A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With M… (NCT06229145) | Clinical Trial Compass
CompletedPhase 4
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
United States262 participantsStarted 2024-03-18
Plain-language summary
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout.
The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult men or women ≥ 18 years of age
✓. Uncontrolled gout, defined as meeting the following criteria:
✓. Willing to discontinue any oral ULT for at least 7 days prior to MTX dosing at Week -4 and continue not receiving any oral ULT when receiving pegloticase/placebo for pegloticase infusions
✓. Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4.
✓. Men who are not vasectomized must agree to use appropriate contraception, so as to not impregnate a female partner of reproductive potential during the trial.
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 (3 months or longer)
✕. History of any transplant surgery requiring maintenance immunosuppressive therapy
What they're measuring
1
Evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time
✕. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity
✕. Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative
✕. Known history of human immunodeficiency virus (HIV) positivity
✕. G6PD deficiency (quantitative test at the Screening Visit centrally or locally)
✕. Non-compensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina) or uncontrolled blood pressure (\> 160/100 mmHg) prior to Week -4