Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout (EyesOnGOUT)

Horizon Therapeutics

Status: Completed

Conditions: Refractory Chronic Gout

Treatments: Biological: Pegloticase

Study type: Observational

Funder types: Industry

Identifiers

NCT01466166

M0401

Details and patient eligibility

About

The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.

Full description

This was a Phase 4, multicenter, open-label, single-arm observational study of pegloticase 8 mg administered intravenously every 2 weeks in adult hyperuricemic patients with gout refractory to conventional therapy. Study duration is approximately 63 weeks, including 51 weeks of treatment and 12 weeks of follow-up.

The design of this study follows the FDA-approved Full Prescribing Information for the use of pegloticase and allows for capturing additional data related to the safety and efficacy of pegloticase within the standard healthcare setting.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated.
• Patients who have made the decision, along with their treating physician, to begin treatment with KRYSTEXXA.
• Patients who are willing and able to give informed consent and adhere to visit/protocol schedules.

Exclusion criteria

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Non-compensated congestive heart failure
• Pregnancy or breast feeding
• Prior treatment with pegloticase or another recombinant uricase
• Known allergy to urate oxidase
• Prior treatment or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug
• Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study

Trial design

188 participants in 1 patient group

Pegloticase

Description:

Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.

Treatment:

Biological: Pegloticase