EPID Multiple Sclerosis Pregnancy Study

Multiple Sclerosis Clinical Trial

Official title:

Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749396
• Other study ID #: 18219
• Status: Completed
• Start date: May 2, 2016
• Est. completion date: August 14, 2018

Study information

• Verified date: August 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

i) FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR:

1 January 2004 - 31 December 2014.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2089
• Est. completion date: August 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
• Extavia (interferon beta-1b), Novartis Pharma AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
• Rebif (interferon beta-1a), Merck Serono Europe Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
• Plegridy (peginterferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
• Avonex (interferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
• MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Other:
• No MSDMDs therapy (control)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

Locations

Country	Name	City	State
Finland	Many locations	Multiple Locations

Sponsors (5)

Lead Sponsor	Collaborator
Bayer	Biogen, EPID Research, Merck Serono Europe Ltd, Novartis Pharmaceuticals

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse pregnancy outcome due to different regimes of IFN-ß 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-ß only Cohort 2: All patients with IFN-ß 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-ß exposure regardless of exposure to other MSDMDs	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Elective TOPFA for other reasons than IFN-ß exposure	Cohort 1: Exposure to IFN-ß only Cohort 2: All patients with IFN-ß 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-ß exposure regardless of exposure to other MSDMDs	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Elective termination for other reasonsthan IFN-ß exposure	Cohort 1: Exposure to IFN-ß only Cohort 2: All patients with IFN-ß 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-ß exposure regardless of exposure to other MSDMDs	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Stillbirth due to different regimes of IFN-ß exposure	Cohort 1: Exposure to IFN-ß only Cohort 2: All patients with IFN-ß 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-ß exposure regardless of exposure to other MSDMDs	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Live birth while different regimes of IFN-ß exposure	Cohort 1: Exposure to IFN-ß only Cohort 2: All patients with IFN-ß 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-ß exposure regardless of exposure to other MSDMDs	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	MCA due to different regimes of IFN-ß exposure	Cohort 1: Exposure to IFN-ß only Cohort 2: All patients with IFN-ß 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-ß exposure regardless of exposure to other MSDMDs	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-ß exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Comparison of the prevalence of stillbirth due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Comparison of the prevalence of live birth due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Comparison of the prevalence of MCA due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Primary	Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3),; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4); Women with MS exposed to IFN-ß regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-ß exposure	Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to any MSDMDs (cohort 3),; Women with MS exposed to IFN-ß only (cohort 1) vs. unexposed to IFN-ß regardless of exposure to other MSDMDs (cohort 4); Women with MS exposed to IFN-ß regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	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	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	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	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	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	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	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	Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary	Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-ß 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	Retrospective Data analysis: MS patients data encompassing approximately 19 years

External Links

•   Click here to find results for studies related to Bayer products.