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Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study (MMAPPS)

15. März 2017 aktualisiert von: Steven K. Grinspoon, MD, Massachusetts General Hospital
The main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease cardiovascular inflammation.

Studienübersicht

Status

Beendet

Bedingungen

Detaillierte Beschreibung

Psoriasis is a common disease characterized by skin lesions and systemic inflammation with or without arthritis. Patients with psoriasis have a higher risk of cardiovascular disease than healthy subjects, and this may be related in part to the inflammatory nature of their disease. This study is intended to help provide explanations for the increased cardiovascular disease risk in psoriasis and to assess whether this risk can be reduced by biologic anti-inflammatory therapies prescribed to resolve skin lesions and arthritis.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

29

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Massachusetts General Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Subjects with moderate-to-severe psoriasis with or without arthritis will be recruited primarily from dermatology and rheumatology clinics in the eastern Massachusetts area.

Beschreibung

FOR PSORIASIS PATIENTS

Inclusion Criteria:

-men and women age 18-80 with moderate-to-severe psoriasis (with or without arthritis) newly initiating biologic therapy with etanercept (enbrel) 50 mg once or twice weekly

Exclusion Criteria:

  • pregnancy or breastfeeding
  • women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
  • history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease other than psoriasis or a related psoriatic condition
  • previous therapy for psoriasis with a biologic agent within the past 4 months
  • new initiation of a statin or antihyperglycemic agent within the past 3 months
  • screening hemoglobin < 11
  • conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an eGFR by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (uninterruptable administration of phosphodiesterase inhibitors), body weight greater than 320 lbs (PET scanner table limitation)

  • report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:

    • more than 2 myocardial perfusion studies within the past 12 months
    • more than 2 CT angiograms within the past 12 months
  • concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding

FOR HEALTHY CONTROL SUBJECTS

Inclusion Criteria:

-men and women age 18-80 without psoriasis

Exclusion Criteria:

  • pregnancy or breastfeeding
  • women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
  • history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease
  • screening hemoglobin < 11
  • conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an estimated creatinine clearance by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (e.g. continuous administration of phosphodiesterase inhibitors), body weight greater than 320 lbs PET scanner table limitation)

  • report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:

    • more than 2 myocardial perfusion studies within the past 12 months
    • more than 2 CT angiograms within the past 12 months
  • concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Healthy control subjects
Healthy control subjects matched to psoriasis patients on traditional cardiovascular risk factors will be studied at baseline.
Psoriasis patients starting etanercept
Patients with moderate to severe psoriasis with or without arthritis who are about to be started on etanercept (enbrel) by their treating clinicians will be studied at baseline and 3 months after etanercept therapy.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Burden of aortic/coronary atherosclerotic plaque as measured by MDCT coronary angiography.
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Morphology of the aortic/coronary atherosclerotic plaque (e.g. calcification score, vulnerability characteristics) as measured by MDCT coronary angiography.
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Endothelial function as measured by flow-mediated vasodilation.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Oral glucose tolerance.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Blood sugar and insulin levels during a standard 2-hour oral glucose tolerance test.
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Lipid and lipoprotein levels.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, and apolipoprotein E.
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Inflammatory biomarker levels.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Levels of inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein, interleukin-6, and TNF-alpha.
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Body fat distribution.
Zeitfenster: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Measurements of height, weight, waist-to-hip ratio, leg circumference, arm circumference, and neck circumference. Determinations by whole body DEXA scanning of the total body and regional percent fat and lean body mass. Determination by single-slice abdominal computed tomography of total fat area, visceral adipose tissue, and subcutaneous adipose tissue.
Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Massachusetts General Hospital

Mitarbeiter

Immunex Corporation

Ermittler

  • Hauptermittler: Steven K Grinspoon, MD, Massachusetts General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2012

Primärer Abschluss (Tatsächlich)

1. Januar 2016

Studienabschluss (Tatsächlich)

1. Januar 2016

Studienanmeldedaten

Zuerst eingereicht

29. Dezember 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Januar 2012

Zuerst gepostet (Schätzen)

1. Februar 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. März 2017

Zuletzt verifiziert

1. März 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2011P-000557

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