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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
trial testing Interferon Beta Therapy in Multiple Sclerosis in 470 participants. Completed in 15 October 2021.
15 October 2021
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 470 |
| Start date | 30 April 2021 |
| Primary completion | 15 October 2021 |
| Estimated completion | 15 October 2021 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Interferon Beta Therapy — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
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):
-
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 -
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:
- PubMed search for NCT04655222
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04655222 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biogen
- Last refreshed: 18 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04655222.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing