Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
NCT07111494
Summary
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.
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Conditions2
Interventions1
Locations1 site
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NCT07111494