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Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

This study has been completed.
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: October 27, 2016
Last verified: October 2016

March 18, 2011
October 27, 2016
March 2011
March 2015   (Final data collection date for primary outcome measure)
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%).
Percentage Change in Endothelial Function Compared to Baseline. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01320293 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Changes in cytokine profile compared to baseline [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis

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).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
40mg subcutaneously, every other week for 6 months
Other Name: Humira
Experimental: Adalimumab 40mg
Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months
Intervention: Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2015
March 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01320293
ABBO-0001
No
Not Provided
No
no plan to share data
Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
AbbVie
Principal Investigator: Aida Lugo-Somolinos, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP