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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Interferon beta
What it measured
Main measures
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
up to 22 weeks of gestation
Percentage of Participants With Elective Abortions
up to Week 20 of gestation
Percentage of Participants With Preterm Births
up to 37 weeks of gestation
Percentage of Participants With Stillbirths
from 22 week up to 39 weeks of gestation
Other measures (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
Immune responseTime 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
Immune responsePercentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
up to 39 weeks of gestation
Immune responseTime to Start Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy
up to 39 weeks of gestation
Immune responsePercentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth
up to end of study (4 months)
Immune responseTime to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth
up to end of study (4 months)
Immune response
Who could take part
Relapsing MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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: 10.1177/1756286423Results
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.
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History
Started
Apr 2021
Main results due
Oct 2021
Finished
Oct 2021
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