Vascular Inflammation in Psoriasis - Extension Study (VIP-E)
|ClinicalTrials.gov Identifier: NCT01866592|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Cardiovascular Disease||Drug: Adalimumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vascular Inflammation in Psoriasis - Extension Study|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 3, 2016|
|Actual Study Completion Date :||August 3, 2016|
Single-Arm, open-label extension trial
Single-arm, open label extension trial to continue treatment with Humira (Adalimumab) subcutaneous injection 80mg initial dose followed by 40mg maintenance dose every other week for up to 52 weeks.
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.
Other Name: Humira
- Vascular Inflammation [ Time Frame: Baseline and Week 52 ]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 from the VIP trial and between week 52 of the adalimumab treatment period and week 12 scans from the VIP trial.
- Cardiometabolic Biomarkers [ Time Frame: Baseline - Week 52 ]Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial and between week 52 of the adalimumab treatment period and week 12 assessments from the VIP trial.
- Psoriasis Activity (PASI and PGA) [ Time Frame: Baseline - Week 52 ]Change in psoriasis activity will be assessed using the following standardized measurement tools for psoriasis: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA).
- Safety/Adverse Events [ Time Frame: All visits through 52 week study ]Safety will be assessed by evaluating all subject reported adverse events through the duration of the study.
- Patient-Reported Quality of Life Outcomes [ Time Frame: Baseline - Week 52 ]Patient reported quality of life outcomes will be assessed using the following standard instruments: EuroQol EQ-5D, Dermatology Life Quality Index (DLQI), MEDFICTS dietary assessment instrument, International Physical Activity Questionnaire (IPAQ), and Multidimensional Health Assessment Questionnaire (MDHAQ).
- Cardiometabolic Biomarkers [ Time Frame: Intermediate time points between baseline and week 52 ]Change in metabolic, lipid, and inflammatory biomarker levels at intermediate time points.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866592
|United States, California|
|University of California, Davis Health System|
|Sacramento, California, United States, 95816|
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80045|
|United States, Maryland|
|National Heart, Lung, and Blood Institute|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|Buffalo Medical Group|
|Buffalo, New York, United States, 14221|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Menter Dermatology Research Institute|
|Dallas, Texas, United States, 75246|
|Center for Clinical Studies|
|Houston, Texas, United States, 77004|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Joel M Gelfand, MD MSCE||University of Pennsylvania|