The aim of this study is to determine the feasibility of running a phase III double-blind, double-dummy randomised controlled trial comparing Depo-Medrone 120mg intramuscular injection vs. Anakinra 100mg subcutaneous injection for 5 days for the treatment of acute gout attacks in patients with chronic kidney disease as defined by a eGFR \< 60mls/min/1.73m2 and ≥ 30mls/min/1.73m2.
Gout is a common condition that affects 1 in 40 people in the UK. It causes painful "attacks" of joint swelling, redness and tenderness, mostly affecting the foot, ankle, knee, hand and wrist. It is common in people with kidney disease, who also tend to be older people with other medical conditions such as high blood pressure, heart disease and diabetes. The investigators do not know the safest and best way to treat gout attacks in this increasing cohort of people. A lot of people are given treatment that can worsen their kidney disease, along with their other medical conditions. The investigators want to compare the safest treatment currently available, steroids, with a new treatment called Anakinra. This treatment stops the action of a chemical called interleukin-1 which has been discovered to play an important role in gout attacks. This treatment has already been used to treat gout attacks in a handful of patients with kidney disease. The investigators feel it may be a better alternative to steroid treatment which can sometime worsen diabetes, heart disease and blood pressure. Participants will predominantly be followed-up for one week and a final 8 week follow-up, and be recruited from hospitals in the East of England. A definitive scientific study comparing these two treatments would involve a big expensive study requiring large numbers of patients and large amounts of information to be collected. Before the investigators do a big study like this, the investigators want to perform a small study using a smaller number of patients (32 patients) over a period of 22 months in total. It will then give us information to plan a larger study to answer the question of which treatment may be better, safer and provides the most value for money for the NHS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Anakinra 100mg injection S/C Day 1 to Day 5 and Placebo Depo-Medrone (Lipofundin 3mL) I/M Day 1. Anakinra is an interleukin-1 receptor antagonist. Placebo for Depo-Medrone placebo is Lipofundin MCT/LCT 10%.
Depo-Medrone 120mg in 3mL. Placebo for Anakinra supplied from manufacturer. 120mg Depo-Medrone I/M Day 1 and Placebo Anakinra 100mg injection S/C Day 1 to Day 5.
Southend Hospital
Southend-on-Sea, Essex, United Kingdom
Resolution of pain: time to 50% reduction and complete resolution of pain in self-assessed pain intensity in the joint most affected.
VAS (0-100mm) and 5-point Likert scale.
Time frame: Baseline (Day 1) to Day 7
Participant reported outcome measure of treatment response
5-point Likert scale score
Time frame: Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Physician / Investigator assessment of joint tenderness and swelling
4-point Likert scale score
Time frame: Day 1, Day 2, Day 4 and Day 7
Participant assessment of activity limitation
Lower Extremity Functional Scale score
Time frame: Day 1, Day 2, Day 5, Day 7
Participant assessment of activity limitation and quality of life
EQ-5D-5L health states will be used to calculate the index. Health profiles will be obtained and Quality Adjusted Life Years will be derived
Time frame: Day 1, Day 2, Day 4, Day 7 and 8 weeks
Participant assessment of activity limitation and quality of life using HAQ-DI
Scores calculated from single scales and each dimension
Time frame: Day 1, Day 7 and 8
Participant assessment of quality of life
SF-36 score
Time frame: Day 1, Day 7 and 8
Healthcare resource use
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Masking
QUADRUPLE
Enrollment
21
Highly modified client service use inventory score
Time frame: 8 weeks
CRP
Changes in CRP
Time frame: Day 1, Day 4 and Day 7
White Cell Count
Changes in white cell count. Number of participants who develop neutropenia
Time frame: Day 1, Day 4 and Day 7
eGFR
Changes in eGFR
Time frame: Day 1, Day 4 and Day 7
Safety reporting
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Day 1 to 8 weeks