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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). 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.
Primary Outcome
Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
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 |
What the finished NCT01553058 record still lists
NCT01553058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Injection is the first listed.
NCT01553058 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01553058's enrollment target sits among peer trials
97 861st of 2000 higher than 1,138 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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