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NCT Number: NCT06887452

Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

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.

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Key information

Conditions

Gout Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gouty Arthritis Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, Nebraska, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pharmacist-Led

Other

Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment

Primary outcomes

  1. flare occurrence

    Time frame: during year two

    The occurrence of two or more flares during year 2.

  2. serum urate at goal

    Time frame: at end of year one

    Achievement of serum urate <6 mg/dL at end of year one.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bridget Kramer

CONTACT

[email protected]

(402) 995-3206

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: Pham-UP

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Mar 20, 2025
Registry last updated
Feb 19, 2026

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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