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El ensayo clínico NCT07111494 para Artritis psoriásica (APs) está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial Fase IV 22 Aleatorizado
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El ensayo clínico NCT07111494 está diseñado para estudiar el tratamiento de Artritis psoriásica (APs). Este es un estudio intervencionista de Fase IV. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 15 de octubre de 2025 hasta completar 22 participantes. Dirigido por Medical College of Wisconsin, se espera que finalice el 15 de octubre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de agosto de 2025.
Resumen
Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2...Mostrar más
Título oficial
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Condiciones médicas
Artritis psoriásica (APs)Otros ID del estudio
- PRO55130
Número del NCT
Inicio del estudio (real)
2025-10-15
Última actualización
2025-08-13
Fecha de finalización (estimada)
2028-10-15
Inscripción (prevista)
22
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Aún no recluta
Palabras clave
Psoriatic Arthritis
GLP-1
Minimal Disease Activity
Nutrition Counseling
GLP-1
Minimal Disease Activity
Nutrition Counseling
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activoGLP-1 | GLP-1 agonists GLP-1, any assigned drug |
Comparador activoNutrition Counseling | Asesoramiento nutricional Nutrition Counseling in PsA |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition Counseling | In order to meet Minimal Disease Activity (MDA) participants need to meet 5 of the 7 criteria: tender joint count less than or equal to 68 and greater than or equal to 1 (TJC68), swollen joint count less than or equal to 66 and greater than or equal to 1 (SJC66), psoriasis body surface area is less than or equal to 3%, patient pain Visual Analogue Scale (VAS) is less than or equal to 15mm, patient global disease activity VAS is less than or equal to 20mm, Health Assessment Questionnaire (HAQ) is less than or equal to 0.5 and tender entheseal points is less than or equal to 1. One of the outcomes of this study is to see how these scores change with the participants receiving a GLP-1 or nutrition counseling. | Week 12 and 24 |
Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24 | DASPA is a composite measure based on the summation of four variables: tender and swollen joints (TJC68, SJC66), C-reactive protein (CRP), Patient Global Assessment (PtGA) and Patient Pain both reported on a 0-100 mm VAS. DASPA classifications validated for PsA include Less than or equal to 4 (remission), greater than 4 but less than or equal to 14 is low disease activity. Greater than 14 but less than or equal to 28 is moderate disease activity and greater than 28 is high disease activity. | Week 12 and 24 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Adult patients (age 18 and older) who present to rheumatology clinic
- Participants must be able to read, understand, and provide documented informed consent as approved by the Institutional Review Board (IRB).
- Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA
- Participants must have a Body Mass Index (BMI) of 30kg/m^2
- Participants must be treated for PsA in accordance with guidelines
- Have not achieved MDA in PsA patients
- Have a minimum TJC > 1 and SJC > at baseline
- Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator.
- Any prior use of GLP-1 agonists
- Inability to provide informed consent
- Current participation in another PsA study
- Treatment initiation by GLP-1 agonists contraindicated by FDA
- Patients with hemoglobin A1c (HbA1c) > 10 at baseline
Medical College of WisconsinParte responsable del estudio
Shikha Singla, Investigador principal, Associate Professor, Medical College of Wisconsin
No hay datos de contacto.
1 Centros del estudio en 1 países
Wisconsin
Medical College of Wisconsin/Froedtert Hosptial, Milwaukee, Wisconsin, 53226, United States
Shikha Singla, MD, Contacto, 414-955-7040, [email protected]
Kiley Timler, Contacto, [email protected]
Shikha Singla, MD, Investigador principal
David Gazeley, MD, Subinvestigador
Michael Putman, MD, Subinvestigador
Lisa Morseli, MD, Subinvestigador
Ann Rosenthal, MD, Subinvestigador
Anam Qureshi, MD, Subinvestigador