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).
Author
Hazell, MaeReeves, Barnaby
Rogers, Chris A
Pike, Katie
Culliford, Lucy
Baos, Sarah
Lui, Mandy P Y
Beare, Nicholas A V
Pavesio, Carlos
Denniston, Alastair K
Wordsworth, Sarah
Keane, Pearse A
Wilson, Robert
Folkard, Annie
Peto, Tunde
Sharma, Srilakshmi M
Dick, Andrew
Publication date
2024-01-24Subject
Ophthalmology
Metadata
Show full item recordAbstract
Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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.Citation
Hazell M, Reeves B, Rogers CA, Pike K, Culliford L, Baos S, Lui MPY, Beare NAV, Pavesio C, Denniston AK, Wordsworth S, Keane PA, Wilson R, Folkard A, Peto T, Sharma SM, Dick A. 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. 2024 Jan 24;14(1):e082246. doi: 10.1136/bmjopen-2023-082246.Type
ArticlePMID
38267244Journal
BMJ OpenPublisher
BMJ Publishing Groupae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2023-082246