Last reviewed · How we verify
NCT00168714
Avonex Pregnancy Exposure Registry
trial testing BG9418 (interferon beta-1a) in Prenatal Exposure Delayed Effects in 329 participants. Completed in 1 September 2011.
1 September 2011
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 329 |
| Start date | 1 February 2004 |
| Primary completion | 1 September 2011 |
| Estimated completion | 1 September 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- BG9418 (interferon beta-1a) — full drug profile →
Conditions studied
- Prenatal Exposure Delayed Effects — all drugs for Prenatal Exposure Delayed Effects →
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Pregnancy — all drugs for Pregnancy →
Sponsor
Biogen — full company profile →
Who can join
Eligibility, female only, with Prenatal Exposure Delayed Effects or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Record and analyze birth defects and spontaneous fetal losses
Time frame: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy -
Record and analyze pregnancy outcomes
Time frame: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Sponsor's own description
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX<sup>®</sup> Pregnancy Exposure Registry.
Weinstock-Guttman B, Ross AP, Planton J, White K, et al · · 2023 · cited 1× · PMID 37737962 · DOI 10.1007/s40801-023-00384-0
Verify or expand the search:
- PubMed search for NCT00168714
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prenatal Exposure Delayed Effects
Currently open trials in the same condition.
- NCT05813184 — Prenatal Antibiotics and Breast Milk / Neonatal IgA · recruiting
Other Biogen trials
Trials by the same sponsor.
- NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
- NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
- NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
- NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
- NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting
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 NCT00168714 (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: 6 June 2014
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/NCT00168714.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing