Vascular Inflammation in Psoriasis - Extension Study

Part of paid clinical trials in Sacramento, California.

Sponsor
University of Pennsylvania
Study ID
NCT01866592
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
Apr 2018
Primary completion
Aug 8, 2016
Completion
Oct 27, 2016

Study Design

Enrollment
81 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 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.

Primary Outcome Measure

Change in Vascular Inflammation [ Time Frame: 52 weeks (continuation group) or 64 weeks (crossover group) ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, Davis Health SystemSacramentoCalifornia95816-
University of ColoradoDenverColorado80045-
National Heart, Lung, and Blood InstituteBethesdaMaryland20892-
Buffalo Medical GroupBuffaloNew York14221-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Menter Dermatology Research InstituteDallasTexas75246-
Center for Clinical StudiesHoustonTexas77004-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Sacramento, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of California, Davis Health System· Sacramento, CAUniversity of Colorado· Denver, CONational Heart, Lung, and Blood Institute· Bethesda, MDBuffalo Medical Group· Buffalo, NYOregon Health & Science University· Portland, ORUniversity of Pennsylvania· Philadelphia, PA

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