Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support Program

Multiple Sclerosis Clinical Trial

Official title:

Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655222
• Other study ID #: DE-PEG-11650
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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)