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

NCT04655222 | Completed

• 1 other identifier: DE-PEG-11650
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With Live Births Without Congenital Anomalies

  up to end of study (4 months)

• Percentage of Participants With Live Births With Congenital Anomalies

  up to end of study (4 months)

• Percentage of Participants With Ectopic Pregnancies

  8 weeks of gestation

• 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

• Percentage of Participants With Elective Abortions

  up to Week 20 of gestation

• Percentage of Participants With Preterm Births

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

  up to 37 weeks of gestation

• 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 Outcomes (18)

• Average Weight of the Children

  From Birth up to Month 48

• Average Length of the Children

  From Birth up to Month 48

• Average Head Circumference of the Children

  From Birth up to Month 48

• Percentage of Abnormalities Diagnosed During Pediatric Check-ups

  up to Month 48

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

  up to 39 weeks of gestation

Study Arms (1)

All Participants

Pregnant Multiple Sclerosis (MS) participants treated with SC interferon beta therapy or an IM interferon beta therapy in the German PSP of the MSSC.

Drug: Interferon Beta Therapy

Interventions

Interferon Beta Therapy DRUG

Administered as specified in the treatment arm.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Göttingen, Germany

Location

Related Publications (2)

• Klehmet J, Begus-Nahrmann Y, Taipale K, Niemczyk G, Rehberg-Weber K. Pregnancy outcomes in female multiple sclerosis patients exposed to intramuscular interferon beta-1a or peginterferon beta-1a reported in a German Patient Support Programme - results from the non-interventional post-authorization safety study PRIMA. Ther Adv Neurol Disord. 2023 Dec 15;16:17562864231214041. doi: 10.1177/17562864231214041. eCollection 2023.

  PMID: 38107443 DERIVED

• Klehmet J, Begus-Nahrmann Y, Taipale K, Niemczyk G, Rehberg-Weber K. Impact of interferon beta exposure on birth outcome and child development - Results from the post-authorisation safety study PRIMA. Mult Scler Relat Disord. 2023 Sep;77:104844. doi: 10.1016/j.msard.2023.104844. Epub 2023 Jun 24.

  PMID: 37393802 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: April 30, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)