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NCT06186219 · ClinicalTrials.gov registry record · Phase 1
Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT06186219: Completed Phase 1 study, sponsored by University of California, Los Angeles.
NCT06186219 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06186219, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This safety and feasibility, open-label study of up to 9 subjects will examine a group of subjects with poorly controlled tophaceous gout (intolerant to or ineffective oral urate lowering agents and loss of prior Pegloticase response) pre-treated with Rituximab to recapture response to Methotrexate-Pegloticase.
Primary Outcome
Simple descriptive statistics will be used to summarize toxicities in terms of type, severity and minimum or maximum values for laboratory measures, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects. Safety Analyses will be performed on Safety Analysis Set. After the first Pegloticase infusion, any subsequent pre-Pegloticase infusion lab result of serum urate \> 6 mg/dL will terminate the study.
Interventions
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2024-11-22 |
| Phase | Phase 1 |
What the finished NCT06186219 record still lists
NCT06186219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.
NCT06186219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06186219 about?
NCT06186219 is a clinical study titled "Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout". This safety and feasibility, open-label study of up to 9 subjects will examine a group of subjects with poorly controlled tophaceous gout (intolerant to or ineffective oral urate lowering agents and loss of prior Pegloticase response) pre-treated with Rituximab to recapture response to Methotrexate-...
What is the current status of trial NCT06186219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2024-04-10. Estimated completion is 2024-11-22.
What interventions are being tested in trial NCT06186219?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT06186219?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06186219's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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