ADJUST
Research type
Research Study
Full title
Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)
IRAS ID
259372
Contact name
A Ramanan
Contact email
Eudract number
2019-000412-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
We propose a multicenter, double-masked, randomized controlled trial comparing the treatment strategies of discontinuing versus continuing adalimumab in patients with a ≥12 month-history of controlled Juvenile Idiopathic Arthritis (JIA)-associated uveitis on adalimumab. One hundred eighteen patients (fifty-nine per arm) will be enrolled at nine US centers, six UK centers, and one Australia center for this trial. Patients will be randomized to continue their current dose of adalimumab or stop adalimumab and inject placebo, stratifying by study center and concomitant methotrexate or mycophenolate mofetil use. Patients will be followed by an ophthalmologist and rheumatologist for a total of 12 months, with the primary outcome assessed at 6 months and secondary outcomes assessed over 6 and 12 months. We will compare time to recurrence of ocular inflammation between treatment arms with an endpoint of 6 months (Aim 1). We will also evaluate potential clinical and laboratory predictors of uveitis relapse (Aim 2). Patients who are randomized to discontinue adalimumab and flare will be able to restart adalimumab treatment. We will assess 12-month outcomes of the treatment strategies in Aim One by comparing the proportion of patients with corticosteroid-sparing control of ocular inflammation at 12 months in each arm (Aim 3). With the increasing use of TNF-α inhibitors, understanding the risks and benefits of stopping treatment is important to inform clinical practice for management of JIA-associated uveitis. This study could also identify predictors of disease flare and drug response that would be useful in making evidence-based treatment decisions.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0112
Date of REC Opinion
15 May 2019
REC opinion
Further Information Favourable Opinion