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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07111494
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Psoriatic Arthritis (PsA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GLP-1 agonists — DRUG
    GLP-1, any assigned drug
  • Nutrition Counseling — OTHER
    Nutrition Counseling in PsA

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Aug 2025
Primary completion
Oct 15, 2026
Completion
Oct 15, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GLP-1
  • Active Comparator: Nutrition Counseling

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of Wisconsin/Froedtert HosptialMilwaukeeWisconsin53226
Shikha Singla, MD
[email protected]
414-955-7040
Kiley Timler
[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)

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By research site
Medical College of Wisconsin/Froedtert Hosptial· Milwaukee, WI

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