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Clinical trial

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)

NCT06229145 is registered in ClinicalTrials.gov with Amgen as lead sponsor.

NCT NCT06229145
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)
Lead sponsor
Amgen
Phase
Phase 4
Overall status
Completed
Start date
March 18, 2024
Completion date
March 26, 2026
Enrollment
306 (actual)
Sites
74

Conditions

As the registry lists them; a condition with its own page is linked.

gout