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Enzyme Therapy

Pegloticase + Methotrexate Q2W for Gout

Q: In how many distinct clinics is this experimental investigation currently being conducted?

Enrollment for this research is ongoing at 18 distinct sites, including but not limited to Denver, Duncansville, and Chicago. Opting for a site in close proximity can reduce travel commitments when participating in the study.

Q: Is the enrollment process currently open for this research study?

Indeed, the details on clinicaltrials.gov affirm that this medical research is actively enrolling subjects. The trial was initially listed on 1/22/2024 and last revised on 3/21/2024. It aims to recruit a total of 240 participants spread across 18 locations.

Q: Has the combination of Pegloticase and Methotrexate every 4 weeks been granted approval by the FDA?

Our team at Power rates the safety of Pegloticase + Methotrexate Q4W as 3 on a scale from 1 to 3. This high rating is due to its approval status, being part of a Phase 4 trial.

Q: How large is the participant pool in this particular research endeavor?

Indeed, the details on clinicaltrials.gov affirm that this specific clinical trial is actively seeking individuals to participate. The study was initially listed on January 22nd, 2024, and most recently revised on March 21st of the same year. In total, the research aims to enroll 240 participants across a network of 18 locations.

Phase 4

Recruiting

Research Sponsored by Horizon Therapeutics Ireland DAC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

Study Summary

"This trial is comparing two different dosing schedules of pegloticase with methotrexate in patients with uncontrolled refractory gout. The main goal is to see if the higher dose of

Who is the study for?

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.Check my eligibility

What is being tested?

The study is testing whether giving Pegloticase every four weeks with Methotrexate (MTX) is as effective as every two weeks for reducing uric acid in gout patients. The first half is blinded, then all get the four-week treatment for another six months.See study design

What are the potential side effects?

Pegloticase can cause reactions like rash or pain at the injection site, nausea, headache, and possible flare-ups of gout symptoms. Methotrexate may lead to liver issues, mouth sores, low blood cell counts, and lung problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants achieving and maintaining serum uric acid (sUA) < 6 mg/dL at least 80% of the time

Secondary outcome measures

Proportion of Participants with complete resolution of ≥ 1 tophus

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pegloticase + Methotrexate Q4WExperimental Treatment2 Interventions

16 mg pegloticase will be administered intravenously every 4 weeks for 24 weeks during double blind treatment and 24 weeks during open label.

Group II: Pegloticase + Methotrexate Q2WExperimental Treatment2 Interventions

8 mg pegloticase will be administered intravenously every 2 weeks for 24 weeks during double blind treatment and 16 mg pegloticase every 4 weeks for 24 weeks during open label.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegloticase

2021

Completed Phase 4

~560

Methotrexate

2013

Completed Phase 4

~3800

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Horizon Therapeutics Ireland DACLead Sponsor

20 Previous Clinical Trials

2,236 Total Patients Enrolled

6 Trials studying Gout

438 Patients Enrolled for Gout

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct clinics is this experimental investigation currently being conducted?

"Enrollment for this research is ongoing at 18 distinct sites, including but not limited to Denver, Duncansville, and Chicago. Opting for a site in close proximity can reduce travel commitments when participating in the study."

Answered by AI

Is the enrollment process currently open for this research study?

"Indeed, the details on clinicaltrials.gov affirm that this medical research is actively enrolling subjects. The trial was initially listed on 1/22/2024 and last revised on 3/21/2024. It aims to recruit a total of 240 participants spread across 18 locations."

Answered by AI

Has the combination of Pegloticase and Methotrexate every 4 weeks been granted approval by the FDA?

"Our team at Power rates the safety of Pegloticase + Methotrexate Q4W as 3 on a scale from 1 to 3. This high rating is due to its approval status, being part of a Phase 4 trial."

Answered by AI

How large is the participant pool in this particular research endeavor?

"Indeed, the details on clinicaltrials.gov affirm that this specific clinical trial is actively seeking individuals to participate. The study was initially listed on January 22nd, 2024, and most recently revised on March 21st of the same year. In total, the research aims to enroll 240 participants across a network of 18 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229145.

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