Skip to main content
OpenTrials
Completed

NCT Number: NCT01320293

Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Dermatology Clinical Trials Unit

Chapel Hill, North Carolina, 27516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

Drug

40mg subcutaneously, every other week for 6 months

Other names: Humira

Primary outcomes

  1. Percentage Change in Endothelial Function Compared to Baseline.

    Time frame: 6 months

    Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).

Secondary outcomes

  1. Changes in IL-6 Profile Compared to Baseline

    Time frame: 6 months

    IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.

  2. Changes in Adiponectin Profile Compared to Baseline

    Time frame: 24 weeks

    Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • AbbVie

Registry information

Official study title

Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2011
Registry last updated
Dec 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.