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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

Must not have

Glucose-6-phosphate dehydrogenase deficiency

Treatment for acute coronary syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a G6PD deficiency.

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I am receiving treatment for a recent heart attack or severe chest pain.

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I frequently suffer from severe bacterial infections.

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I have had a transplant and am on drugs to suppress my immune system.

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I am HIV positive.

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Methotrexate is not suitable for me due to health reasons.

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I haven't taken any experimental drugs recently and won't during the study.

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I have a long-term liver condition.

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I have a lung condition like pulmonary fibrosis or bronchiectasis.

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My kidney function is very low or I am on dialysis.

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My blood pressure is not controlled before starting Rituximab.

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I am currently undergoing treatment for my cancer.

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I am currently receiving treatment for a cancer that is not skin cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2990

0 / 16Eligibility criteria met