A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
1 other identifier
interventional
40
1 country
9
Brief Summary
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2004
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 24, 2004
CompletedFirst Posted
Study publicly available on registry
March 25, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedJune 3, 2013
May 1, 2013
March 24, 2004
May 31, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects to be included in the study are:
- Outpatients of either gender, age 18 or older
- Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
- Hyperuricemic: screening serum uric acid must be \>=8 mg/dL.
- The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
- Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide
You may not qualify if:
- Subjects to be excluded are those for whom any of the following apply:
- Unstable coronary artery disease or uncontrolled hypertension
- History of end stage renal disease requiring dialysis
- History of liver disease, as defined by baseline serum transaminase elevation \>3X the upper limit of normal in the absence of any other known cause
- Organ transplant recipient requiring immunosuppressive therapy
- Concurrent use of prednisone at a dose \>10 mg qd (or equivalent) at or within one week before dosing
- Concurrent use of uric acid-lowering agents
- Prior treatment with Puricase® or other recombinant uricase
- An acute gout flare within one week prior to first treatment with Puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol
- glucose-6-phosphate dehydrogenase deficiency
- A history of anaphylactic reaction to a recombinant protein or porcine derivatives
- Lactation
- Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
- Known allergy to urate oxidase or PEGylated products
- Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Spain Rehabilitation Center
Birmingham, Alabama, 35294, United States
University of California, San Diego
La Jolla, California, 92037, United States
University of Chicago Dept of Medicine
Chicago, Illinois, 60637, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
North Shore University Hospital Division of Rheumatology
Manhasset, New York, 11030, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oregon Health & Science University Arthritis & Rheumatic Diseases
Portland, Oregon, 97239, United States
Pride Clinical research Associates
Pittsburgh, Pennsylvania, 15219, United States
Related Publications (1)
Sundy JS, Becker MA, Baraf HS, Barkhuizen A, Moreland LW, Huang W, Waltrip RW 2nd, Maroli AN, Horowitz Z; Pegloticase Phase 2 Study Investigators. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum. 2008 Sep;58(9):2882-91. doi: 10.1002/art.23810.
PMID: 18759308DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2004
First Posted
March 25, 2004
Study Start
March 1, 2004
Study Completion
February 1, 2005
Last Updated
June 3, 2013
Record last verified: 2013-05