MedTrace Logo

Biogen Multiple Sclerosis Pregnancy Exposure Registry

NCT01911767 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 408

Last updated 2022-06-21

No results posted yet for this study

Summary

The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).

Conditions

Interventions

DRUG

Dimethyl fumarate

Administered as specified in treatment arm.

DRUG

Peginterferon beta-1a

Administered as specified in treatment arm.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-30
Primary Completion
2022-02-10
Completion
2022-02-10

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01911767 on ClinicalTrials.gov