Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06186219
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 10, 2024
Status verified
Apr 2024
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    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.

Primary Outcome Measure

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). [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CA

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