PsoriasisFOLLOWNCT00097240
An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW)
An observational study of Psoriasis and Pregnancy, run by Genentech, Inc. at 1 site in United States.
Trial summary
The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva. Read more about this study
- Who is it for?
- Any age, women only
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women solicited through advertising, physician and patient awareness, and other programs.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
FOLLOW Raptiva Pregnancy Registry
Morrisville, North Carolina, 27560
About this study
Official title: The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) During Pregnancy
The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva.
- Keywords
- FOLLOW, Psoriasis, Pregnancy
- Medical subject headings
- Psoriasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2004 (estimated)
- Study startJan 2005
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ivor Caro, M.D, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097240
- Sponsor's protocol ID
- ACD3100g
- Acronym
- FOLLOW
- Status last verified
- Aug 2010
- First submitted
- 19 Nov 2004
- Last updated
- 4 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) During Pregnancy
- ClinicalTrials.gov ID
- NCT00097240
- Acronym / sponsor ID
- FOLLOW / ACD3100g
- Keywords
- FOLLOW, Psoriasis, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Raptiva Pregnancy Registry was a prospective observational study established to obtain data on pregnancy outcomes of women who were exposed to Raptiva.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women solicited through advertising, physician and patient awareness, and other programs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivor Caro, M.D study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Pregnancy, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2010.