Clinical trial NCT02749396: EPID Multiple Sclerosis Pregnancy Study
Official title: Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: EPID Research
name: Biogen
name: Merck Serono Europe Ltd
name: Novartis Pharmaceuticals
First posted: 2016-04-25
Enrollment: 2089
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

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:

i) FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR: 1 January 2004 - 31 December 2014.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Elective TOPFA for other reasons than IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Elective termination for other reasonsthan IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Stillbirth due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Live birth while different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: MCA due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: 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
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of live birth due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of MCA due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary outcomes:
measure: Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Prevalence of elective TOPFA stratified by specific patient characteristics
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Prevalence of stillbirth stratified by specific patient characteristics
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Prevalence of live birth stratified by specific patient characteristics
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Prevalence of MCA stratified by specific patient characteristics
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
measure: Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure
timeFrame: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Other outcomes:
Locations:
city: Multiple Locations
country: Finland
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: