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

• Sponsor: Savient Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00675103
• Collaborator: (none)
• Enrollment: 7
• Locations: 4
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

• Study Type: Interventional
• 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 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pegloticase	Drug: pegloticase 8 mg i.v.; pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Outcome Measures

Primary Outcome Measures

1. Adverse Event Profile [6 months]

   Number of participants reporting events

Secondary Outcome Measures

1. Mean Plasma Uric Acid [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago- Dept. Biological Services	Chicago	Illinois	United States	60637
2	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
3	Duke University Medical Center	Durham	North Carolina	United States	27710
4	Portland Rheumatology Clinic, L.L.C.	Lake Oswego	Oregon	United States	97035

Sponsors and Collaborators

• Savient Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00675103
• Other Study ID Numbers: C0409
• First Posted: May 8, 2008
• Last Update Posted: Jun 28, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Gout; Gouty Arthritis; Anti-Gout preparations
• Additional relevant MeSH terms: Gout

Study Results

Participant Flow

Arm/Group Title	Pegloticase 8 mg Every 2 Wks
Arm/Group Description
Period Title: Overall Study
STARTED	7
COMPLETED	4
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Pegloticase 8 mg Every 2 Wks
Arm/Group Description
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 57.1%
>=65 years	3 42.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.4 (8.77)
Sex: Female, Male (Count of Participants)
Female	1 14.3%
Male	6 85.7%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Adverse Event Profile
Description	Number of participants reporting events
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pegloticase 8 mg Every 2 Wks
Arm/Group Description
Measure Participants	7
Adverse Events	7 100%
Serious Adverse Events	2 28.6%

2. Secondary Outcome

Title	Mean Plasma Uric Acid
Description	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.
Time Frame	Baseline, Week 3 and Week 7

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Pegloticase 8 mg Every 2 Wks
Arm/Group Description
Measure Participants	7
Baseline	8.5 (1.21)
Week 3	4.0 (2.63)
Week 7	7.7 (5.61)

Adverse Events

Time Frame	6 months
Arm/Group Title	Pegloticase 8 mg Every 2 Wks
Arm/Group Description
All Cause Mortality
	Pegloticase 8 mg Every 2 Wks
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pegloticase 8 mg Every 2 Wks
	Affected / at Risk (%)	# Events
Total	2/ (NaN)
Infections and infestations
Cellulitis	1/7 (14.3%)	1
Metabolism and nutrition disorders
Hyperglycaemia	1/7 (14.3%)	1
Other (Not Including Serious) Adverse Events
	Pegloticase 8 mg Every 2 Wks
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Gastrointestinal disorders
Vomiting	1/7 (14.3%)
General disorders
Infusion-Related Reaction	4/7 (57.1%)	7
Fatigue	1/7 (14.3%)
Oedema Peripheral	1/7 (14.3%)
Nausea	1/7 (14.3%)
Infections and infestations
Upper Respiratory Tract Infection	1/7 (14.3%)
Injury, poisoning and procedural complications
Procedural Pain	1/7 (14.3%)
Metabolism and nutrition disorders
Diabete Mellitus Non-Insulin Dependent	1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Gout (flare)	5/7 (71.4%)
Arthralgia	2/7 (28.6%)
Back Pain	1/7 (14.3%)
Shoulder Pain	1/7 (14.3%)
New Tophus	1/7 (14.3%)
Nervous system disorders
Tremor	1/7 (14.3%)
Renal and urinary disorders
Polyuria	1/7 (14.3%)
Skin and subcutaneous tissue disorders
Rash	1/7 (14.3%)
Surgical and medical procedures
Wound Drainage	1/7 (14.3%)
Vascular disorders
Hypertension	1/7 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.