CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Adalimumabdrug
Likely dose
Adalimumab 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01866592
NCT01866592Phase 4Completed
CompareCT.gov

Vascular Inflammation in Psoriasis - Extension Study

University of Pennsylvania·interventional·Posted May 31, 2013·Updated May 22, 2018

In Brief

A Phase 4 clinical trial evaluating Adalimumab for Psoriasis and Cardiovascular Disease. Completed, enrolled 81 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis, Cardiovascular Disease
CountriesUnited States
CollaboratorsAbbVie

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2013
Enrollment StartApr 1, 2013
Primary CompletionAug 8, 2016
Study CompletionOct 27, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.1 years ago

Interventions

Adalimumabdrug

Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.