CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00338741
NCT00338741N/ACompleted

Rebif® Pregnancy Registry

EMD Serono·observational·Posted Jun 20, 2006·Updated Aug 5, 2013

In Brief

An observational study for Multiple Sclerosis. Completed, enrolled 36 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2006
Enrollment StartDec 1, 2002
Primary CompletionOct 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.0 years ago