The ASTUTE Trial
Research type
Research Study
Full title
Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness: a randomized controlled trial.
IRAS ID
271051
Contact name
Andrew Dick
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Eudract number
2020-000754-97
ISRCTN Number
ISRCTN31474800
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Autoimmune uveitis is a term for several rare eye diseases in which the body’s own immune system causes sight-threatening damage to the light sensitive retina at the back of the eye. Uveitis causes sight loss from inflammation inside the eye, damage to blood vessels in the retina or leakage of fluid into the central, most sensitive area of the retina. Two in 10,000 people are at risk of serious sight loss from uveitis. Usual treatment involves low dose steroids and other drugs to reduce inflammation. Many patients do not respond to or tolerate usual treatment, or they need high dose steroids. Long term high dose steroids carry a risk of serious side effects.
Recent studies suggest a drug called adalimumab, which neutralises a chemical in the body called TNF-alpha, is an effective way to treat uveitis in some patients. However, drugs like adalimumab can have serious side effects and more evidence is required to identify which patients with uveitis benefit the most from adalimumab.
The ASTUTE Trial aims to identify patients who are most likely to benefit from adalimumab. Participants will be given adalimumab for a 16-week trial period in combination with their usual uveitis medications. Over the 16 weeks, doctors will aim to reduce steroids to a low dose that should not cause side effects.
Patients who respond well to adalimumab and are on low dose steroids will enter the main randomised, double-masked placebo-controlled trial for 12-30 months. Regular eye examinations, imaging and questionnaires will be used to assess how well patients are doing. The aim is to find out whether adalimumab is better at preventing recurrence of uveitis than placebo and whether adalimumab is cost-effective compared to placebo treatment.
Patients will be recruited from UK NHS hospitals; 400 to the 16-week trial period, of which 174 will progress into the randomised trial.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0153
Date of REC Opinion
3 Jun 2020
REC opinion
Further Information Favourable Opinion