Clinical trial NCT04655222: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 470
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All female participants treated with SC Peginterferon beta-1a therapy or IM Interferon beta-1a therapy who fulfil the inclusion criteria are eligible to participate in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Live Births Without Congenital Anomalies
timeFrame: up to end of study (4 months)
measure: Percentage of Participants With Live Births With Congenital Anomalies
timeFrame: up to end of study (4 months)
measure: Percentage of Participants With Ectopic Pregnancies
timeFrame: 8 weeks of gestation
measure: Percentage of Participants With Spontaneous Abortions
timeFrame: up to 22 weeks of gestation
measure: Percentage of Participants With Elective Abortions
timeFrame: up to Week 20 of gestation
measure: Percentage of Participants With Preterm Births
timeFrame: up to 37 weeks of gestation
measure: Percentage of Participants With Stillbirths
timeFrame: from 22 week up to 39 weeks of gestation
Secondary outcomes:
measure: Average Weight of the Children
timeFrame: From Birth up to Month 48
measure: Average Length of the Children
timeFrame: From Birth up to Month 48
measure: Average Head Circumference of the Children
timeFrame: From Birth up to Month 48
measure: Percentage of Abnormalities Diagnosed During Pediatric Check-ups
timeFrame: up to Month 48
measure: Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
timeFrame: up to 39 weeks of gestation
measure: Time to Discontinuation of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy
timeFrame: up to 39 weeks of gestation
measure: Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
timeFrame: up to 39 weeks of gestation
measure: Time to Start Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy
timeFrame: up to 39 weeks of gestation
measure: Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth
timeFrame: up to end of study (4 months)
measure: Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth
timeFrame: up to end of study (4 months)
measure: Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy
timeFrame: up to end of study (4 months)
measure: Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth
timeFrame: up to end of study (4 months)
measure: Percentage of Women Using Other Therapies During Pregnancy
timeFrame: up to 39 weeks of gestation
measure: Percentage of Multiple Sclerosis Relapses in Women with Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Before, During and After Pregnancy
timeFrame: up to end of study (4 months)
measure: Change From Baseline Expanded Disability Status Scale (EDSS) During and After Pregnancy to Expanded Disability Status Scale (EDSS) Before Pregnancy
timeFrame: Week 0 up to Week 39 of gestation
measure: Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy
timeFrame: up to end of study (4 months)
measure: Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding
timeFrame: up to end of study (4 months)
measure: 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
timeFrame: up to end of study (4 months)
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: