Rituximab for Gout

Recruiting in Palo Alto (17 mi)

Overseen byJohn FitzGerald, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This safety and feasibility, open-label study of up to 9 subjects will examine a group of subjects with poorly controlled tophaceous gout (intolerant to or ineffective oral urate lowering agents and loss of prior Pegloticase response) pre-treated with Rituximab to recapture response to Methotrexate-Pegloticase.

Eligibility Criteria

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.

Inclusion Criteria

Meets the American College of Rheumatology Classification Criteria for Gout

I agree to stop my gout medication 7 days before starting Pegloticase treatment.

I am 18 years old or older.

+5 more

Exclusion Criteria

Pregnant, planning to become pregnant, breastfeeding, or not on an effective form of birth control

Anaphylaxis or other prior severe infusion reaction to Pegloticase

Abnormal blood cell counts

+23 more

Participant Groups

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.

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.

Rituximab is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Rituxan for: