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Product

Pegloticase

Name
Krystexxa
INN Name
pegloticase
FDA Approved
Yes

7 clinical trials

1 organization

5 indications

1 document

Indication
Gout
Indication
Hematopoietic and Lymphoid Cell Neoplasm
Indication
Malignant Solid Neoplasm
Indication
Tumor Lysis Syndrome
Indication
Kidney Transplant
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)
Status: Recruiting, Estimated PCD: 2025-09-01
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])
Status: Completed, Estimated PCD: 2021-03-17
Clinical trial
A Phase 4, Multicenter, Open-label, Efficacy and Safety Trial of Pegloticase and Methotrexate Co-administered in Patients With Uncontrolled Gout Who Have Previously Received Pegloticase Monotherapy But Did Not Maintain a Serum Uric Acid Response
Status: Completed, Estimated PCD: 2022-08-23
Clinical trial
Effect of Pegloticase on Reduction of Uric Acid in Patients With Tumor Lysis Syndrome: A Pilot Pragmatic Clinical Trial
Status: Recruiting, Estimated PCD: 2025-12-31
Clinical trial
A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Status: Completed, Estimated PCD: 2024-01-18
Clinical trial
A Phase 4, Open-Label, Multicenter, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout (FORWARD Open-Label [OL] Trial)
Status: Completed, Estimated PCD: 2023-05-18
Clinical trial
A Multicenter, Open-Label, Efficacy and Safety Study of Pegloticase in Patients With Uncontrolled Gout Who Have Undergone Kidney Transplantation
Status: Completed, Estimated PCD: 2021-07-06
Document
DailyMed Label: Krystexxa
Organization
Horizon Therapeutics USA, Inc.