We are looking for two independent statisticians for the DMC and TSC of a phase II feasibility trial. The trial title is:
"Interleukin-1 receptor antagonist treatment for persistent complex regional pain syndrome."
Please see below for further summary information.
The trial is currently in setup with the aim of starting recruitment at the beginning of July 2021. Total study duration time is expected to be 24 months (with 18 months expected recruitment time).
The sample size is 30 patients for this single arm open-label study. The treatment period per patient is 120 days and the follow-up period if 180 days per patient.
The trial will be run by the Liverpool Clinical Trials Centre, and the University of Liverpool is the trial Sponsor.
The DMC and TSC will meet approximately every 12 months, or sooner if needed, throughout the study.
Trial Summary Information
The INCA trial:
Interleukin-1 (IL-1) receptor antagonist treatment for persistent complex regional pain syndrome
Complex Regional Pain Syndrome (CRPS) is a condition that causes chronic refractory and debilitating neuropathic pain in a limb affected by trauma. CRPS results in both chronic neuropathic pain and associated autonomic and inflammatory symptoms and signs. These features are disproportionate to the precipitating injury and in a small proportion of patients a history of injury cannot be recalled.
One hypothesis of how CRPS affects the limb is that of immune dysfunction. If IL-1 is a key component of the pathology of CRPS then targeting it should improve outcomes of patients with this condition. Anakinra is an IL-1 receptor antagonist that competes with IL-1 beta for its receptor. It has found use in a number of autoimmune inflammatory conditions, such as juvenile arthritis.
INCA is a phase II, single arm, multicentre, feasibility study designed to examine primarily the safety and tolerability of anakinra in patients with refractory moderate to severe Complex Regional Pain Syndrome (CRPS). Secondary objective is to identify any barriers to patient recruitment and retention and to obtain data (e.g. pain intensity measure, CRPS severity, medication use, quality of life measures) to aid potential design of a larger RCT in the future. INCA is an open label study. Patients will be identified and recruited from two specialist pain management centres in the UK. Anakinra will be a fixed dose self-administered subcutaneously once daily.
30 patients in total are due to be recruited from the two participating specialist pain management centres over a 18 month recruitment period and the total study duration is 24 months. The target population is adult patient with moderate to severe CRPS that has been refractory to conventional management and a duration of 18 months to 10 years. Duration of treatment is 120 days per patient and the duration of follow-up is 180 days per patient.
Funding has already been secured for this phase II study. Greenlight and sites openings for recruitment were impacted by the COVID-19 pandemic last year. We are now resuming activities in trial set-up and aim to start recruitment at the start of July 2021.
If you are interested in supporting the study by becoming the DMC or TSC statistician, or would like more information - please contact myself or the trial manager, Simon Winn ([log in to unmask]<mailto:[log in to unmask]>), enclosing your research CV and outlining your relevant experience of such committees, if any.
Thank you and kind regards
Elaine Howarth
Senior Statistician, Liverpool Clinical Trials Centre,
The University of Liverpool, 1st floor Clock C, Waterhouse Building, 3 Brownlow Street, Liverpool. L69 3GL
Email: [log in to unmask]<mailto:[log in to unmask]>
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