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Psoriasis Inflammation and Systemic Co Morbidities

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ClinicalTrials.gov Identifier: NCT01170715
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University

Brief Summary:

Psoriasis is a chronic relapsing prevalent inflammatory disease affecting 2-4% of the world's population. Severe psoriasis is a disabling disease affecting the physical and emotional well being of patients, and its effect on quality of life is similar to that seen with other major medical diseases such as diabetes, rheumatoid arthritis, and cancer. Lately, it is increasingly being recognized that psoriasis is not merely a skin disease but is probably associated with other co-morbidities such as psoriatic arthritis, Crohn's disease, the metabolic syndrome and cardio-vascular diseases (CVD). The metabolic syndrome is a combination of diabetes mellitus type II (or insulin resistance), hypertension, central obesity, and combined hyperlipidemia (elevated LDL; decreased HDL; elevated triglycerides). As the literature linking psoriasis and the metabolic syndrome expands, also reports of an increased rate of CVD mortality in psoriasis patients accumulates. These data emphasize that metabolic dysregulations are the leading risk factors for occlusive vascular events and early death in patients with severe psoriasis. Progress in understanding the pathogenesis of these apparently diverse diseases has discovered that low-grade systemic inflammation might be the common physiological pathway that may provide the biological plausibility of the associations discovered in the epidemiological studies. Since some of these co-morbidities often become clinically apparent years after the onset of psoriasis we assume that controlling systemic inflammation might prevent or reverse some of these co-morbidities.

Presently there is no study in psoriasis that shows that a "systemic" co-morbidity can be prevented or treated by reversing skin inflammation.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Etanercept Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be screened and enrolled based on inclusion/exclusion criteria. Those enrolled will have intervention for 52 weeks and assessed for outcome measures along the way.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Psoriasis Inflammation and Systemic Co-Morbidities: Is it Preventable or Reversible?
Actual Study Start Date : July 13, 2010
Actual Primary Completion Date : September 9, 2013
Actual Study Completion Date : September 9, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental Group
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Drug: Etanercept
self-administered for 52 weeks
Other Name: Enbrel



Primary Outcome Measures :
  1. Change in histology [ Time Frame: From baseline, every 3 months, up to one year (52 weeks). ]
    To analyze specimens using histology and gene expression before, during, and after treatment.

  2. Change in gene expression [ Time Frame: From baseline, every 3 months, up to one year (52 weeks). ]
    To analyze specimens using histology and gene expression before, during, and after treatment.


Secondary Outcome Measures :
  1. To analyze immunological biomarkers of inflammation in the blood using electrochemiluminescence of the MSD systems approach [ Time Frame: From baseline, every 3 months, up to one year (52 weeks). ]
    hs-CRP, IL-2 Receptor, Plasminogen activator inhibitor complex (PAI), tissue plasminogen activator (TPA), anti pro BNP, E-selectin, inflammatory cytokines and markers, metabolic markers, vascular markers [IL= interleukin; MMP =Matrix metallopeptidase; ICAM=Inter-Cellular Adhesion Molecule; VCAM= vascular cell adhesion molecule; SAA=Serum amyloid A;GLP-1= Glucagon-like peptide-1;CRP C-Reactive protein. The markers list: IFN-γ, IL-2, IL-4, IL-5, IL-10, IL-12p70, IL-13, IFN-γ, IL-2, IL-4, IL-5, IL-10, IL-12p70, IL-13, MMP- 1, MMP-3 and MMP-9, CRP, sICAM-1, sVCAM-1, SAA, adiponectin, GLP-1,insulin, resistin and other future markers not known at this time.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18years
  • Psoriasis affecting Body Surface Area (BSA) ≥ 10% after washout
  • No systemic anti psoriatic therapy ≤ 30days
  • Plaque type Psoriasis

Exclusion Criteria:

  • Overt diabetes (> 135 mg/dL fasting blood glucose on two (2) separate occasions
  • Hypertension as defined as a systolic BP > 140 &/or a diastolic pressure > 90. -Cannot be on more then one (1) antihypertensive medication.
  • Currently have any known malignancy or have a history of malignancy in the 5 past years excluding basal cell carcinoma.
  • S/P Cardiovascular event such as Myocardial infarction, any open heart surgery, stroke or other vascular occlusive event.
  • Known allergy to etanercept
  • HIV positive
  • HBV positive
  • HbA1C >7
  • Current use of hypoglycemic medication
  • Current use of any anticoagulants
  • Current use of any anti-inflammatory medications (except inhaled steroids)
  • Females of childbearing age who are pregnant or breast-feeding or not using a contraceptive.
  • NYHA Class III and Class IV heart failure
  • Positive PPD
  • History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the Principal Investigator, make the candidate ineligible for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170715


Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Weill Medical College of Cornell University
Investigators
Principal Investigator: James Krueger, MD, PhD The Rockefeller University

Responsible Party: Mary Sullivan-Whalen, Clinical sub-Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT01170715     History of Changes
Other Study ID Numbers: BDA0688
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary Sullivan-Whalen, Rockefeller University:
Psoriasis
Co morbidities
Inflammation

Additional relevant MeSH terms:
Inflammation
Psoriasis
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors