Tophaceous Gout Clinical Trial
Official title:
Open-label Study of Rituximab (RTX) Pretreatment Followed by Standard of Care (SOC) Methotrexate-Pegloticase (MTXPEG) to Treat Poorly Controlled Tophaceous Gout in Individuals With Prior Loss of Response to Pegloticase.
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.
Rituximab 1000 mg will be administered at week -6 and week -4 via intravenous infusion over the duration of 5 hours prior to Methotrexate-Pegloticase Standard-of-Care treatment. Per FDA approved dosing in the package insert, Rituximab infusion with concentration of 10 mg/mL will begin at 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hour increments every 30 minutes, to a maximum of 400 mg/hour or total dose of 1000 mg. All subjects will be treated with Methotrexate-Pegloticase Standard-of-Care with FDA-approved dosing of Pegloticase 8 mg IV infusion every 2 weeks, co-administered with methotrexate 15 mg orally once weekly (started 4 weeks prior to Pegloticase initiation). Standard-of-Care includes Pegloticase infusion every 2 weeks as long as clinically indicated (e.g., persistent tophus), concluding treatment when all tophaceous gout lesions resolve or up to 12-months, safety stop point, or subject withdrawal from the study. Subjects will be on study for up to 24 months. Screening visit: up to 28-days. Treatment visit: 1. Rituximab Pre-Treatment: up to 6-weeks + 1 week prior to Pegloticase treatment. (Pre-treatment of Rituximab will occur at -6 and -4 weeks.) 2. Methotrexate Treatment (Standard-of-Care): up to 6 weeks + 1 week prior to Pegloticase treatment. (Administered four weeks prior to Pegloticase and weekly during Pegloticase treatment). 3. Methotrexate-Pegloticase Study Treatment (Standard-of-Care): up to 12 months of Standard-of-Care. (Methotrexate is administered weekly and Pegloticase is coadministered every two weeks). Follow-up phone visits: up to 30 and 60 days after last dose of Methotrexate-Pegloticase + 7 days. Total subject participation duration is up to 24 months. Total study duration for recruitment, enrollment, and study completion of all subjects is up to 5 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03965676 -
Evolution of Tophus and Erosions of Hands and Feet at DECT
|
N/A | |
| Completed |
NCT01510769 -
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
|
Phase 3 |