Chronic Gout Refractory to Conventional Therapy
Conditions
Keywords
Gout, Gouty Arthritis, Anti-Gout preparations
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.
Interventions
DRUGpegloticase 8 mg i.v.
pegloticase 8 mg i.v. every 2 weeks for 24 weeks
Sponsors
Savient Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Profile | 6 months | Number of participants reporting events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegloticase 8 mg Every 2 Wks | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Pegloticase 8 mg Every 2 Wks |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 66.4 years STANDARD_DEVIATION 8.77 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 2 / — |
Outcome results
Primary
Adverse Event Profile
Number of participants reporting events
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegloticase 8 mg Every 2 Wks | Adverse Event Profile | Adverse Events | 7 Number of participants |
| Pegloticase 8 mg Every 2 Wks | Adverse Event Profile | Serious Adverse Events | 2 Number of participants |
Secondary
Mean Plasma Uric Acid
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
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegloticase 8 mg Every 2 Wks | Mean Plasma Uric Acid | Baseline | 8.5 mg/dL | Standard Deviation 1.21 |
| Pegloticase 8 mg Every 2 Wks | Mean Plasma Uric Acid | Week 3 | 4.0 mg/dL | Standard Deviation 2.63 |
| Pegloticase 8 mg Every 2 Wks | Mean Plasma Uric Acid | Week 7 | 7.7 mg/dL | Standard Deviation 5.61 |