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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

Completed Last updated 18 April 2023
What this trial tests

trial testing Interferon Beta Therapy in Multiple Sclerosis in 470 participants. Completed in 15 October 2021.

Timeline
30 April 2021
Primary endpoint
15 October 2021
15 October 2021

Quick facts

Lead sponsorBiogen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment470
Start date30 April 2021
Primary completion15 October 2021
Estimated completion15 October 2021
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Biogen — full company profile →

Who can join

18 and older, female only, with Multiple Sclerosis or Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Impact of interferon beta exposure on birth outcome and child development - Results from the post-authorisation safety study PRIMA.
    Klehmet J, Begus-Nahrmann Y, Taipale K, Niemczyk G, et al · · 2023 · cited 5× · PMID 37393802 · DOI 10.1016/j.msard.2023.104844
  2. 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.
    Klehmet J, Begus-Nahrmann Y, Taipale K, Niemczyk G, et al · · 2023 · PMID 38107443 · DOI 10.1177/17562864231214041

Verify or expand the search:

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

Other Biogen trials

Trials by the same sponsor.

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Data sources for this page

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