N/A
N=188
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
Refractory Chronic Gout
Bottom Line
View on ClinicalTrials.gov: NCT01466166 ↗Enrolled (actual)
188
Serious AEs
16.5%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Infusion Reactions — 42 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pegloticase (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Horizon Pharma Rheumatology LLC
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Infusion Reactions |
42 | — |
| PRIMARY Number of Participants With Anaphylaxis |
5 | — |
| PRIMARY Number of Participants With Immune Complex-related Events |
3 | — |
| SECONDARY Percentage of Participants With Normalization of Serum Uric Acid at Week 24 and Week 52 |
27.7; 12.2 | — |
| SECONDARY Change From Baseline in Number of Gout Flares |
-0.83; -1.00 | — |
| SECONDARY Number of Swollen Joints Over Time |
8.60; 4.05; 1.46 | — |
| SECONDARY Number of Tender Joints Over Time |
9.33; 2.38; 0.79 | — |
| SECONDARY Number of Palpable Tophi Over Time |
13.58; 5.70; 3.68 | — |
Summary
The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.
Eligibility Criteria
Inclusion Criteria
- Adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated.
- Patients who have made the decision, along with their treating physician, to begin treatment with KRYSTEXXA.
- Patients who are willing and able to give informed consent and adhere to visit/protocol schedules.
Exclusion Criteria
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Non-compensated congestive heart failure
- Pregnancy or breast feeding
- Prior treatment with pegloticase or another recombinant uricase
- Known allergy to urate oxidase
- Prior treatment or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug
- Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
Data sourced from ClinicalTrials.gov (NCT01466166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.