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Die klinische Studie NCT07111494 für Psoriasis-Arthritis (PsA) ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial Phase 4 22 Randomisiert
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Die klinische Studie NCT07111494 untersucht Behandlung im Zusammenhang mit Psoriasis-Arthritis (PsA). Diese interventionsstudie der Phase 4 hat den Status noch nicht rekrutierend. Der Start ist für 15. Oktober 2025 geplant, bis 22 Teilnehmer aufgenommen werden. Durchgeführt von Medical College of Wisconsin wird der Abschluss für 15. Oktober 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 13. August 2025 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Erkrankungen
Psoriasis-Arthritis (PsA)Weitere Studien-IDs
- PRO55130
NCT-Nummer
Studienbeginn (tatsächlich)
2025-10-15
Zuletzt aktualisiert
2025-08-13
Studienende (vorauss.)
2028-10-15
Geplante Rekrutierung
22
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Noch nicht rekrutierend
Stichwörter
Psoriatic Arthritis
GLP-1
Minimal Disease Activity
Nutrition Counseling
GLP-1
Minimal Disease Activity
Nutrition Counseling
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives VergleichspräparatGLP-1 | GLP-1 agonists GLP-1, any assigned drug |
Aktives VergleichspräparatNutrition Counseling | Ernährungsberatung Nutrition Counseling in PsA |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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 WisconsinVerantwortliche Partei
Shikha Singla, Hauptprüfer, Associate Professor, Medical College of Wisconsin
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Wisconsin
Medical College of Wisconsin/Froedtert Hosptial, Milwaukee, Wisconsin, 53226, United States
Shikha Singla, MD, Kontakt, 414-955-7040, [email protected]
Kiley Timler, Kontakt, [email protected]
Shikha Singla, MD, Hauptprüfer
David Gazeley, MD, Prüfarzt
Michael Putman, MD, Prüfarzt
Lisa Morseli, MD, Prüfarzt
Ann Rosenthal, MD, Prüfarzt
Anam Qureshi, MD, Prüfarzt