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NCT03303989 · ClinicalTrials.gov registry record · Phase 2
REduCing Immunogenicity to PegloticasE (RECIPE) Study
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT03303989: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT03303989 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03303989, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.
Primary Outcome
Proportion of participants achieving and maintaining an sUA ≤ to 6 mg/dL through 12 weeks, compared to concurrent controls.
Interventions
- DRUG Placebo
- DRUG MMF
- DRUG Pegloticase 8 MG/ML [Krystexxa]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 2 |
What the finished NCT03303989 record still lists
NCT03303989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03303989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03303989 about?
NCT03303989 is a clinical study titled "REduCing Immunogenicity to PegloticasE (RECIPE) Study". Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly...
What is the current status of trial NCT03303989?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2018-06-14. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT03303989?
The interventions under investigation include: Placebo (DRUG), MMF (DRUG), Pegloticase 8 MG/ML [Krystexxa] (DRUG).
Who is sponsoring clinical trial NCT03303989?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03303989's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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