Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

April 10, 2024

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2027

Conditions
Tophaceous Gout
Interventions
DRUG

Rituximab

"Rituximab is a monoclonal antibody that targets cluster of differentiate 20 (CD20) present on B-cells and lowers humoral immunity. Rituximab has been used successfully as a desensitization agent to treat Highly Human Leukocyte Antigens (HLA)-sensitized patients planning renal transplant. All cases of antibody-mediated rejection were seen in the placebo group, none in the Rituximab group. Rituximab has been safely used with Methotrexate in the treatment of Rheumatoid Arthritis, where co-administration of Methotrexate and Rituximab results in better outcomes than either medication alone.~We propose this safety and feasibility open-label trial that will examine if Rituximab pre-treatment before Standard-of-Care Methotrexate-Pegloticase will result in recapture of Pegloticase efficacy as measured by serum urate (SU) \< 6 mg/dL throughout the trial and up to 6-months of Methotrexate-Pegloticase administration."

Trial Locations (1)

90095

UCLA, Los Angeles

All Listed Sponsors
lead

University of California, Los Angeles

OTHER