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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00097240
First received: November 19, 2004
Last updated: August 2, 2010
Last verified: August 2010
  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

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
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, see Learn About Clinical Studies.

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, Inc.
Investigators
Study Director: Ivor Caro, M.D Genentech, Inc.
  More Information

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, Inc.:
FOLLOW
Psoriasis
Pregnancy

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

ClinicalTrials.gov processed this record on October 20, 2014