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NCT Number: 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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

Göttingen, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon Beta Therapy

Drug

Administered as specified in the treatment arm.

Primary outcomes

  1. Percentage of Participants With Live Births Without Congenital Anomalies

    Time frame: up to end of study (4 months)

  2. Percentage of Participants With Live Births With Congenital Anomalies

    Time frame: up to end of study (4 months)

  3. Percentage of Participants With Ectopic Pregnancies

    Time frame: 8 weeks of gestation

  4. Percentage of Participants With Spontaneous Abortions

    Time frame: up to 22 weeks of gestation

    A spontaneous abortion is defined as fetal death before 22 weeks of gestation.

  5. Percentage of Participants With Elective Abortions

    Time frame: up to Week 20 of gestation

  6. Percentage of Participants With Preterm Births

    Time frame: up to 37 weeks of gestation

    A preterm birth is a birth before 37 completed weeks of gestation.

  7. Percentage of Participants With Stillbirths

    Time frame: from 22 week up to 39 weeks of gestation

    A still birth is defined as fetal death at >22 weeks gestation.

Secondary outcomes

  1. Average Weight of the Children

    Time frame: From Birth up to Month 48

  2. Average Length of the Children

    Time frame: From Birth up to Month 48

  3. Average Head Circumference of the Children

    Time frame: From Birth up to Month 48

  4. Percentage of Abnormalities Diagnosed During Pediatric Check-ups

    Time frame: up to Month 48

  5. Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy

    Time frame: up to 39 weeks of gestation

  6. Time to Discontinuation of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy

    Time frame: up to 39 weeks of gestation

  7. Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy

    Time frame: up to 39 weeks of gestation

  8. Time to Start Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy

    Time frame: up to 39 weeks of gestation

  9. Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth

    Time frame: up to end of study (4 months)

  10. Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth

    Time frame: up to end of study (4 months)

  11. Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy

    Time frame: up to end of study (4 months)

  12. Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth

    Time frame: up to end of study (4 months)

  13. Percentage of Women Using Other Therapies During Pregnancy

    Time frame: up to 39 weeks of gestation

  14. Percentage of Multiple Sclerosis Relapses in Women with Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Before, During and After Pregnancy

    Time frame: up to end of study (4 months)

  15. Change From Baseline Expanded Disability Status Scale (EDSS) During and After Pregnancy to Expanded Disability Status Scale (EDSS) Before Pregnancy

    Time frame: Week 0 up to Week 39 of gestation

    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).

  16. Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy

    Time frame: up to end of study (4 months)

  17. Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding

    Time frame: up to end of study (4 months)

  18. 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

    Time frame: up to end of study (4 months)

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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