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Monoclonal Antibodies

Rituximab for Gout

Phase 1

Waitlist Available

Led By John FitzGerald, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Male or female ≥ 18 years of age at Baseline Visit

Prior discontinued use of Pegloticase due to failure or history of moderate to severe infusion reaction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the safety and feasibility of treating a group of people with a type of gout that is difficult to control. These individuals have not responded well to oral medications and have lost their response

Who is the study for?

This trial is for people with severe gout who can't take or haven't had success with standard oral treatments and have stopped responding to Pegloticase. They'll be given Rituximab before restarting Methotrexate-Pegloticase therapy.Check my eligibility

What is being tested?

The study is testing if giving Rituximab, an immune system-modifying drug, before resuming a combination of Methotrexate and Pegloticase helps patients with tough-to-treat gout respond better to treatment.See study design

What are the potential side effects?

Rituximab may cause side effects like infusion reactions (fever, chills), infections, heart problems, skin rashes, stomach issues, and muscle pains. The severity of these side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I stopped taking Pegloticase because it didn't work or caused a bad reaction.

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I have severe gout with high uric acid levels and ongoing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Neutralizing antibody titers (assays provided by Horizon labs) will be measured at Screening (Visit 0), prior to first Pegloticase infusion (Visit 3, Week 0), Visit 9, Week 12 and Visit 16, Week 26.

The study will be measured by the frequency and grade of adverse event (AEs) (solicited and unsolicited), serious adverse experience (SAEs), adverse event of special interest (AESI1s), medically attended adverse events (MAAEs).

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Trial Design

1Treatment groups

Experimental Treatment

Group I: RituximabExperimental Treatment1 Intervention

Rituximab 1000 mg will be administered at week -6 and week -4 via intravenous infusion over the duration of 5 hours prior to the Pegloticase (Standard-of-Care) treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,193 Total Patients Enrolled

1 Trials studying Gout

15 Patients Enrolled for Gout

John FitzGerald, MDPrincipal InvestigatorUniversity of California, Los Angeles

1 Previous Clinical Trials

15 Total Patients Enrolled

1 Trials studying Gout

15 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.

Are there ongoing efforts to actively enroll participants for this medical study?

"According to the data available on clinicaltrials.gov, this particular clinical trial is no longer actively recruiting patients. The original posting date was January 31st, 2024, and it was last updated on December 15th, 2023. However, there are currently other ongoing studies that are actively seeking participants with a total of 30 opportunities available."

Answered by AI

Has the Food and Drug Administration granted its approval for the use of Rituximab?

"Rituximab's safety is currently assessed as level 1 by our team at Power, considering it is a Phase 1 trial with limited data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout

John D. Fitzgerald, MD, PhD 2024. "Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186219.

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