ClinicalTrials.gg
RecruitingNCT06887452Pham-UPUpdated Oct 21, 2026

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

An interventional study of Pharmacist-Led in Gout and Gouty Arthritis, sponsored by VA Office of Research and Development. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Primary conditionArthritis, GoutyRegistry: GoutReclassifiedWhy we changed it
Registry
Gout — the first condition term the registry derived for this study.
ClinicalTrials.gg
Arthritis, Gouty
Why
  1. The study's listed conditions name Arthritis, Gouty, a narrower term within Gout.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 21, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Gout
  • Gouty Arthritis

Browse trials for

03

In context

Arthritis, Gouty Reclassified

47 studies on the registry are indexed under Arthritis, Gouty; 16 are open to participants now.

This study's planned enrollment of 310 is above the median of 140 across 35 interventional studies indexed under Arthritis, Gouty.

Browse Arthritis, Gouty studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Compared within Arthritis, Gouty, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gout. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

The criteria were revised on the registry on Oct 21, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 \< 12 months
  • Patients with a concomitant medication of azathioprine or 6-MPC (urate-lowering therapy )
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
310 participants (estimated)

Study arms

  • 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

  • No intervention
    Usual care

    Veterans will receive standard care from their primary care provider for the management of their gout.

Interventions

  • OtherPharmacist-Led

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

06

What researchers measure

Primary outcomes

  1. flare occurrence

    The occurrence of two or more flares during year 2.

    Time frame: during year two

  2. serum urate at goal

    Achievement of serum urate \<6 milligrams per deciliter (mg/dL) at end of year one.

    Time frame: at end of year one

Secondary outcomes

  1. 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.

    Time frame: Baseline visit, Months 6, 12, 18, and 24

  2. 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).

    Time frame: Baseline visit, Months 6, 12, 18, and 24

  3. 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.

    Time frame: Baseline visit, Months 6, 12, 18, and 24

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Oct 2029, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2025
First posted
Mar 20, 2025
StartActual
Oct 1, 2026
Primary completionEst.
Oct 1, 2029
CompletionEst.
Mar 30, 2031
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 21, 2026
Sites
5 sites changed recruiting status (5 now recruiting)
Show 5 sites
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE · Omaha, United Statesno status→Recruiting
  • VA Portland Health Care System, Portland, OR · Portland, United Statesno status→Recruiting
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA · Philadelphia, United Statesno status→Recruiting
  • VA Salt Lake City Health Care System, Salt Lake City, UT · Salt Lake City, United Statesno status→Recruiting
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA · Seattle, United Statesno status→Recruiting
Oct 21, 2026
Eligibility
4 inclusion criteria edited; 1 exclusion criterion edited, 4 added
What changed in the criteria
Inclusion criteria
  • EditedUS Veterans over the age of 18 years with physician-diagnosed
  • EditedDocumented hyperuricemia (SU > 6.8 mg/dLmilligrams per deciliter)
  • EditedSatisfy American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria
  • EditedReceipt 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
Exclusion criteria
  • EditedAny patient intolerant or unable to take ULTsurate-lowering therapies (allopurinol or febuxostat)
  • AddedPatients on an allopurinol dose > 300 or a Febuxostat dose > 40
  • AddedPatients with stage IV/V Chronic Kidney Disease (CKD)
  • AddedPatients with a life expectancy < 12 months
  • AddedPatients with a concomitant medication of azathioprine or 6-MPC (urate-lowering therapy contraindicated)
Oct 21, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • Descriptionserum urate at goal: how it is measured was reworded
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Not yet recruiting→Recruiting
    5 sites changed recruiting status (5 now recruiting)
    Show 5 sites
    • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE · Omaha, United Statesno status→Recruiting
    • VA Portland Health Care System, Portland, OR · Portland, United Statesno status→Recruiting
    • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA · Philadelphia, United Statesno status→Recruiting
    • VA Salt Lake City Health Care System, Salt Lake City, UT · Salt Lake City, United Statesno status→Recruiting
    • VA Puget Sound Health Care System Seattle Division, Seattle, WA · Seattle, United Statesno status→Recruiting
    Eligibility 4 inclusion criteria edited; 1 exclusion criterion edited, 4 added
    What changed in the criteria
    Inclusion criteria
    • EditedUS Veterans over the age of 18 years with physician-diagnosed
    • EditedDocumented hyperuricemia (SU > 6.8 mg/dLmilligrams per deciliter)
    • EditedSatisfy American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria
    • EditedReceipt 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
    Exclusion criteria
    • EditedAny patient intolerant or unable to take ULTsurate-lowering therapies (allopurinol or febuxostat)
    • AddedPatients on an allopurinol dose > 300 or a Febuxostat dose > 40
    • AddedPatients with stage IV/V Chronic Kidney Disease (CKD)
    • AddedPatients with a life expectancy < 12 months
    • AddedPatients with a concomitant medication of azathioprine or 6-MPC (urate-lowering therapy contraindicated)
    Primary outcomes 1 description edited
    What changed in the outcomes
    • Descriptionserum urate at goal: how it is measured was reworded
    + 4 other changes: identifiers, verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06887452
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Oct 1, 2026
Primary completion
Oct 1, 2029 (estimated)
Completion
Mar 30, 2031 (estimated)
Last update
Oct 21, 2026

Study contacts

Bridget Kramer
Contact
bridget.kramer@va.gov
(402) 995-3206
Ted R. Mikuls
principal investigator · Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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