- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07793773
Disease Impact and Its Correlation With Disease Activity in Psoriatic Arthritis
Assessment of Disease Impact in Patients With Psoriatic Arthritis and Its Correlation With Disease Activity
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disorder that causes joint pain, stiffness, skin lesions, and functional disability, significantly affecting patients' quality of life. Patient-reported outcome measures (PROMs) provide essential insights into the impact of disease from the patient's perspective. The Psoriatic Arthritis Impact of Disease-12 (PsAID-12) questionnaire is a validated tool designed to evaluate 12 physical and psychological aspects of disease burden.
The main purpose of this cross-sectional study is to evaluate disease impact using the Arabic version of the PsAID-12 questionnaire and to investigate how disease impact correlates with clinical disease activity measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score in adult patients with PsA.
Participants will undergo routine clinical and rheumatological evaluations, including joint examinations (tender and swollen joint counts), laboratory tests (complete blood count, inflammatory markers such as ESR and CRP, liver and kidney function tests, and lipid profile), and plain radiography of affected joints (hands, feet, and sacroiliac joints). Patients will also complete the Arabic PsAID-12 questionnaire and patient global and pain assessments. All assessments will take place during a single evaluation visit at Assiut University Hospital.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients diagnosed with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria
- Age ≥ 18 years
- Willingness to participate in the study and provide informed consent
Exclusion Criteria:
- Patients younger than 18 years of age
- Presence of other coexisting autoimmune diseases
- Patients with advanced malignancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Psoriatic Arthritis Patients
Adult patients aged 18 years or older diagnosed with psoriatic arthritis fulfilling the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria who are attending the inpatient or outpatient clinics of the Rheumatology, Rehabilitation and Physical Medicine Department at Assiut University Hospital.
Patients undergo evaluation for disease impact using the Arabic 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire and assessment of disease activity via the Disease Activity in Psoriatic Arthritis (DAPSA) score.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Disease Impact Score Assessed by the Psoriatic Arthritis Impact of Disease (PsAID-12) Questionnaire
Periodo de tiempo: Baseline
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The Arabic version of the Psoriatic Arthritis Impact of Disease 12-item (PsAID-12) questionnaire is used to evaluate patient-reported disease impact.
It assesses 12 domains: pain, fatigue, skin problems, work and leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear, embarrassment/shame, social participation, and depression.
Each domain is scored on a numerical rating scale from 0 to 10, weighted, and aggregated into a total score ranging from 0 (no impact/best status) to 10 (extreme impact/worst status).
Higher total scores indicate greater negative disease impact.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades de la columna
- Espondiloartropatías
- Enfermedades De La Piel Papuloescamosa
- Enfermedades de la piel
- Espondiloartritis
- Espondilitis
- Soriasis
- Enfermedades de la piel y del tejido conectivo
- Artritis, Psoriásica
Otros números de identificación del estudio
- Psoriatic Arthritis Impact
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. .