Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

NCT ID: NCT01320293

Last Updated: 2016-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-03-31

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).

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab 40mg

Adalimumab 40 MG/0.8 ML Subcutaneous Solution \[HUMIRA\] Dose administered every other week for 6 months

Group Type: EXPERIMENTAL

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

Intervention Type: DRUG

40mg subcutaneously, every other week for 6 months

Interventions

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

40mg subcutaneously, every other week for 6 months

Intervention Type: DRUG

Other Intervention Names

Humira

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Aida Lugo-Somolinos, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aida Lugo-Somolinos, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Dermatology Clinical Trials Unit

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

ABBO-0001

Identifier Type: -

Identifier Source: org_study_id