB only group.
Measured: Data recorded between 2015-2019 and 2020-2022.
Secondary outcomes (2)
The number of pregnancies of women with MS in Finland and Sweden in exposure groups allowing exposure to other MSDMDs
Analysis groups: Pregnancies exposed to IFNB (regardless of other MSDMDs) group and Pregnancies unexposed to IFNB (regardless of other MSDMDs) group
Measured: 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
Measured: Data recorded between 2015 to 2022 in Finland and Sweden
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Mar 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen Netherlands B.V, Novartis Europharm Limited, Merck Europe B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053749
- Sponsor's protocol ID
- 21334
- Other IDs
- EUPAS38736
- Acronym
- INFORM
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden
- ClinicalTrials.gov ID
- NCT06053749
- Acronym / sponsor ID
- INFORM / 21334
- Conditions
- Multiple Sclerosis (MS)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Biogen Netherlands B.V, Novartis Europharm Limited, Merck Europe B.V.
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnancies exposed to IFNB only | – | Drug: Avonex (IFNβ-1-a, Biogen Netherlands B.V), Drug: Rebif (IFNβ-1-a, Merck Europe B.V.), Drug: Extavia (IFNβ-1-b, Novartis Europharm Limited), Drug: Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG), Drug: Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V)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) | – | Drug: Avonex (IFNβ-1-a, Biogen Netherlands B.V), Drug: Rebif (IFNβ-1-a, Merck Europe B.V.), Drug: Extavia (IFNβ-1-b, Novartis Europharm Limited), Drug: Betaseron (IFN-β-1-b, BAY86-5046, Bayer AG), Drug: Plegridy (Peg IFNβ-1-a, Biogen Netherlands B.V), Drug: MS disease modifying drugs (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) | – | Drug: MS disease modifying drugs (MSDMDs)No dispensed IFNB during the pre-pregnancy period nor any time during pregnancy, regardless of other MSDMDs Outcomes: |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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. | Drug | 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. | Drug | 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. | Drug | 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. | Drug | 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. | Drug | Pregnancies exposed to IFNB (regardless of other MSDMDs), Pregnancies unexposed to IFNB (regardless of other MSDMDs) |
Primary outcome
The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
Time frame: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
Analysis groups: Pregnancies exposed to IFNB only group and Pregnancies unexposed to IFNB nor other MSDMDs group
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
Time frame: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.
Pre-defined adverse pregnancy outcomes: * Anomalies: Major congenital anomalies (MCA); All anomalies, including minor and major * Fatal outcomes: Spontaneous abortions, Elective terminations, Stillbirth and Neonatal mortality * Growth outcomes: Small for gestation age and Low birth weight * Other outcomes: Preterm birth Late pregnancy, i.e. the 2nd and 3rd trimester.
The annual number of pregnancies of women with MS in the exposure groups
Time frame: Data recorded between 2015-2019 and 2020-2022.
Analysis in Pregnancies exposed to IFNB only group.
2 secondary outcomes
The number of pregnancies of women with MS in Finland and Sweden in exposure groups allowing exposure to other MSDMDs
Time frame: 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
Time frame: Data recorded between 2015 to 2022 in Finland and Sweden
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS), run by Bayer at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of pregnancies of women with MS, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs) (time frame: Data recorded between 01 January 1996 - 31 December 2022 in Finland, and 01 July 2005 - 31 December 2022 in Sweden.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.