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

NCT ID: NCT00097240

Last Updated: 2010-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Genentech, Inc.

Principal Investigators

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Ivor Caro, M.D

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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FOLLOW Raptiva Pregnancy Registry

Morrisville, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ACD3100g

Identifier Type: -

Identifier Source: org_study_id

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