A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
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Phase
Phase 4
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
262actual
Sites
74
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-18 | actual | When the study began enrolling |
| Primary completion | 2025-07-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-11 | actual | The whole study's end, after follow-up |
| First posted | 2024-01-29 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-01 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Gout
Interventions
- Biological: Pegloticase — also filed as Krystexxa
- Drug: Methotrexate
Primary outcome
what the primary-completion date above is the date OFPercentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
measured Month 6 (Weeks 20, 21, 22, 23, and 24)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-03-06 · 8.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-08-20 · 591 KB · SAP_001.pdf
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