Phase 2 N=37 Treatment

Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

Gout

Bottom Line

View on ClinicalTrials.gov: NCT00111657 ↗

Enrolled (actual)

Serious AEs

13.3%

Results posted

Jan 2013

Primary outcome: Primary: Reduction in Plasma Uric Acid to Less Than 6 mg/dL. — 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pegloticase (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: John Sundy
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction in Plasma Uric Acid to Less Than 6 mg/dL.	17	—
SECONDARY Clinical Response: Number of Swollen and Tender Joints	13; 2; 9; 6	—
SECONDARY In a Subset of Subjects Who Volunteer Separately, Change in Uric Acid Pool Size Will be Assessed by a Method That Involves Infusion of Uric Acid Labeled With N15, a Stable (Nonradioactive) Isotope of Nitrogen.	—	—
SECONDARY Reduction of the Ratio of Uric Acid:Creatinine in Urine	—	—
SECONDARY Development of Antibodies to PEG-uricase	15	—
SECONDARY Infusion 1: Maximum Concentration (Cmax) Value	25.6	—
SECONDARY Infusion 1: Minimum Concentration (Cmin)	4.9	—

Summary

The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded adequately, to conventional therapy for gout. Funding Source - FDA OOPD

Eligibility Criteria

Inclusion Criteria

Age >18 years
Symptomatic gout
Serum uric acid >7 mg/dL
Intolerance of, or inadequate response to, conventional therapy for gout
Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method

Exclusion Criteria

End stage renal failure that requires dialysis
Concurrent use of uric-acid lowering agents
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
A history of anaphylactic reaction to a recombinant protein
Concurrent use of immunosuppressive therapy (except as needed for prevention of rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment of gout flares)
A medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00111657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.