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NCT01553058 · ClinicalTrials.gov registry record · Phase 4
Vascular Inflammation in Psoriasis Trial (The VIP Trial)
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
NCT01553058: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT01553058 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 97 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553058, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis. This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation. This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis.
Interventions
- DRUG Placebo Injection
- DRUG Adalimumab (Humira)
- OTHER NB-UVB phototherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-10-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01553058
The ClinicalTrials.gov registry entry for NCT01553058 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Injection is the first listed.
NCT01553058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01553058 about?
NCT01553058 is a clinical study titled "Vascular Inflammation in Psoriasis Trial (The VIP Trial)". The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on system...
What is the current status of trial NCT01553058?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2012-07. Estimated completion is 2016-10-27.
What interventions are being tested in trial NCT01553058?
The interventions under investigation include: Placebo Injection (DRUG), Adalimumab (Humira) (DRUG), NB-UVB phototherapy (OTHER).
Who is sponsoring clinical trial NCT01553058?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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