Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Savient Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01356498

First received: October 27, 2008

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 27, 2008

Last Updated Date

October 28, 2011

Start Date ^ICMJE

December 2006

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Uric Acid (mg/dL) [ Time Frame: Week 13, Week 25, Week 53, Week 101 ] [ Designated as safety issue: No ]

Uric acid measured at 3 month-intervals

Original Primary Outcome Measures ^ICMJE

Uric Acid (mg/dL) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Uric acid measured at 3 month-intervals

Change History

Complete list of historical versions of study NCT01356498 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tophus Response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.
Patient Reported Outcome: SF-36 Physical Component Summary Score [ Time Frame: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101 ] [ Designated as safety issue: No ]
SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).

The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.
Gout Flare Frequency [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
Gout Flare Incidence [ Time Frame: Assessed in 3-month intervals up to 2 years ] [ Designated as safety issue: Yes ]
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.

Original Secondary Outcome Measures ^ICMJE

Tophus Response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study
Patient Reported outcome: SF-36 Physical Component Summary Score [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to limitations in the dimensions related to physical function and pain.
Gout Flare Incidence and Frequency [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
The number of subjects reporting flares (flare frequency) and the mean number of flares per subject (flare frequency)were assessed over 3-month periods for up to 2 years of treatment

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

Official Title ^ICMJE

Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Brief Summary

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gout

Intervention ^ICMJE

Biological: pegloticase

8 mg intravenous infusion

Study Arm (s)

Experimental: q2 RCT
Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study

Intervention: Biological: pegloticase
Experimental: q4 RCT
Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study

Intervention: Biological: pegloticase
Experimental: Placebo in RCT
Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE

Intervention: Biological: pegloticase

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

151

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout

Exclusion Criteria:

unstable angina
uncontrolled arrhythmia
uncontrolled hypertension
end stage renal disease requiring dialysis
anemia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01356498

Other Study ID Numbers ^ICMJE

C0407

Has Data Monitoring Committee

Responsible Party

Savient Pharmaceuticals

Study Sponsor ^ICMJE

Savient Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director, M.D.

Savient Pharmaceuticals, Inc.

Information Provided By

Savient Pharmaceuticals

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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