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Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00675103
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Savient Pharmaceuticals

Study Description
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Brief Summary:

The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.


Condition or disease Intervention/treatment Phase
Chronic Gout Refractory to Conventional Therapy Drug: pegloticase 8 mg i.v. Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
Study Start Date : May 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Pegloticase

Arms and Interventions
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Arm Intervention/treatment
Experimental: pegloticase Drug: pegloticase 8 mg i.v.
pegloticase 8 mg i.v. every 2 weeks for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Event Profile [ Time Frame: 6 months ]
    Number of participants reporting events


Secondary Outcome Measures :
  1. Mean Plasma Uric Acid [ Time Frame: Baseline, Week 3 and Week 7 ]
    This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous treatment in studies of pegloticase i.v.
  • Last exposure to pegloticase i.v. greater than one year prior to study entry
  • Symptomatic gout
  • Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria:

  • Prior exposure to Elitek® (rasburicase)
  • Unstable angina
  • Uncontrolled arrhythmia or hypertension
  • Non-compensated congestive heart failure
  • End stage renal disease requiring dialysis
  • Concomitant use of SUA lowering agents and use of other investigational drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675103


Locations
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United States, Illinois
University of Chicago- Dept. Biological Services
Chicago, Illinois, United States, 60637
United States, Maryland
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Portland Rheumatology Clinic, L.L.C.
Lake Oswego, Oregon, United States, 97035
Sponsors and Collaborators
Savient Pharmaceuticals
More Information
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Responsible Party: Chief Medical Officer, Savient Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00675103    
Other Study ID Numbers: C0409
First Posted: May 8, 2008    Key Record Dates
Results First Posted: June 28, 2011
Last Update Posted: June 28, 2011
Last Verified: June 2011
Keywords provided by Savient Pharmaceuticals:
Gout
Gouty Arthritis
Anti-Gout preparations
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
 Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases