Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout (Pham-UP)

February 17, 2026 updated by: VA Office of Research and Development

Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study

This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).

Study Type

Interventional

Enrollment (Estimated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68105-1850
        • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
        • Contact:
        • Principal Investigator:
          • Ted R. Mikuls
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • VA Portland Health Care System, Portland, OR
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4551
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84148-0001
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • US Veterans over the age of 18 years with physician-diagnosed
  • Documented hyperuricemia (SU >6.8 mg/dL)
  • Satisfy ACR/EULAR gout classification criteria
  • Report 1 or more flares in the prior 6 months
  • Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria

Exclusion Criteria:

  • Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
  • Patients with a rheumatology encounter within the prior 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist-Led
Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment.
Other: Pharmacist-Led
Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment
No Intervention: Usual care
Veterans will receive standard care from their primary care provider for the management of their gout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
flare occurrence
Time Frame: during year two
The occurrence of two or more flares during year 2.
during year two
serum urate at goal
Time Frame: at end of year one
Achievement of serum urate <6 mg/dL at end of year one.
at end of year one

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Veterans RAND 12 (VR-12)
Time Frame: Baseline visit, Months 6, 12, 18, and 24
Quality of life instrument to assess components of physical and mental health. The survey asks about a patient's views on their health. The information will keep track of how a patient feels and how well they are able to do their usual activities. Scores include ranking their health from excellent to poor, whether physical or emotional health or pain limits activities or accomplishments, whether their health interferes with social activities and lastly asks patients to compare their physical and emotional health to one year ago. The scales range from not-at-all through all the time.
Baseline visit, Months 6, 12, 18, and 24
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: Baseline visit, Months 6, 12, 18, and 24
Survey to assess pain on relevant aspects of a patient's life within the last 7 days. The survey asks whether or not pain interfered with enjoyment, concentration, outside-of-home tasks, and socialization. The scale is at a not at all (1) through very much (5).
Baseline visit, Months 6, 12, 18, and 24
Gout-related patient global assessment
Time Frame: Baseline visit, Months 6, 12, 18, and 24
Participants will complete a rating scale on all the ways gout affects them on a 0-100 scale ranging from very well to very poor.
Baseline visit, Months 6, 12, 18, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Ted R. Mikuls, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

March 30, 2031

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMA-005-24F
  • CX002995 (Other Grant/Funding Number: VA CSR&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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