Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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