Pegloticase + Methotrexate for Gout
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for this trial?
You will need to stop taking any oral urate-lowering therapy (ULT) for at least 7 days before starting methotrexate and continue not taking it during the trial. The protocol does not specify other medications, but you should discuss your current medications with the trial team.
Will I have to stop taking my current medications?
You will need to stop taking any oral uric acid-lowering therapy (ULT) for at least 7 days before starting methotrexate and continue not taking it during the trial. The protocol does not specify other medications, so it's best to discuss with the trial team.
What data supports the idea that Pegloticase + Methotrexate for Gout is an effective drug?
The available research shows that combining Pegloticase with Methotrexate improves the effectiveness of the treatment for gout. One study found that adding Methotrexate helps more patients respond to Pegloticase, increasing the response rate from 42% when Pegloticase is used alone. This combination helps prevent the body from developing antibodies that can make Pegloticase less effective. Another study confirmed these findings, showing that the combination is effective in patients with uncontrolled gout. This suggests that Pegloticase with Methotrexate is a more reliable option compared to using Pegloticase by itself.12345
What data supports the effectiveness of the drug Pegloticase combined with Methotrexate for treating gout?
What safety data is available for Pegloticase and Methotrexate treatment for gout?
Pegloticase, used for chronic refractory gout, has shown efficacy in reducing serum uric acid and improving joint function, but it is associated with a higher risk of adverse events, including infusion-related reactions and gout flares. Combining Pegloticase with Methotrexate may improve response durability by reducing antidrug antibody development. Clinical trials and studies, such as the MIRROR study, are exploring the safety and efficacy of this combination. However, infusion reactions remain a significant concern, and anti-inflammatory strategies may be needed to mitigate these effects.23467
Is the combination of Pegloticase and Methotrexate safe for treating gout?
Is the drug Pegloticase a promising treatment for gout?
How is the drug Pegloticase + Methotrexate unique for treating gout?
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
Adults over 18 with uncontrolled refractory gout, who have high uric acid levels and haven't responded to standard treatments. Participants must stop any oral gout medications before starting the trial and use contraception if necessary. Women of childbearing potential need negative pregnancy tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive pegloticase with methotrexate, either every 2 weeks or every 4 weeks, to evaluate non-inferiority in efficacy and safety
Open-label Extension
Participants receive pegloticase every 4 weeks with methotrexate in an open-label setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pegloticase
Pegloticase is already approved in United States, European Union for the following indications:
- Chronic gout in adult patients refractory to conventional therapy
- Disabling tophaceous gout
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Horizon Therapeutics Ireland DAC
Lead Sponsor