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Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01320293
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Psoriasis Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis
Study Start Date : March 2011
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Adalimumab 40mg
Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months
Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
40mg subcutaneously, every other week for 6 months
Other Name: Humira

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320293

United States, North Carolina
UNC Dermatology Clinical Trials Unit
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Aida Lugo-Somolinos, MD University of North Carolina, Chapel Hill
More Information

Responsible Party: Aida Lugo-Somolinos, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01320293     History of Changes
Other Study ID Numbers: ABBO-0001
First Posted: March 22, 2011    Key Record Dates
Results First Posted: December 26, 2016
Last Update Posted: December 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share data

Keywords provided by Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill:
Moderate to Severe Chronic plaque type psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents