Status:
COMPLETED
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
Lead Sponsor:
Horizon Pharma Rheumatology LLC
Conditions:
Refractory Chronic Gout
Eligibility:
All Genders
18+ years
Brief Summary
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, anaphyla...
Detailed 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 convent...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT01466166
Start Date
November 15 2011
End Date
June 30 2017
Last Update
January 11 2019
Active Locations (67)
Enter a location and click search to find clinical trials sorted by distance.
1
Rheumatology Associates, PC
Birmingham, Alabama, United States, 35205
2
UAB Rheumatology
Birmingham, Alabama, United States, 35294
3
Saadat Ansari, MD, LLC
Huntsville, Alabama, United States, 35801
4
Medvin Clinical Research
Covina, California, United States, 91723