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NCT07111494
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Conditions: Psoriatic Arthritis (PsA)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 22
Sponsor: Medical College of Wisconsin
Location: Medical College of Wisconsin/Froedtert Hosptial Milwaukee Wisconsin
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 Criteria
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
Source: ClinicalTrials.gov (NCT07111494). StuddyBuddy aggregates publicly available trial information.