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Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Primary Purpose

Psoriasis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Moderate to Severe Chronic plaque type psoriasis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UNC Dermatology Clinical Trials Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab 40mg

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage Change in Endothelial Function Compared to Baseline.

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%).

Secondary Outcome Measures

Changes in IL-6 Profile Compared to Baseline

IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.

Changes in Adiponectin Profile Compared to Baseline

Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.

Full Information

NCT ID

NCT01320293

First Posted

March 18, 2011

Last Updated

October 27, 2016

Sponsor

University of North Carolina, Chapel Hill

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01320293

Brief Title

Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Moderate to Severe Chronic plaque type psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab 40mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

Other Intervention Name(s)

Humira

Intervention Description

40mg subcutaneously, every other week for 6 months

Primary Outcome Measure Information:

Title

Percentage Change in Endothelial Function Compared to Baseline.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes in IL-6 Profile Compared to Baseline

Description

IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.

Time Frame

6 months

Title

Changes in Adiponectin Profile Compared to Baseline

Description

Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aida Lugo-Somolinos, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Dermatology Clinical Trials Unit

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

no plan to share data

Learn more about this trial

Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

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