Multiple SclerosisNCT02749396
EPID Multiple Sclerosis Pregnancy Study
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Finland.
Trial summary
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG, Extavia (interferon beta-1b), Novartis Pharma AG and Rebif (interferon beta-1a), Merck Serono Europe Ltd
- How many people
- 2,089 participants
- Where
- 1 siteFinland
- Study dates
- 2 May 2016to 14 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The target study population consists of Finnish, Swedish and Norwegian women diagnosed with MS who have been pregnant during the study period from 1996 to 2014. The pregnancy may have resulted in an induced abortion, spontaneous abortion, ectopic pregnancy, stillbirth, or live birth during the study period.
Who may be able to join
- Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
Read the detailed description
Information will be obtained from the Drugs and Pregnancy Project database (DPP - FIN) and the Medical Birth Register (MBR - SWE, NOR). The Finnish DPP and Norwegian MBR include information on all stillbirths of foetuses with a birth weight of at least 500 g or with a gestational age of at least 22+0 Gestational Week (GW). The Swedish MBR includes data on stillbirths after 28 GW
The estimated number of pregnancies in MS patients needed is 1671, encompassing data from:
- FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR: 1 January 2004 - 31 December 2014.
- Conditions
- Multiple Sclerosis
- Being tested
- Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG, Extavia (interferon beta-1b), Novartis Pharma AG, Rebif (interferon beta-1a), Merck Serono Europe Ltd, Plegridy (peginterferon beta-1a), Biogen Idec Ltd, Avonex (interferon beta-1a), Biogen Idec Ltd
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AGDrug
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Extavia (interferon beta-1b), Novartis Pharma AGDrug
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Rebif (interferon beta-1a), Merck Serono Europe LtdDrug
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Plegridy (peginterferon beta-1a), Biogen Idec LtdDrug
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Avonex (interferon beta-1a), Biogen Idec LtdDrug
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)Drug
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
No MSDMDs therapy (control)Other
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
| Study group | Role | What they receive |
|---|---|---|
| IFN-β / Cohort 1 | Exposure to IFN-β only Receives: Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG; Drug: Extavia (interferon beta-1b), Novartis Pharma AG; Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd; Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd; Drug: Avonex (interferon beta-1a), Biogen Idec Ltd | |
| IFN-β + other MSDMDs / Cohort 2 | Women with MS exposed to IFN-β regardless of exposure to other MSDMDs Receives: Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG; Drug: Extavia (interferon beta-1b), Novartis Pharma AG; Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd; Drug: Avonex (interferon beta-1a), Biogen Idec Ltd; Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) | |
| No MSDMDs / Cohort 3 | Women with MS exposed with no exposure to any MSDMDs Receives: Other: No MSDMDs therapy (control) | |
| No IFN-β + other MSDMDs / Cohort 4 | Women with MS exposed to IFN-β exposure regardless of exposure to other MSDMDs Receives: Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) | |
| Other MSDMDs / Cohort 5 | Women with MS exposed to other MSDMD only excluding IFN-β or glatiramer acetate (Copaxone) or dimethyl fumarate (Tecfidera) Receives: Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046) | |
| Control / Cohort 6 | Women from the general population without MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Elective TOPFA for other reasons than IFN-β exposure
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Elective termination for other reasonsthan IFN-β exposure
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Stillbirth due to different regimes of IFN-β exposure
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Live birth while different regimes of IFN-β exposure
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
MCA due to different regimes of IFN-β exposure
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of live birth due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of MCA due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary outcomes (7)
Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3),
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
- Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3),
- Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
- Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of elective TOPFA stratified by specific patient characteristics
Patient characteristics:
country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of stillbirth stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of live birth stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of MCA stratified by specific patient characteristics
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure
Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn
Measured: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start2 May 2016
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Retrospective
- Enrolment
- 2,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EPID Research, Biogen, Merck Serono Europe Ltd, Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749396
- Sponsor's protocol ID
- 18219
- Status last verified
- Aug 2019
- First submitted
- 20 Apr 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
- ClinicalTrials.gov ID
- NCT02749396
- Acronym / sponsor ID
- 18219
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,089 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- EPID Research, Biogen, Merck Serono Europe Ltd, Novartis Pharmaceuticals
- Study start
- 2 May 2016 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
Detailed description
Information will be obtained from the Drugs and Pregnancy Project database (DPP - FIN) and the Medical Birth Register (MBR - SWE, NOR). The Finnish DPP and Norwegian MBR include information on all stillbirths of foetuses with a birth weight of at least 500 g or with a gestational age of at least 22+0 Gestational Week (GW). The Swedish MBR includes data on stillbirths after 28 GW
The estimated number of pregnancies in MS patients needed is 1671, encompassing data from:
- FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR: 1 January 2004 - 31 December 2014.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IFN-β / Cohort 1 | – | Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG, Drug: Extavia (interferon beta-1b), Novartis Pharma AG, Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd, Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd, Drug: Avonex (interferon beta-1a), Biogen Idec LtdExposure to IFN-β only |
| IFN-β + other MSDMDs / Cohort 2 | – | Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG, Drug: Extavia (interferon beta-1b), Novartis Pharma AG, Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd, Drug: Avonex (interferon beta-1a), Biogen Idec Ltd, Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)Women with MS exposed to IFN-β regardless of exposure to other MSDMDs |
| No MSDMDs / Cohort 3 | – | Other: No MSDMDs therapy (control)Women with MS exposed with no exposure to any MSDMDs |
| No IFN-β + other MSDMDs / Cohort 4 | – | Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)Women with MS exposed to IFN-β exposure regardless of exposure to other MSDMDs |
| Other MSDMDs / Cohort 5 | – | Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)Women with MS exposed to other MSDMD only excluding IFN-β or glatiramer acetate (Copaxone) or dimethyl fumarate (Tecfidera) |
| Control / Cohort 6 | – | –Women from the general population without MS |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target study population consists of Finnish, Swedish and Norwegian women diagnosed with MS who have been pregnant during the study period from 1996 to 2014. The pregnancy may have resulted in an induced abortion, spontaneous abortion, ectopic pregnancy, stillbirth, or live birth during the study period.
Key inclusion criteria (1 listed)
- Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AGInformation will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Drug | IFN-β + other MSDMDs / Cohort 2, IFN-β / Cohort 1 |
| Extavia (interferon beta-1b), Novartis Pharma AGInformation will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Drug | IFN-β + other MSDMDs / Cohort 2, IFN-β / Cohort 1 |
| Rebif (interferon beta-1a), Merck Serono Europe LtdInformation will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Drug | IFN-β + other MSDMDs / Cohort 2, IFN-β / Cohort 1 |
| Plegridy (peginterferon beta-1a), Biogen Idec LtdInformation will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Drug | IFN-β / Cohort 1 |
| Avonex (interferon beta-1a), Biogen Idec LtdInformation will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Drug | IFN-β + other MSDMDs / Cohort 2, IFN-β / Cohort 1 |
| MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Drug | IFN-β + other MSDMDs / Cohort 2, No IFN-β + other MSDMDs / Cohort 4, Other MSDMDs / Cohort 5 |
| No MSDMDs therapy (control)Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR) | Other | No MSDMDs / Cohort 3 |
Primary outcome
Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Elective TOPFA for other reasons than IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Elective termination for other reasonsthan IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Stillbirth due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Live birth while different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
MCA due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs
Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of live birth due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of MCA due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)
7 secondary outcomes
Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of elective TOPFA stratified by specific patient characteristics
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of stillbirth stratified by specific patient characteristics
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of live birth stratified by specific patient characteristics
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Prevalence of MCA stratified by specific patient characteristics
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure
Time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Finland.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth (time frame: Retrospective Data analysis: MS patients data encompassing approximately 19 years). The study lists 12 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 14 Aug 2019.