Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)

25 de junio de 2012 actualizado por: Abbott

A Post-marketing Observational Study of the Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic DMARDs Over a Period of 1 Year (QUALITY)

The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

This was a non-interventional PMOS conducted in a prospective, single-country, multicenter format to assess the quality of life of psoriasis patients taking adalimumab as prescribed by their physician in accordance with the terms of the local marketing authorization with regard to dose, population, and indication. The prescription of adalimumab was clearly separated from the decision to include the participant in this study. No procedures other than standard of care were to have been performed. Visits were non-interventional and timing of participant appointments was left to each physician. After therapy initiation, visits occurred over 12 months usually close to Weeks 4, 12, 24, 36, and 52 for a total of 6 visits (Visits 1 through 6 including Screening). Because participant visits were left to the physician, participant failure to meet the suggested visit weeks did not constitute a breach of the protocol.

Tipo de estudio

De observación

Inscripción (Actual)

46

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Austria
      • Feldkirch, Austria, 6807
        • Site Reference ID/Investigator# 27435
      • Graz, Austria, 8010
        • Site Reference ID/Investigator# 27436
      • Graz, Austria, 8036
        • Site Reference ID/Investigator# 38445
      • Linz, Austria, 4020
        • Site Reference ID/Investigator# 27443
      • Vienna, Austria, 1030
        • Site Reference ID/Investigator# 27442
      • Vienna, Austria, 1130
        • Site Reference ID/Investigator# 27440
      • Vienna, Austria, 1160
        • Site Reference ID/Investigator# 27437
      • Vienna, Austria, A-1090
        • Site Reference ID/Investigator# 27439
      • Wels, Austria, 4600
        • Site Reference ID/Investigator# 23309

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Hospital, Dermatology

Descripción

Inclusion Criteria:

  • Patients for whom adalimumab therapy is indicated and has been prescribed according to the product label
  • Patients aged 18 years and older
  • Unsatisfactory response to prior BDMARDS (efalizumab, infliximab, etanercept) in patients with moderate to severe chronic plaque psoriasis or achievement of satisfactory response initially, but loss over time or discontinuation of treatment due to intolerance/side effects(s) or other reasons e.g. restart after regular stop of etanercept
  • Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in psoriasis (chest X-ray and purified protein derivative [PPD] skin test negative for tuberculosis)
  • Patient is willing to consent to data being collected and provided to Abbott
  • Patient must be able and willing to self-administer Pen injections or have a qualified person available to administer Pen injections

Exclusion Criteria:

  • Patients who meet contraindications as outlined in the latest version of the Humira-Pen Summary of Product Characteristics (SPC)
  • Patients who do not meet the criteria for the use of BDMARDs of the Austrian Treatment Recommendations
  • Patients participating in another study or clinical trial

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Adalimumab
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Psoriasis Area and Severity Index (PASI) Score
Periodo de tiempo: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Inclusion visit (Week 0), Week 4, Week 36, Week 52
Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)
Periodo de tiempo: Inclusion visit (Week 0) to Week 52
PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Inclusion visit (Week 0) to Week 52

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dermatology Life Quality Index (DLQI) Score
Periodo de tiempo: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).
Inclusion visit (Week 0), Week 4, Week 36, Week 52
Nail Psoriasis Severity Index (NAPSI) Score
Periodo de tiempo: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).
Inclusion visit (Week 0), Week 4, Week 36, and Week 52
Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions
Periodo de tiempo: From the time of participant consent until 70 days after last dose of study drug
Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.
From the time of participant consent until 70 days after last dose of study drug

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Abbott

Colaboradores

Assign Data Management and Biostatistics GmbH

Investigadores

  • Director de estudio: Astrid Dworan-Timler, MD, Abbott Austria

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2008

Finalización primaria (Actual)

1 de abril de 2011

Finalización del estudio (Actual)

1 de abril de 2011

Fechas de registro del estudio

Enviado por primera vez

28 de febrero de 2010

Primero enviado que cumplió con los criterios de control de calidad

9 de marzo de 2010

Publicado por primera vez (Estimar)

10 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

29 de junio de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2012

Última verificación

1 de junio de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • P10-708

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Psoriasis crónica

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Denmark

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir