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

Plain Language Summary

Simplified for easier understanding

This study is for people with chronic gout who are already taking or who have been prescribed a medicine called febuxostat to lower uric acid levels. The study is not testing a new drug — instead, it is looking at how different patients respond to different doses of febuxostat, to help doctors prescribe the right amount for each person. You may be eligible if: - You are 18 years of age or older - Febuxostat has been prescribed or recommended for your chronic gout You may NOT be eligible if: - You have had an allergic reaction to febuxostat in the past - You take mercaptopurine, azathioprine, or theophylline (medications that interact with febuxostat) - You are a woman who is pregnant, breastfeeding, or of childbearing age and not willing to avoid pregnancy during the study - You have a psychological condition that would prevent you from understanding the study requirements Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.