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ADVANCE: Pegloticase + MTX Retreatment in Uncontrolled Gout
NCT04772313Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2021
- Primary completion
- Aug 2022
- Countries
- 1
- Sponsor
- Amgen
- Modality
- Replacement Enzymes
- Drugs
- pegloticase
- Conditions
- gout
01
Overview
Phase 4, open-label, single-arm trial of pegloticase in gout, sponsored by Amgen. Primary endpoint: Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6. Started Mar 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Pegloticase + MTX
Pegloticase 8mg IV q2w + Methotrexate SC weekly
03
Who it enrols
Adults with uncontrolled gout (sUA >= 6 mg/dL) who previously failed pegloticase monotherapy without severe infusion reaction. Must tolerate MTX run-in.
04
Endpoints
Primary
Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Secondary
Percentage of sUA Responders (sUA < 6 mg/dL) During Month 3
Percentage of Participants Who Experienced Infusion Reaction, Anaphylaxis, or sUA Discontinuation Criteria
Mean Change From Baseline in Urate Deposition Volume Measured by DECT
Mean Change From Baseline in Health Assessment Questionnaire - Disability Index
Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Pain Score
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