Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320293
• Other study ID #: ABBO-0001
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: April 17, 2015
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Adalimumab
40mg subcutaneously, every other week for 6 months

Locations

Country	Name	City	State
United States	UNC Dermatology Clinical Trials Unit	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in endothelial function compared to baseline.		6 months	No
Secondary	Changes in cytokine profile compared to baseline		6 months	No