Cytokines and Vascular Inflammation in Psoriasis

NCT02305953 | Completed

• 1 other identifier: Inno-6037
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

Psoriasis is an inflammatory disease involving the skin, the joints and the vascular compartment. The mechanisms linking inflammation in the skin and joints and in the vascular walls are poorly understood. One hypothesis for the increase in vascular inflammation observed in patients with psoriasis involves circulating pro-inflammatory cytokines. Patients with psoriasis have an increase in serum levels of tumor necrosis factor alpha (TNF-alpha), Interleukin-17 (IL-17), IL-22, IL-6 as well as a the chemokine S100A913. It is possible that one of those cytokines/chemokine induces vascular inflammation in the vascular compartment. The purpose of this cross sectional retrospective study is to highlight the correlation between vascular wall inflammation using 18F-2-fluoro-2-deoxy-D-glucose - Positron Emission Tomography (FDG-PET) fluorodeoxyglucose technology and pro-inflammatory cytokines/chemokine.

Conditions

Vascular Inflammation; Psoriasis; Coronary Atherosclerosis

Keywords

Psoriasis; Vascular Inflammation; Coronary Atherosclerosis; Ascending aorta; PET scan; Cytokine; Chemokine

Outcome Measures

Primary Outcomes (1)

• Correlation between serum cytokine levels (pg/mL) and TBR in the ascending aorta.

  Correlation between serum levels of various cytokines including TNF alpha, IL-17, IL-22 and IL-6 and vascular inflammation measured as TBR using FDG-PET in patients with moderate to severe psoriasis

  Baseline

Secondary Outcomes (1)

• Correlation between a serum chemokine (S100A9 (pg/mL)) levels and TBR in the ascending aorta.

  Baseline

Study Arms (1)

Frozen serum

The cohort consists of original subjects from the Inno-6025 Trial who previously consented to measuring protein in the blood involved in skin inflammation.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects previously enrolled in the Inno-6025 Trial (ClinicalTrials.gov Identifier NCT01722214)

You may qualify if:

• Patient has plaque psoriasis.
• Patient has at least a 6 month history of plaque psoriasis.
• Patient has a Body Surface Area (BSA) covered with psoriasis of 5% or more at Day 0.
• Patient is a candidate for systemic therapy.
• Patient is male or female, 18 to 80 years of age at time of consent.
• Patient's weight at screening is a maximum of 180 kg.
• Patient using medication to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation must be on a stable dose for at least 8 weeks before Day 0.
• Patient has an ascending aorta atherosclerotic plaque inflammation target-to-background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.
• Patient or patient's partner has been in a menopausal state for at least a year, is surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation or vasectomy), is clinically diagnosed infertile, has a same-sex partner, is abstinent, or is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Effective contraceptive methods are:
• Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
• Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
• Intrauterine device (IUD);
• Female patients of childbearing potential must have a negative serum pregnancy test at the Screening visit.
• Patient is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, and Chest X-Ray (CXR) performed at Screening.
• Patient will be evaluated for latent TB infection with a purified protein derivative (PPD) or a Quantiferon Gold test and CXR. Patient who demonstrates evidence of latent TB infection (either PPD more than or equal to 5 mm of induration or positive Quantiferon Gold, irrespective of Bacillus Calmette-Guerin (BCG) vaccination status and negative CXR findings for active TB, and/or suspicious CXR findings) will not be allowed to participate in the study.

You may not qualify if:

• Patient has spontaneously improving or rapidly deteriorating plaque psoriasis.
• Patient has other active infections (bacterial, fungal or viral) or skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis or with patient's safety.
• Patient has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex (a component of the pre-filled syringe).
• Patient has used a non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0.
• Patient has used an investigational chemical or biological agent less than 30 days or 5 half-lives prior to the Day 0 visit (whichever is longer).
• Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0.
• Patient has used a systemic immunosuppressor (eg. Azathioprine, 6-mercaptopurine) less than 30 days before Day 0.
• Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
• Patient has used a topical treatment for psoriasis or has used phototherapy within the last 2 weeks prior to Day 0 (at the exception of low potency topical corticosteroids for groin, genitals, face, inframammary area, palms and soles).
• Patient has received Anakinra/Kineret within the last 2 weeks prior to the Day 0 visit or is likely to receive Anakinra/Kineret during the course of the study
• Patient has a poorly controlled medical condition, such as uncontrolled diabetes, documented history of recurrent infections, unstable ischemic heart disease, class III or IV (New York Heart Association Functional Classification; NYHA) congestive heart failure, an ejection fraction of less than 30%, recent stroke (within the past 3 months), chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study.
• Patient has had a myocardial infarction or has been hospitalized for a cardiac condition within the past 12 weeks.
• Patient has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, carotid endarterectomy, stent installation or carotid revascularization within 12 weeks of Day 0.
• Patient has had a percutaneous coronary intervention in the past 12 months.
• Patient plans for a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation during the course of the study.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• AbbVie: collaborator

Study Sites (4)

Lynderm Research

Markham, Ontario, L3P 1X2, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Clinique Dre Isabelle Delorme

Drummondville, Quebec, J2B 5L4, Canada

Location

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Psoriasis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: December 3, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-11

Locations

CA (4)