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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

Study comparing Pegloticase treatments for gout: every 4 weeks vs. 2 weeks.

Recruiting
18 years and older
All
Phase 4

This is a study for people with uncontrolled refractory gout, a condition where your body has too much uric acid, leading to painful joint swelling. The study tests two different ways to give a medicine called pegloticase with methotrexate (MTX). Pegloticase helps lower uric acid, and MTX is used to help the body accept pegloticase. The study lasts for 48 weeks, with the first 24 weeks being double-blind (neither you nor the doctor knows which treatment you get), followed by 24 weeks where everyone knows the treatment. The goal is to see if taking pegloticase every four weeks is as effective as taking it every two weeks.

  • Length: 48 weeks total with regular clinic visits.
  • Eligibility: Adults 18+ with uncontrolled gout and not on certain medications.
  • Risks: Possible side effects from pegloticase and MTX.

Participants must stop other gout medicines before starting and meet certain health criteria. If you have certain serious health conditions, this study might not be for you. Women must not be pregnant, and men should use birth control to avoid pregnancy during the study.

Study details
    Gout

NCT06229145

Amgen

28 December 2024

Step 1 Get in touch with the nearest study center
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