None listed
Conditions
Brief summary
The objectives of the study are: 1) Explore the dose-concentration-response relationship of febuxostat in patients with chronic gout. 2) Gain insights into optimisation of febuxostat therapy to achieve target plasma urate concentrations. 3) Understand inter-patient variations in the pharmacokinetic parameters of the drug and their impact on the serum urate concentration. 4) Explore factors that may affect the pharmacokinetics and/or the response of urate to febuxostat.
Interventions
This study aims at exploring a) the dose-concentrations-response relationships of febuxostat in patients with chronic gout b) the influence of renal function on the plasma concentrations of febuxostat and response of urate to febuxostat.
A number of blood samples (up to 4 blood samples per dose level) will be collected at least one week after the initiation and/or dose adjustment for the determination of the plasma concentrations of febuxostat and urate. In this open-label observational study,
This study aims at exploring a) the dose-concentrations-response relationships of febuxostat in patients with chronic gout b) the influence of renal function on the plasma concentrations of febuxostat and response of urate to febuxostat. A number of blood samples (up to 4 blood samples per dose level) will be collected at least one week after the initiation and/or dose adjustment for the determination of the plasma concentrations of febuxostat and urate. In this open-label observational study, the dose of febuxostat, dose adjustment, duration of administration and the target treatment serum urate are judged by the treating rheumatologist as part of usual management of gout. Some data will be collected including; baseline and steady-state treatment concentrations of serum urate and creatinine, age, sex, height, weight, medical history and current co-morbidities and concomitant therapies (including change in co-therapies during enrollment). Some information pertaining to gout (duration of gout, frequency of gout attacks and past gout treatments, if any) will also be collected. Patients will be asked to complete The ARMS (Adherence to Refills and Medications Scale) questionnaire in order to assess their general adherence behaviour. A ‘Febuxostat adherence Questionnaire’ will also be completed before each blood collection in order to capture the extent of adherence to treatment with febuxostat over the week prior to collecting a blood sample. Patients will also be offered a participant's diary to monitor their adherence to febuxostat. Patients will be followed up for up to 6 months from recruitment. After the follow up period ends, patients with chronic gout will continue to take febuxostat to maintain their serum urate concentrations below the target concentrations, as part of their chronic gout management, treating doctors will continue following up patients as per usual care.
Sponsors
St Vincent's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients for whom febuxostat is, or has been, clinically indicated for the treatment of chronic gout.
Exclusion criteria
1) Any patient with a past history of febuxostat hypersensitivity. 2) Patients taking xanthine oxidoreductase substrates such as mercaptopurine/azathioprine or theophylline (no studies to substantiate the combination with febuxostat).* 3) Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. 4) Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
Outcome results
None listed