Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusio… (NCT04511702) | Clinical Trial Compass
CompletedPhase 4
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
United States191 participantsStarted 2020-10-02
Plain-language summary
The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult men or women ≥18 years of age.
✓. Uncontrolled gout, defined as meeting the following criteria:
✓. Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX dosing at Week -4 and remain off of urate lowering therapy when receiving pegloticase infusions during the study.
Exclusion criteria
✕. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
✕. Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (defined as 3 months or longer) would also meet exclusion criteria.
✕. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit).
✕. Severe chronic renal impairment (estimated glomerular filtration rate \<40 mL/min/1.73 m2) at the Screening Visit based on 4 variable-Modification of Diet in Renal Disease \[MDRD\] formula or currently on dialysis.
✕. Non-compensated congestive heart failure or hospitalization for congestive heart failure or treatment for acute coronary syndrome (myocardial infarction or unstable angina) within 3 months of the Screening Visit, or current uncontrolled arrhythmia, or current uncontrolled blood pressure (BP) (\>160/100 mmHg) prior to Week -4.
✕. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner, or not on an effective form of birth control, as determined by the Investigator.
What they're measuring
1
Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24
✕. Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug.
✕. Currently receiving systemic or radiologic treatment for ongoing cancer.