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A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

Primary Purpose

Gout

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Puricase
Sponsored by
Savient Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring elevated uric acid, Elevated serum uric acid level, Symptomatic gout

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Spain Rehabilitation Center
  • University of California, San Diego
  • University of Chicago Dept of Medicine
  • Graves Gilbert Clinic
  • Center for Rheumatology and Bone Research
  • North Shore University Hospital Division of Rheumatology
  • Duke University Medical Center
  • Oregon Health & Science University Arthritis & Rheumatic Diseases
  • Pride Clinical research Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 24, 2004
Last Updated
May 31, 2013
Sponsor
Savient Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00080210
Brief Title
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
Official Title
A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Savient Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
elevated uric acid, Elevated serum uric acid level, Symptomatic gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Puricase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Spain Rehabilitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Chicago Dept of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
North Shore University Hospital Division of Rheumatology
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health & Science University Arthritis & Rheumatic Diseases
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pride Clinical research Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18759308
Citation
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.
Results Reference
derived

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A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

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