RecruitingPhase 4ACTRN12616000959471

A multicentre study of the dose concentration response of febuxostat in patients with chronic gout.

A multicentre, prospective, open-label, pharmacokinetic pharmacodynamic (PKPD) study of febuxostat in patients with chronic gout.

Sponsor

St Vincent's Hospital

Enrollment

120 participants

Start Date

Sep 13, 2016

Study Type

Interventional

Conditions

Gout

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Patients for whom febuxostat is, or has been, clinically indicated for the treatment of chronic gout.

Exclusion Criteria4

Any patient with a past history of febuxostat hypersensitivity.
Patients taking xanthine oxidoreductase substrates such as mercaptopurine/azathioprine or theophylline (no studies to substantiate the combination with febuxostat).*
Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
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.

Interested in this trial?

Get notified about updates and connect with the research team.

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, 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.