NCT02749396

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,089

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

May 2, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

April 20, 2016

Last Update Submit

August 12, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (12)

  • 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

    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

    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

    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

    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

    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

    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

    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)

    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

    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)

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure

    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)

    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

    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)

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Comparison of the prevalence of MCA due to different regimes of IFN-β exposure

    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)

    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

    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)

    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

    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

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of elective TOPFA stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of stillbirth stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • Prevalence of live birth stratified by specific patient characteristics

    Retrospective Data analysis: MS patients data encompassing approximately 19 years

  • +2 more secondary outcomes

Study Arms (6)

IFN-β / Cohort 1

Exposure to IFN-β only

Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AGDrug: Extavia (interferon beta-1b), Novartis Pharma AGDrug: Rebif (interferon beta-1a), Merck Serono Europe LtdDrug: Plegridy (peginterferon beta-1a), Biogen Idec LtdDrug: 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

Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AGDrug: Extavia (interferon beta-1b), Novartis Pharma AGDrug: Rebif (interferon beta-1a), Merck Serono Europe LtdDrug: Avonex (interferon beta-1a), Biogen Idec LtdDrug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)

No MSDMDs / Cohort 3

Women with MS exposed with no exposure to any MSDMDs

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

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)

Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)

Control / Cohort 6

Women from the general population without MS

Interventions

Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AGDRUG

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β + other MSDMDs / Cohort 2IFN-β / Cohort 1
Extavia (interferon beta-1b), Novartis Pharma AGDRUG

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β + other MSDMDs / Cohort 2IFN-β / Cohort 1
Rebif (interferon beta-1a), Merck Serono Europe LtdDRUG

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β + other MSDMDs / Cohort 2IFN-β / Cohort 1
Plegridy (peginterferon beta-1a), Biogen Idec LtdDRUG

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β / Cohort 1
Avonex (interferon beta-1a), Biogen Idec LtdDRUG

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β + other MSDMDs / Cohort 2IFN-β / Cohort 1
MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)DRUG

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

IFN-β + other MSDMDs / Cohort 2No IFN-β + other MSDMDs / Cohort 4Other MSDMDs / Cohort 5
No MSDMDs therapy (control)OTHER

Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)

No MSDMDs / Cohort 3

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many locations

Multiple Locations, Finland

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1bInterferon beta-1apeginterferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 25, 2016

Study Start

May 2, 2016

Primary Completion

August 14, 2018

Study Completion

August 14, 2018

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

FI(1)