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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097240
First Posted: November 22, 2004
Last Update Posted: August 4, 2010
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.
Information provided by:
Genentech, Inc.
  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:


Further study details as provided by Genentech, Inc.:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
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
United States, North Carolina
FOLLOW Raptiva Pregnancy Registry
Morrisville, North Carolina, United States, 27560
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Ivor Caro, M.D Genentech, Inc.
  More Information

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097240     History of Changes
Other Study ID Numbers: ACD3100g
First Submitted: November 19, 2004
First Posted: November 22, 2004
Last Update Posted: August 4, 2010
Last Verified: August 2010

Keywords provided by Genentech, Inc.:
FOLLOW
Psoriasis
Pregnancy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases