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NCT00097240 Clinical Trial

An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW)

Pregnancy Clinical Trial

— FOLLOW  

Official title:
The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00097240
Other study ID # ACD3100g
Secondary ID
Status Completed
Phase Phase 4
First received November 19, 2004
Last updated August 2, 2010
Start date January 2005
Est. completion date September 2009

Study information
Verified date August 2010
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Any patient who has used Raptiva within 6 weeks prior to conception or during her pregnancy may be included in the Registry. Enrollment is based on Raptiva exposure, whether inadvertent or deliberate, in relation to pregnancy. Enrollment should occur as early as possible during the pregnancy and must occur prior to knowledge of pregnancy outcome.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States FOLLOW Raptiva Pregnancy Registry Morrisville North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

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