Pegloticase

BIOLOGICAL14 trials

Sponsors

John Sundy, Savient Pharmaceuticals, Horizon Pharma Rheumatology LLC, Ampel BioSolutions, LLC, Amgen

Conditions

Chronic GoutChronic Kidney Disease Stage 5GoutHematopoietic and Lymphoid Cell NeoplasmKidney TransplantMalignant Solid NeoplasmRefractory Chronic GoutTumor Lysis Syndrome

Phase 1

Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis

CompletedNCT01739660

Savient PharmaceuticalsChronic Kidney Disease Stage 5

Start: 2012-12-31End: 2013-04-30Updated: 2013-10-25

Phase 2

Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

CompletedNCT00111657

Start: 2004-12-31End: 2009-07-31Updated: 2014-10-03

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

CompletedNCT02598596

Ampel BioSolutions, LLCGout

Start: 2015-12-31End: 2020-04-27Updated: 2021-10-11

Phase 3

Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

CompletedNCT00325195

Savient PharmaceuticalsGout

Start: 2006-05-31End: 2007-12-31Updated: 2011-02-28

Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

CompletedNCT01356498

Savient PharmaceuticalsGout

Start: 2006-12-31End: 2010-01-31Updated: 2011-12-02

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

RecruitingNCT07388498

AmgenUncontrolled Gout

Start: 2026-02-09End: 2028-07-18Target: 270Updated: 2026-03-31

Phase 4

Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout

CompletedNCT03635957

Start: 2018-09-26End: 2020-10-26Updated: 2024-06-26

Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

CompletedNCT03994731

Start: 2019-06-13End: 2022-04-11Updated: 2024-06-26

Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant

CompletedNCT04087720

AmgenKidney Transplant, Uncontrolled Gout

Start: 2019-09-09End: 2021-09-07Updated: 2024-06-26

Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome

Active, not recruitingNCT04745910

M.D. Anderson Cancer CenterHematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Tumor Lysis Syndrome

Start: 2022-04-05End: 2026-07-31Updated: 2025-12-18

A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)

CompletedNCT04762498

AmgenChronic Gout, Uncontrolled Gout

Start: 2021-01-26End: 2023-12-20Updated: 2025-10-01

Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy

CompletedNCT04772313

AmgenUncontrolled Gout

Start: 2021-03-08End: 2023-04-24Updated: 2024-06-27

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Active, not recruitingNCT06229145

Start: 2024-03-18End: 2026-03-12Updated: 2026-01-02

Unknown Phase

Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout

CompletedNCT01466166

Horizon Pharma Rheumatology LLCRefractory Chronic Gout

Start: 2011-11-15End: 2017-06-30Updated: 2019-01-11

Related Papers

Gout Remission With Pegloticase‐Induced Intensive Urate‐Lowering Therapy: A Post Hoc Clinical Trial Analysis

ACR Open Rheumatology2025-08-01

Monosodium Urate Crystal Depletion and Bone Erosion Response in Kidney Transplant Recipients With Uncontrolled Gout Treated With Pegloticase: PROTECT Serial Dual-Energy Computed Tomography Findings

Transplantation Direct2025-05-12

Treatment-emergent major adverse cardiovascular and thromboembolic events were infrequent during clinical trials of pegloticase

Lara D. Veeken2025-01-101 citations

Quality of life and clinical gout assessments during pegloticase with and without methotrexate co-therapy: MIRROR randomized controlled trial exploratory findings.

2024-11-29

Monosodium urate crystal depletion and bone erosion remodeling during pegloticase treatment in patients with uncontrolled gout: Exploratory dual-energy computed tomography findings from MIRROR RCT

Joint Bone Spine2024-03-049 citations

Pegloticase efficacy and safety in kidney transplant recipients; results of the phase IV, open-label PROTECT clinical trial.

2023-05-035 citations

Improved joint and patient-reported health assessments with pegloticase plus methotrexate co-therapy in patients with uncontrolled gout: 12-month exploratory outcomes of the MIRROR open-label trial

Arthritis Research & Therapy2022-12-279 citations

A multicentre, efficacy and safety study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase (MIRROR): 12-month efficacy, safety, immunogenicity, and pharmacokinetic findings during long-term extension of an open-label study.

2022-08-258 citations

Dual-energy CT assessment of rapid monosodium urate depletion and bone erosion remodelling during pegloticase plus methotrexate co-therapy

Lara D. Veeken2022-03-1625 citations

Pegloticase in Combination With Methotrexate in Patients With Uncontrolled Gout: A Multicenter, Open-label Study (MIRROR)

The Journal of Rheumatology2020-09-1563 citations

Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase

The Journal of Rheumatology2019-06-155 citations

Pegloticase Treatment Significantly Decreases Blood Pressure in Patients With Chronic Gout

Hypertension2019-05-1336 citations

Induced and pre-existing anti-polyethylene glycol antibody in a trial of every 3-week dosing of pegloticase for refractory gout, including in organ transplant recipients

Arthritis Research & Therapy2014-03-07262 citations

Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout

Arthritis Research & Therapy2014-03-04254 citations

Effect of pegloticase on renal function in patients with chronic kidney disease: a post hoc subgroup analysis of 2 randomized, placebo-controlled, phase 3 clinical trials

BMC Research Notes2014-01-0131 citations

Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy.

2013-09-2671 citations

Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials.

2011-08-01362 citations