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

This study has been completed.

First Received on November 19, 2004. Last Updated on August 2, 2010 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097240

Purpose

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

Condition	Phase
Psoriasis Pregnancy	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) During Pregnancy

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment:	18
Study Start Date:	January 2005
Study Completion Date:	September 2009

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pregnant women solicited through advertising, physician and patient awareness, and other programs.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097240

Locations

United States, North Carolina
FOLLOW Raptiva Pregnancy Registry
Morrisville, North Carolina, United States, 27560

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Ivor Caro, M.D

Genentech

More Information

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00097240 History of Changes
Other Study ID Numbers:	ACD3100g
Study First Received:	November 19, 2004
Last Updated:	August 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

FOLLOW
Psoriasis
Pregnancy

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2012