Набор скоро начнётся NCT07111494

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

Фаза IV С лечением Psoriatic Arthritis (PsA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: GLP-1 agonists, Nutrition Counseling.
Кому может быть актуально: Состояния в реестре: Psoriatic Arthritis (PsA). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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 diabetes. The main objectives it aims to answer are: To assess disease outcomes of PsA patients undergoing treatment for concomitant obesity and type 2 diabetes with GLP-1 analogs vs nutrition counseling. To assess effectiveness as measured by clinical and patient reported outcome measures in patients treated with GLP-1 and nutrition counseling. Participants will be randomized to receive a GLP-1 or nutrition counseling. Participants will be asked to come to the study center at most four times during a 24-week period. During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn.

Вмешательства

Препарат GLP-1 agonists
GLP-1, any assigned drug
Другое Nutrition Counseling
Nutrition Counseling in PsA

Первичные конечные точки

Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition Counseling [Срок оценки: 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 [Срок оценки: Week 12 and 24]

Критерии участия

Критерии включения

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.