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Psoriasis Inflammation and Systemic Co Morbidities

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University
ClinicalTrials.gov Identifier:
NCT01170715
First received: July 26, 2010
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psoriasis Inflammation and Systemic Co-Morbidities: Is it Preventable or Reversible?

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • To analyze fat using histology and gene expression before during and after treatment. [ Time Frame: Every 3 months for a year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To analyze immunological biomarkers of inflammation in the blood using electrochemiluminescence of the MSD systems approach [ Time Frame: Every 3 months for a year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Moderate to severe psoriasis

Criteria

Inclusion Criteria:

  1. Age > 18years
  2. Psoriasis affecting Body Surface Area (BSA) > 10% after washout
  3. No systemic anti psoriatic therapy < 30days
  4. Features of the metabolic syndrome (At least one of the following) :

Insulin resistance e.g. fasting insulin>9 pmol/L Blood glucose 100-125 mg/dl TG 150-350 mg/dl HDL<40 mg/dl (for females) and HDL<50 mg/dl (for males) BP > 120/85 BMI > 25 5. Plaque type Psoriasis-

Exclusion Criteria:

Overt diabetes (> 135 mg/dL fasting blood glucose on two (2) separate occasions 2. Hypertension as defined as a systolic BP > 140 &/or a diastolic pressure > 90.

Cannot be on more then one (1) antihypertensive medication 3. Currently have any known malignancy or have a history of malignancy in the 5 past years excluding basal cell carcinoma 4. S/P Cardiovascular event such as Myocardial infarction, any open heart surgery, stroke or other vascular occlusive event 5. Current smokers 6. Known allergy to etanercept 7. Positive PPD 8. HIV positive 9. HCV or HBV positive 10. HbA1C >7 11. current use of hypoglycemic medication 12. Current use of a statin 13. Current use of any anticoagulants 14. Current use of any anti-inflammatory medications (except inhaled steroids) 15. 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. 16.Females of childbearing age who are pregnant or breast-feeding or not using a contraceptive. 17. NYHA Class III and Class IV heart failure

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Batya Davidovici, MD The Rockefeller University
  More Information

Additional Information:
No publications provided

Responsible Party: Mary Sullivan-Whalen, Clinical Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT01170715     History of Changes
Other Study ID Numbers: BDA0688
Study First Received: July 26, 2010
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Psoriasis
Co morbidities
Inflammation

Additional relevant MeSH terms:
Inflammation
Psoriasis
Pathologic Processes
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014