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NCT01866592 · ClinicalTrials.gov registry record · Phase 4
Vascular Inflammation in Psoriasis - Extension Study
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT01866592: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT01866592 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01866592, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.
Primary Outcome
Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and baseline scans (prior to randomization in the VIP Trial). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR). If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were ra
Interventions
- DRUG Adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-10-27 |
| Phase | Phase 4 |
What the finished NCT01866592 record still lists
NCT01866592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Adalimumab is the first listed.
NCT01866592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01866592 about?
NCT01866592 is a clinical study titled "Vascular Inflammation in Psoriasis - Extension Study". VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedure...
What is the current status of trial NCT01866592?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2013-04. Estimated completion is 2016-10-27.
What interventions are being tested in trial NCT01866592?
The interventions under investigation include: Adalimumab (DRUG).
Who is sponsoring clinical trial NCT01866592?
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 NCT01866592's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 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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