Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout (EyesOnGOUT)
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|ClinicalTrials.gov Identifier: NCT01466166|
Recruitment Status : Completed
First Posted : November 6, 2011
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment|
|Refractory Chronic Gout||Biological: Pegloticase|
This was a Phase 4, multicenter, open-label, single-arm observational study of pegloticase 8 mg administered intravenously every 2 weeks in adult hyperuricemic patients with gout refractory to conventional therapy. Study duration is approximately 63 weeks, including 51 weeks of treatment and 12 weeks of follow-up.
The design of this study follows the FDA-approved Full Prescribing Information for the use of pegloticase and allows for capturing additional data related to the safety and efficacy of pegloticase within the standard healthcare setting.
|Study Type :||Observational|
|Actual Enrollment :||188 participants|
|Official Title:||Observational Study of the Use of KRYSTEXXA® (Pegloticase) in Adult Hyperuricemic Patients With Gout Refractory to Conventional Therapy|
|Actual Study Start Date :||November 15, 2011|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.
Pegloticase 8 mg intravenous every 2 weeks
Other Name: KRYSTEXXA®
- Number of Participants With Infusion Reactions [ Time Frame: 52 weeks ]Infusion reactions were defined as adverse events (AEs) or clusters of events, not attributable to another cause that occurred during or within 2 hours after the infusion of pegloticase. Any other case that occurred outside of the 2-hour window was categorized per Investigator discretion.
- Number of Participants With Anaphylaxis [ Time Frame: 52 weeks ]
Anaphylaxis was defined using the National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives; pruritus or flushing; swollen lips, tongue, or uvula), and at least 1 of the following:
- Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia).
- Reduced blood pressure (i.e., systolic blood pressure < 90 mm Hg or greater than 30% decrease from that patient's baseline) or associated symptoms of end-organ failure (e.g., hypotonia [collapse], syncope, incontinence).
- Number of Participants With Immune Complex-related Events [ Time Frame: From first dose of study drug to the end of the 12-week follow-up period (63 weeks). ]Immune complex-related events were defined as any presumptive immune complex-related disorders that were confirmed by an appropriate investigation of the event and of complement markers (C3 and C4 levels). Clinical manifestations could have included skin rash, arthralgia, arthritis, proteinuria, serum sickness, and cryoglobulinemia.
- Percentage of Participants With Normalization of Serum Uric Acid at Week 24 and Week 52 [ Time Frame: Week 24 and week 52 ]Normalization of serum uric acid was defined as serum uric acid value less than 6 mg/dL.
- Change From Baseline in Number of Gout Flares [ Time Frame: Baseline, week 24 and week 48 ]The number of gout flares occurring in the 2 weeks prior to each visit. Baseline number of flares was calculated as the average number of flares that occurred in the 6-month baseline period divided by 12 weeks.
- Number of Swollen Joints Over Time [ Time Frame: Baseline and weeks 24 and 52 ]
- Number of Tender Joints Over Time [ Time Frame: Baseline and weeks 24 and 52 ]
- Number of Palpable Tophi Over Time [ Time Frame: Baseline and weeks 24 and 52 ]Gout tophi are nodular deposits of urate crystals and inflammatory cells in joints, soft tissues, bones, and in some organs.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466166
|Study Director:||Jeffery Nieves, PharmD||Horizon Pharma Rheumatology LLC|