Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

NCT01320293 | Completed Results

• 1 other identifier: ABBO-0001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Moderate to Severe Chronic plaque type psoriasis

Outcome Measures

Primary Outcomes (1)

• 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%).

  6 months

Secondary Outcomes (2)

• Changes in IL-6 Profile Compared to Baseline

  6 months

• Changes in Adiponectin Profile Compared to Baseline

  24 weeks

Study Arms (1)

Adalimumab 40mg

EXPERIMENTAL

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

Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]

Interventions

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] DRUG

40mg subcutaneously, every other week for 6 months

Also known as: Humira

Adalimumab 40mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• AbbVie: collaborator

Study Sites (1)

UNC Dermatology Clinical Trials Unit

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Smaller number of subjects analyzed due to low enrollment. Technical problems with Elisa measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Aida Lugo-Somolinos MD
• Organization: University of North Carolina

alugosom@med.unc.edu

919-843-9447

Study Officials

• Aida Lugo-Somolinos, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 26, 2016
• Results First Posted: December 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)