Re-Exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	May 6, 2008
Last Updated Date	October 27, 2008
Start Date ^ICMJE	May 2008
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 7, 2008)	evaluate the safety profile of pegloticase in this patient population [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00675103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 7, 2008)	clinical effect on quality of life, functional improvement,swollen and tender joints, and tophus burden [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Re-Exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Official Title ^ICMJE	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.
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Treatment Failure Gout
Intervention ^ICMJE	Drug: pegloticase 8 mg i.v.
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	18
Completion Date
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00675103
Responsible Party	Royce W. Waltrip II, MD, Senior Director, Clinical Research, Savient Pharmaceuticals
Study ID Numbers ^ICMJE	C0409
Study Sponsor ^ICMJE	Savient Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Savient Pharmaceuticals
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP