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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares GLP-1 medicines with nutrition counseling for people with psoriatic arthritis who also need treatment for obesity and type 2 diabetes. Psoriatic arthritis causes joint swelling and pain. Participants are assigned by chance to one treatment and have up to four study visits over 24 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and seen at a clinic for joint diseases.
  • Be able to read, understand, and give written consent to join.
  • Meet the study’s standard rules for diagnosing psoriatic arthritis.
  • Have a body mass index (BMI) of 30. BMI is a measure of weight compared with height.
  • Be getting treatment for psoriatic arthritis that follows care guidelines.
  • Still have more than a low level of arthritis symptoms and disease activity.
  • Have more than one tender joint at the start. A swollen joint count is also required, but the listing does not give the number.
  • Be able to take a GLP-1 medicine under FDA rules, as decided by the study doctor.

Who can't join

  • Have ever used a GLP-1 medicine.
  • Cannot give consent to join.
  • Are currently in another psoriatic arthritis study.
  • Have a reason that makes starting a GLP-1 medicine unsafe under FDA rules.
  • Have an HbA1c above 10 at the start. This blood test measures average blood sugar over time.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

WI