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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04655222
Other study ID # DE-PEG-11650
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2021
Est. completion date October 15, 2021

Study information

Verified date April 2023
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available. The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.


Description:

This is an observational study with focus on existing pregnancy reporting forms (retrospective part) and a patient's questionnaire which is completed at a single point of time (prospective part). Main data source for the retrospective data (from 2014 until December 2019) will be captured from multiple sclerosis service-center (MSSC) database, i.e. the entered pregnancy report (to be completed as soon as pregnancy becomes known) and pregnancy outcomes report (to be completed after completion of pregnancy). Prospective data (December 2020 to 31 March 2021) will be captured as standardized ePDF questionnaire completed during telephone interview. If the pregnancy report or the pregnancy outcome report is incomplete, i.e. the data above was not collected, the open questions will be addressed during a telephone interview performed by the MSSC and the new information will be entered into the MSCC database. The patient questionnaire will be completed at a single point of time during the telephone interview performed by the MSSC.


Recruitment information / eligibility

Status Completed
Enrollment 470
Est. completion date October 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) (CIS indication only applicable for interferon beta-1a) - Exposure to either SC Peginterferon beta-1a therapy or an IM Interferon beta-1a therapy before or during pregnancy - Registered in the PSP of the multiple sclerosis service- center (MSSC) and agreed in writing to the privacy policy of the registration form - Reported pregnancy data (pregnancy report and pregnancy outcome report) available at MSSC. Note: only pregnancy data (i.e. obtained until 15 October 2020) will be considered. - Pregnancy outcome in the retrospectively collected data was a live birth Exclusion Criteria: Any criteria that does not fulfil the above-mentioned inclusion criteria. NOTE: Other protocol defined Inclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Interferon Beta Therapy
Administered as specified in the treatment arm.

Locations

Country Name City State
Germany Research Site Göttingen

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Live Births Without Congenital Anomalies up to end of study (4 months)
Primary Percentage of Participants With Live Births With Congenital Anomalies up to end of study (4 months)
Primary Percentage of Participants With Ectopic Pregnancies 8 weeks of gestation
Primary Percentage of Participants With Spontaneous Abortions A spontaneous abortion is defined as fetal death before 22 weeks of gestation. up to 22 weeks of gestation
Primary Percentage of Participants With Elective Abortions up to Week 20 of gestation
Primary Percentage of Participants With Preterm Births A preterm birth is a birth before 37 completed weeks of gestation. up to 37 weeks of gestation
Primary Percentage of Participants With Stillbirths A still birth is defined as fetal death at >22 weeks gestation. from 22 week up to 39 weeks of gestation
Secondary Average Weight of the Children From Birth up to Month 48
Secondary Average Length of the Children From Birth up to Month 48
Secondary Average Head Circumference of the Children From Birth up to Month 48
Secondary Percentage of Abnormalities Diagnosed During Pediatric Check-ups up to Month 48
Secondary Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy up to 39 weeks of gestation
Secondary Time to Discontinuation of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy up to 39 weeks of gestation
Secondary Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy up to 39 weeks of gestation
Secondary Time to Start Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy up to 39 weeks of gestation
Secondary Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth up to end of study (4 months)
Secondary Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth up to end of study (4 months)
Secondary Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy up to end of study (4 months)
Secondary Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth up to end of study (4 months)
Secondary Percentage of Women Using Other Therapies During Pregnancy up to 39 weeks of gestation
Secondary Percentage of Multiple Sclerosis Relapses in Women with Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Before, During and After Pregnancy up to end of study (4 months)
Secondary Change From Baseline Expanded Disability Status Scale (EDSS) During and After Pregnancy to Expanded Disability Status Scale (EDSS) Before Pregnancy EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS). Scores range from 0.0 (normal) to 10.0 (death due to MS). Week 0 up to Week 39 of gestation
Secondary Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy up to end of study (4 months)
Secondary Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding up to end of study (4 months)
Secondary Time to First Multiple Sclerosis (MS) Relapse After Introduction of the First Supplemental Feedings in Women With Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Lactation up to end of study (4 months)
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