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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097240
Recruitment Status : Completed
First Posted : November 22, 2004
Last Update Posted : August 4, 2010
Sponsor:
Information provided by:
Genentech, Inc.

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

Condition or disease
Psoriasis Pregnancy

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Study Type : Observational
Actual Enrollment : 18 participants
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
Study Start Date : January 2005
Actual Study Completion Date : September 2009




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097240


Locations
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United States, North Carolina
FOLLOW Raptiva Pregnancy Registry
Morrisville, North Carolina, United States, 27560
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Ivor Caro, M.D Genentech, Inc.
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Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097240    
Other Study ID Numbers: ACD3100g
First Posted: November 22, 2004    Key Record Dates
Last Update Posted: August 4, 2010
Last Verified: August 2010
Keywords provided by Genentech, Inc.:
FOLLOW
Psoriasis
Pregnancy
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases