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Vascular InflammationNCT02305953

Cytokines and Vascular Inflammation in Psoriasis

An observational study of Vascular Inflammation and Psoriasis, run by Innovaderm Research Inc. at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
96 participants
Where
4 sitesCanada
Study dates
Oct 2014to Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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.
  • Patient must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
  • Patient must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.

Who cannot join

  • 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.
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  • 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.
  • Patient has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).
  • Patient has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
  • Patient has a history of listeriosis, treated or untreated Tuberculosis (TB), persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days prior to the Day 0 visit or oral anti-infectives within 14 days prior to the Day 0 visit.
  • Patient has received a live attenuated vaccine 28 days or less before Day 0 or plan to receive a live attenuated vaccine during the study and up to 4 months after the last study drug administration..
  • Patient with hepatitis B or hepatitis C viral infection
  • Patient with any of the following: hemoglobin ≤ 10 g/L, white blood cell count ≤ 3.0 X 109/L, platelet count ≤130 X 10^9/L, alanine transaminase (ALT) ≥ 2 times the upper limit of normal, aspartate transaminase (AST) ≥ 3 times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or creatinine ≥ 150 µmol/L.
  • Patient currently uses or plans to use anti-retroviral therapy at any time during the study.
  • Patient is known to have immune deficiency or is immunocompromised.
  • Female patient who is pregnant or breast-feeding or considering becoming pregnant during the study or for 6 months after the last dose of study medication.
  • Patient has a history of clinically significant drug or alcohol abuse in the last year.
  • Patient who plans to travel in an area where tuberculosis is endemic during the study and up to 4 months after the last study drug administration.
  • Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Clinique Dre Isabelle Delorme

    Drummondville, Quebec, J2B 5L4

  • Lynderm Research

    Markham, Ontario, L3P 1X2

  • Innovaderm Research

    Montreal, Quebec, H2K 4L5

  • Windsor Clinical Research Inc.

    Windsor, Ontario, N8W 5L7

Other trials in Canada

About this study

Official title: Correlation Between Serum Levels of Cytokines and a Chemokine and Vascular Inflammation in Patients With Moderate to Severe Psoriasis

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.

Read the detailed description

Baseline frozen serum samples will be identified from the 107 enrolled Inno-6025 (Abbvie A13-935) (ClinicalTrials.gov Identifier NCT01722214) patients who also underwent a pre-adalimumab FDG-PET scan for the study. Serum cytokine and chemokine levels in these samples will be measured; IL-17 and IL-22 using the Singulex immunoassay platform, and S100A9, IL-6 and TNF alpha using multiplex ELISA. Vascular inflammation will be measured as the target to background ratio (TBR) in the ascending aorta using PET-scan technology. Correlation analyses will be performed between serum levels of cytokines and a chemokine and vascular inflammation.

Keywords
Psoriasis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, PET scan, Cytokine, Chemokine
Medical subject headings
Psoriasis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02305953
Study groupRoleWhat they receive
Frozen serumThe cohort consists of original subjects from the Inno-6025 Trial who previously consented to measuring protein in the blood involved in skin inflammation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Secondary outcomes (1)

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

    Correlation between serum levels of a chemokine (S100A9) and vascular inflammation measured as TBR using FDG-PET in patients with moderate to severe psoriasis

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305953
Sponsor's protocol ID
Inno-6037
Status last verified
Nov 2014
First submitted
31 Oct 2014
Last updated
3 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Inflammation and Psoriasis, run by Innovaderm Research Inc. at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between serum cytokine levels (pg/mL) and TBR in the ascending aorta. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.

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