Psoriasis Inflammation and Systemic Co Morbidities

NCT01170715 | Completed Results

• 1 other identifier: BDA0688
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Co morbidities; Inflammation

Outcome Measures

Primary Outcomes (2)

• Change in Histology

  To analyze specimens using histology and gene expression before, during, and after treatment.

  From baseline, every 3 months, up to one year (52 weeks).

• Percentage Change in IL17A Gene Expression

  To analyze specimens using histology and gene expression before, during, and after treatment. Percentage Change in IL17A gene expression is the mean of change from baseline divided by mean of baseline and then multiplied by 100: 100\*(PostTreatment-Baseline)/Baseline. Both PostTreatment and Baseline values are means but the percentage is a number.

  From baseline, every 3 months, up to one year (52 weeks). Except at 9 months. Biopsies were taken at baseline, 3 months, 6 months and 12 months.

Secondary Outcomes (1)

• Percentage of Change in IL17A.

  From baseline, every 3 months, up to one year (52 weeks). Biopsies were taken at baseline, 3 months, 6 months, 9 months and 12 months.

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

Etanercept DRUG

self-administered for 52 weeks

Also known as: Enbrel

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockefeller University: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Psoriasis; Inflammation

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: James G. Krueger MD, PhD
• Organization: Rockefeller University

kruegej@rockefeller.edu

212-327-7730

Study Officials

• James Krueger, MD, PhD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: July 13, 2010
• Primary Completion: September 9, 2013
• Study Completion: September 9, 2013
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-02

Locations

US (1)