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NCT Number: NCT07111494

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

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.

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Key information

Conditions

Psoriatic Arthritis (PsA) Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical College of Wisconsin/Froedtert Hosptial

Milwaukee, Wisconsin, 53226, United States

Location contact

Anam Qureshi, MD

SUB_INVESTIGATOR

Ann Rosenthal, MD

SUB_INVESTIGATOR

David Gazeley, MD

SUB_INVESTIGATOR

Kiley Timler

CONTACT

[email protected]

Lisa Morseli, MD

SUB_INVESTIGATOR

Michael Putman, MD

SUB_INVESTIGATOR

Shikha Singla, MD

CONTACT

[email protected]

414-955-7040

Shikha Singla, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1 agonists

Drug

GLP-1, any assigned drug

Nutrition Counseling

Other

Nutrition Counseling in PsA

Primary outcomes

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

Time frame: Week 12 and 24

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.
Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2028
First posted: Aug 8, 2025
Registry last updated: Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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