{"id":"pegloticase-with-mtx","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Gout flares"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Chest pain"},{"rate":null,"effect":"Anaphylaxis"}]},"_chembl":{"chemblId":"CHEMBL1237025","moleculeType":"Enzyme"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pegloticase catalyzes the oxidation of uric acid to allantoin, a more soluble compound that is readily excreted. The addition of methotrexate as an immunosuppressant helps prevent the development of antibodies against the pegylated enzyme, which can reduce drug efficacy and increase infusion reactions. This combination approach allows for sustained uric acid lowering in patients with severe, refractory gout.","oneSentence":"Pegloticase is a pegylated uricase enzyme that breaks down uric acid into allantoin, while methotrexate (MTX) is added to reduce anti-drug antibody formation and improve tolerability.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:23:03.585Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic gout refractory to conventional urate-lowering therapy"}]},"trialDetails":[{"nctId":"NCT07388498","phase":"PHASE3","title":"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","status":"RECRUITING","sponsor":"Amgen","startDate":"2026-02-09","conditions":"Uncontrolled Gout","enrollment":270},{"nctId":"NCT06229145","phase":"PHASE4","title":"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","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2024-03-18","conditions":"Gout","enrollment":262},{"nctId":"NCT04511702","phase":"PHASE4","title":"Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate","status":"COMPLETED","sponsor":"Amgen","startDate":"2020-10-02","conditions":"Chronic Uncontrolled Gout, Gout, Uncontrolled Gout","enrollment":191},{"nctId":"NCT04762498","phase":"PHASE4","title":"A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)","status":"COMPLETED","sponsor":"Amgen","startDate":"2021-01-26","conditions":"Uncontrolled Gout, Chronic Gout","enrollment":50},{"nctId":"NCT04772313","phase":"PHASE4","title":"Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy","status":"COMPLETED","sponsor":"Amgen","startDate":"2021-03-08","conditions":"Uncontrolled Gout","enrollment":11},{"nctId":"NCT03635957","phase":"PHASE4","title":"Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-09-26","conditions":"Gout","enrollment":14},{"nctId":"NCT03994731","phase":"PHASE4","title":"Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout","status":"COMPLETED","sponsor":"Amgen","startDate":"2019-06-13","conditions":"Gout","enrollment":152}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Methotrexate"],"phase":"marketed","status":"active","brandName":"Pegloticase with MTX","genericName":"Pegloticase with MTX","companyName":"Amgen","companyId":"amgen","modality":"Biologic","firstApprovalDate":"","aiSummary":"Pegloticase is a pegylated uricase enzyme that breaks down uric acid into allantoin, while methotrexate (MTX) is added to reduce anti-drug antibody formation and improve tolerability. Used for Chronic gout refractory to conventional urate-lowering therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}