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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 Randomizado

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07111494 vai avaliar tratamento para Artrite psoriásica (APs). Este é um estudo intervencionista de Fase IV. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 15 de outubro de 2025, com o objetivo de incluir 22 participantes. Coordenado por Medical College of Wisconsin e deve ser concluído em 15 de outubro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de agosto de 2025.
Resumo
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 mais
Título oficial

Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial

Condições médicas
Artrite psoriásica (APs)
Outros IDs do estudo
  • PRO55130
Número NCT
NCT07111494
Data de início (real)
2025-10-15
Última atualização postada
2025-08-13
Data de conclusão (estimada)
2028-10-15
Inscrição (estimada)
22
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Ainda não recrutando
Palavras-chave
Psoriatic Arthritis
GLP-1
Minimal Disease Activity
Nutrition Counseling
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador ativoGLP-1
GLP-1 agonists
GLP-1, any assigned drug
Comparador ativoNutrition Counseling
Aconselhamento nutricional
Nutrition Counseling in PsA
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
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 Wisconsin logoMedical College of Wisconsin
Responsável pelo estudo
Shikha Singla, Investigador principal, Associate Professor, Medical College of Wisconsin
Sem dados de contato.
1 Locais do estudo em 1 países

Wisconsin

Medical College of Wisconsin/Froedtert Hosptial, Milwaukee, Wisconsin, 53226, United States
Shikha Singla, MD, Contato, 414-955-7040, [email protected]
Kiley Timler, Contato, [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