A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
Amgen
Summary
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participant has provided informed consent before initiation of any trial-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. * Participants with uncontrolled gout, as meeting the protocol defined criteria. Exclusion Criteria * Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit). * Liver transaminase levels (aspartate aminotransferase \[AST\] or alanine aminotr…
Interventions
- DrugPegloticase
Participants will receive pegloticase either SC or IV.
- DrugMethotrexate
MTX will be administered orally.
Locations (37)
- Solace Clinical ResearchTustin, California
- Denver Arthritis Clinic PCDenver, Colorado
- D and H Pompano Research CenterAventura, Florida
- New Generation of Medical ResearchHialeah, Florida
- Homestead Associates In Research IncHomestead, Florida
- Well Pharma Medical Research CorpMiami, Florida