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

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

This study is currently recruiting participants.
Verified by Savient Pharmaceuticals, May 2008

Sponsored by:	Savient Pharmaceuticals
Information provided by:	Savient Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00675103

Purpose

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.

Condition	Intervention	Phase
Treatment Failure Gout	Drug: pegloticase 8 mg i.v.	Phase III

MedlinePlus related topics:

Gout

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:

evaluate the safety profile of pegloticase in this patient population [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical effect on quality of life, functional improvement,swollen and tender joints, and tophus burden [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	May 2008

Intervention Details:

pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675103

Contacts


Contact: Debra Merritt	732-565-4733

Contact: Claudia D Rehrig, M.S.	732-565-4738

Locations


United States, Maryland
	The Center for Rheumatology and Bone Research	Recruiting
	Wheaton, Maryland, United States, 20902
	Principal Investigator: Herbert Baraf, M.D.

United States, Oregon
	Portland Rheumatology Clinic, L.L.C.	Recruiting
	Lake Oswego, Oregon, United States, 97035
	Contact: Andre Barkhuizen, M.D.
	Principal Investigator: Andre Barkhuizen, M.D.

Sponsors and Collaborators

Savient Pharmaceuticals

More Information

Responsible Party:	Savient Pharmaceuticals ( Royce W. Waltrip II, MD, Senior Director, Clinical Research )
Study ID Numbers:	C0409
First Received:	May 6, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00675103
Health Authority:	United States: Food and Drug Administration