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Clinical Trial NCT07111494 for Psoriatic Arthritis (PsA) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial Phase 4 22 Randomized
Clinical Trial NCT07111494 is designed to study Treatment for Psoriatic Arthritis (PsA). This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on October 15, 2025 until the study accrues 22 participants. Led by Medical College of Wisconsin, this study is expected to complete by October 15, 2028. The latest data from ClinicalTrials.gov was last updated on August 13, 2025.
Brief 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...Show More
Official Title
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Conditions
Psoriatic Arthritis (PsA)Other Study IDs
- PRO55130
NCT ID Number
Start Date (Actual)
2025-10-15
Last Update Posted
2025-08-13
Completion Date (Estimated)
2028-10-15
Enrollment (Estimated)
22
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Psoriatic Arthritis
GLP-1
Minimal Disease Activity
Nutrition Counseling
GLP-1
Minimal Disease Activity
Nutrition Counseling
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGLP-1 | GLP-1 agonists GLP-1, any assigned drug |
Active ComparatorNutrition Counseling | Nutrition Counseling Nutrition Counseling in PsA |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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 WisconsinStudy Responsible Party
Shikha Singla, Principal Investigator, Associate Professor, Medical College of Wisconsin
No contact data.
1 Study Locations in 1 Countries
Wisconsin
Medical College of Wisconsin/Froedtert Hosptial, Milwaukee, Wisconsin, 53226, United States
Shikha Singla, MD, Contact, 414-955-7040, [email protected]
Kiley Timler, Contact, [email protected]
Shikha Singla, MD, Principal Investigator
David Gazeley, MD, Sub-Investigator
Michael Putman, MD, Sub-Investigator
Lisa Morseli, MD, Sub-Investigator
Ann Rosenthal, MD, Sub-Investigator
Anam Qureshi, MD, Sub-Investigator