Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01320293
First received: March 18, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 Intervention
Psoriasis
Drug: Adalimumab

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Percentage change in endothelial function compared to baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cytokine profile compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: adalimumab
active
Drug: Adalimumab
40mg subcutaneously, every other week for 6 months
Other Name: Humira

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320293

Locations
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
AbbVie
Investigators
Principal Investigator: Aida Lugo-Somolinos, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

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
Study First Received: March 18, 2011
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Moderate to Severe Chronic plaque type psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014