Hazell, Mae, Reeves, Barnaby, Rogers, Chris A, Pike, Katie, Culliford, Lucy, Baos, Sarah, Lui, Mandy PY, Beare, Nicholas AV 
ORCID: 0000-0001-8086-990X, Pavesio, Carlos, Denniston, Alastair K et al (show 7 more authors)
(2024)
Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness-a protocol for a randomised controlled trial (ASTUTE trial).
BMJ open, 14 (1).
e082246-e082246.
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Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis Tolerability, Effectiveness and cost-effectivenes.pdf - Open Access published version Download (1MB) | Preview |
Abstract
<h4>Introduction</h4>Adalimumab is an effective treatment for autoimmune non-infectious uveitis (ANIU), but it is currently only funded for a minority of patients with ANIU in the UK as it is restricted by the National Institute for Health and Care Excellence guidance. Ophthalmologists believe that adalimumab may be effective in a wider range of patients. The Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness (ASTUTE) trial will recruit patients with ANIU who do and do not meet funding criteria and will evaluate the effectiveness and cost-effectiveness of adalimumab versus placebo as an add-on therapy to standard care.<h4>Methods and analysis</h4>The ASTUTE trial is a multicentre, parallel-group, placebo-controlled, pragmatic randomised controlled trial with a 16-week treatment run-in (TRI). At the end of the TRI, only responders will be randomised (1:1) to 40 mg adalimumab or placebo (both are the study investigational medicinal product) self-administered fortnightly by subcutaneous injection. The target sample size is 174 randomised participants. The primary outcome is time to treatment failure (TF), a composite of signs indicative of active ANIU. Secondary outcomes include individual TF components, retinal morphology, adverse events, health-related quality of life, patient-reported side effects and visual function, best-corrected visual acuity, employment status and resource use. In the event of TF, open-label drug treatment will be restarted as per TRI for 16 weeks, and if a participant responds again, allocation will be switched without unmasking and treatment with investigational medicinal product restarted.<h4>Ethics and dissemination</h4>The trial received Research Ethics Committee (REC) approval from South Central - Oxford B REC in June 2020. The findings will be presented at international meetings, by peer-reviewed publications and through patient organisations and newsletters to patients, where available.<h4>Trial registration</h4>ISRCTN31474800. Registered 14 April 2020.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Uveitis, Quality of Life, Cost-Benefit Analysis, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Standard of Care, Adalimumab |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 05 Feb 2024 10:36 |
| Last Modified: | 05 Feb 2024 10:41 |
| DOI: | 10.1136/bmjopen-2023-082246 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3178388 |
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