Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/3/2014 |
| Start Date: | March 2011 |
| End Date: | September 2015 |
| Contact: | Erika Hanami, BS |
| Email: | hanami@med.unc.edu |
| Phone: | 919-843-5126 |
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).
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).
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.
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