NCT00338741

Rebif® Pregnancy Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: EMD Serono · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed pregnancies. This rate will be compared with the rate of spontaneous abortions in patients with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy Exposure Registries

Detailed description

This study is a post-approval commitment to follow Rebif®-exposed pregnancies and compare them to non-Rebif® exposed pregnancies to evaluate rate of spontaneous abortion, fetal abnormality or pregnancy related health outcomes.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2002-12-01
• Primary completion: 2007-10-01
• Completion: 2008-02-01
• First posted: 2006-06-20
• Last updated: 2013-08-05
• Results posted: 2010-06-02

Locations

1 site across 1 country: United States