Status: Recruiting
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
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.
Participants needed: 270
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: AmgenUpdated: Jul 2, 2026Locations: 55
Eligibility criteria
Participant has provided informed consent before initiation of any trial-specifi... [+3]
Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit). [+6]