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Analysis Of The Influence Of Metabolic Syndrome On Treatment Efficacy With Anti-Tnf In Moderate-Severe Psoriasis In Real Clinical Practice.

12 mars 2014 uppdaterad av: Juan Ruano

CARDIOVASCULAR RISK FACTORS IN A SPANISH POPULATION OF PATIENTS WITH MODERATE-TO-SEVERE PSORIASIS VULGARIS, WITH OR WITHOUT ARTHRITIS, TREATED WITH ANTI-TNF IN REAL CLINICAL PRACTICE. ANALYSIS OF THE INFLUENCE OF METABOLIC SYNDROME ON TREATMENT EFFICACY.

It has been reported in various epidemiological studies that patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher prevalence of cardiovascular disease and mortality observed in this population. Existing evidence showing improvement in psoriasis after correcting some factors, such as obesity or hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk with different modalities of psoriasis treatment suggest a biological interaction between the two diseases beyond mere epidemiological association. Recently published results support this hypothesis and suggest that the link between psoriasis and cardiovascular disease could be the existence of an inflammatory state in different organs, including skin, joints, adipose and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk of developing T2DM and cardiovascular disease. This syndrome is characterized by the association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In recent years, a new mechanism participating in the development of MetS has been added: the Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been associated with metabolic abnormalities that predispose to cardiovascular disease, the development of moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, and response to treatment with anti-TNF-alpha.

This study aims to describe the cardiovascular risk factors of a Spanish population of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis,treated with anti-TNF under routine clinical practice conditions. Possible differences in efficacy relative to the presence or absence of criteria of metabolic syndrome will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first year.

Studieöversikt

Status

Okänd

Detaljerad beskrivning

  1. Eligibility criteria:

    1.1. Inclusion criteria:

    1. -Age >18 ys.
    2. -Male and female.
    3. -Moderate-to-severe psoriasis vulgaris, with or without psoriatic arthritis.
    4. -Treated with anti-TNF drugs (infliximab, etanercept, adalimumab). 1.2. Exclusion criteria:
    1. -Enrolled in another clinical trial.
    2. -Lack of clinical information at the hospital database.
  2. Objectives:

2.1. Primary objective: Evaluate the efficacy of anti-TNF- drugs in the treatment of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.

2.2. Secondary objectives:

  • 2.2.1. Analyze the possible modulatory role of genetic factors, such as Wnt pathway's gene polymorphisms, and other nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.
  • 2.2.2. Describe the cardiovascular risk factors in patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, treated with anti-TNF- in the Spanish population under routine clinical practice conditions.

Studietyp

Observationell

Inskrivning (Förväntat)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Cordoba, Spanien, 14004
        • Department of Dermatology. Reina Sofia University Hospital.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

-Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs at Reina Sofia University Hospital

Beskrivning

Inclusion Criteria:

  • Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs
  • Age >18 ys/<80 ys
  • With or without psoriatic arthritis

Exclusion Criteria:

  • Enrolled in another trial
  • Lack of clinical information
  • Pregnant

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Non-Metabolic Syndrome
Patients without Metabolic Syndrome criteria (OMS).
Metabolic Syndrome
Patients with Metabolic Syndrome criteria (OMS).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Role of Metabolic Syndrome on anti-TNF-drug efficacy.
Tidsram: After one year of treatment
Evaluate the efficacy of anti-TNF-drugs in themoderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.
After one year of treatment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy
Tidsram: First year of treament
Analyze the possible modulatory role of genetic factors, such as Wnt polymorphisms, and nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.
First year of treament

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cardiovascular disease factors
Tidsram: First year of treatment
Describe the cardiovascular risk factors in patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, treated with anti-TNF- in the Spanish population under routine clinical practice conditions.
First year of treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Samarbetspartners

Utredare

  • Huvudutredare: Juan Ruano, M.D., Ph.D., Ms. C., Departament of Dermatology. Reina Sofia University Hospital.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2012

Primärt slutförande (Förväntat)

1 april 2014

Avslutad studie (Förväntat)

1 juni 2014

Studieregistreringsdatum

Först inskickad

17 december 2012

Först inskickad som uppfyllde QC-kriterierna

19 december 2012

Första postat (Uppskatta)

20 december 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 mars 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 mars 2014

Senast verifierad

1 mars 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • JRR-ANT-2012-01 (Annan identifierare: Agencia Española de Medicamentos y Productos Sanitarios)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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