Clinical trial NCT01320293: Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
Official title: Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Moderate to Severe Chronic plaque type psoriasis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2011-03-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.

In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).


Eligibility criteria: Inclusion Criteria:

* Must understand and voluntarily sign an informed consent form.
* Must be male or female and age 18-55 years at time of consent.
* Must be able to adhere to the study visit schedule and other protocol requirements
* Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
* Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
* Negative PPD at Screening or 3 months earlier.
* Have not used any biologic treatment for psoriasis in the past 12 months.

Exclusion Criteria:

* Inability to provide voluntary consent
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Pregnant, trying to become pregnant or breastfeeding
* Prior diagnosis of coronary artery disease (CAD) or heart disease.
* Systemic fungal infection
* History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative \[PPD\] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
* History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
* Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
* Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
* History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
* Positive Hepatitis B Surface antigen at screening
* Malignancy or history of malignancy (except for treated \[ie, cured\] basal-cell skin carcinomas \> 3 years prior to screening)
* History of any demyelinating disorder such as multiple sclerosis.

Primary outcomes:
measure: Percentage Change in Endothelial Function Compared to Baseline.
timeFrame: 6 months
Secondary outcomes:
measure: Changes in IL-6 Profile Compared to Baseline
timeFrame: 6 months
measure: Changes in Adiponectin Profile Compared to Baseline
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Dermatology Clinical Trials Unit
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Aida Lugo-Somolinos, MD
role: PRINCIPAL_INVESTIGATOR
References: