GoutPham-UPNCT06887452
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
A study testing Pharmacist-Led in people with Gout and Gouty Arthritis, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Gouty Arthritis
- What is being tested?
- Pharmacist-Led
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2026to 30 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- US Veterans with physician-diagnosed
- Documented hyperuricemia (SU > 6.8 milligrams per deciliter)
- Satisfy American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria
- Report 1 or more flares in the prior 6 months
- Receipt of a new urate-lowering therapy (ULT) prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria
Who cannot join
- Any patient intolerant or unable to take urate-lowering therapies (allopurinol or febuxostat)
- Patients with a rheumatology encounter within the prior 3 months
- Patients on an allopurinol dose > 300 or a Febuxostat dose > 40
- Patients with stage IV/V Chronic Kidney Disease (CKD)
- Patients with a life expectancy < 12 months
- Patients with a concomitant medication of azathioprine or 6-MPC (urate-lowering therapy contraindicated)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Bridget Kramer, (402) 995-3206, bridget.kramer@va.gov
Ted R. Mikuls
- Recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Criswell Lavery, MPH, 215-823-5800, criswell.lavery@va.gov
- Recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Alexandra Bennett, 503-220-8262 ext. 52472, alexandra.bennett@va.gov
- Recruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Jennifer Godina, jennifer.godina1@va.gov
- Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Hannah Brubeck, 206-764-2673, hannah.brubeck@va.gov
About this study
Official title: 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.
Read the 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).
- Conditions
- Gout, Gouty Arthritis
- Being tested
- Pharmacist-Led
- Medical subject headings
- Gout, Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-LedOther
Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-Led | Experimental | Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment. Receives: Other: Pharmacist-Led |
| Usual care | No intervention | Veterans will receive standard care from their primary care provider for the management of their gout. |
What is being measured
The primary outcome is the main question the study is designed to answer.
flare occurrence
The occurrence of two or more flares during year 2.
Measured: during year two
serum urate at goal
Achievement of serum urate <6 milligrams per deciliter (mg/dL) at end of year one.
Measured: at end of year one
Secondary outcomes (3)
Veterans RAND 12 (VR-12)
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.
Measured: Baseline visit, Months 6, 12, 18, and 24
Patient Reported Outcomes Measurement Information System (PROMIS)
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).
Measured: Baseline visit, Months 6, 12, 18, and 24
Gout-related patient global assessment
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.
Measured: Baseline visit, Months 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Oct 2026
- Primary completion1 Oct 2029 (estimated)
- Study completion30 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ted R. Mikuls, Principal investigator, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887452
- Sponsor's protocol ID
- IMMA-005-24F
- Other IDs
- 1I01CX002995-01, CX002995
- Acronym
- Pham-UP
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study
- ClinicalTrials.gov ID
- NCT06887452
- Acronym / sponsor ID
- Pham-UP / IMMA-005-24F
- Conditions
- Gout, Gouty Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 30 Mar 2031 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized multicenter, parallel-group study that will compare a pharmacist-led / telehealth delivered intervention to usual care in gout management
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-Led | Experimental | Other: Pharmacist-LedVeterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment. |
| Usual care | No intervention | –Veterans will receive standard care from their primary care provider for the management of their gout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- US Veterans with physician-diagnosed
- Documented hyperuricemia (SU > 6.8 milligrams per deciliter)
- Satisfy American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria
- Report 1 or more flares in the prior 6 months
- Receipt of a new urate-lowering therapy (ULT) prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria
Key exclusion criteria (6 listed)
- Any patient intolerant or unable to take urate-lowering therapies (allopurinol or febuxostat)
- Patients with a rheumatology encounter within the prior 3 months
- Patients on an allopurinol dose > 300 or a Febuxostat dose > 40
- Patients with stage IV/V Chronic Kidney Disease (CKD)
- Patients with a life expectancy < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-LedPharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment | Other | Pharmacist-Led |
Primary outcome
flare occurrence
Time frame: during year two
The occurrence of two or more flares during year 2.
serum urate at goal
Time frame: at end of year one
Achievement of serum urate <6 milligrams per deciliter (mg/dL) at end of year one.
3 secondary outcomes
Veterans RAND 12 (VR-12)
Time frame: 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
Gout-related patient global assessment
Time frame: Baseline visit, Months 6, 12, 18, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ted R. Mikuls principal investigator
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Led in people with Gout and Gouty Arthritis, run by VA Office of Research and Development at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridget Kramer ((402) 995-3206, bridget.kramer@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flare occurrence (time frame: during year two). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.