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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Athimalaipet V.
Ramanan
avramanan@hotmail.com
Dr
Athimalaipet V.
Ramanan
avramanan@hotmail.com
Disorders of sclera, cornea, iris and ciliary bodyInflammatory polyarthropathies
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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 or ANA-positive chronic anterior uveitis (CAU) 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 and CAU. This study could also identify predictors of disease flare and drug response that would be useful in making evidence-based treatment decisions.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
Intraocular surgery in the past 90 days or planned surgery in the next 180 days Severe cataract or opacity preventing view to the posterior pole in both eyes Acute or recurrent anterior uveitis characterized by redness and symptoms, including but not limited to: floaters, light sensitivity, pain Chronic hypotony (< 5 mmHg for > = 90 days) in either eye Treatment with oral corticosteroids or intraocular corticosteroid injections within the last 12 months Acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age) Prior safety or tolerability issues with adalimumab History of cancer, tuberculosis, or hepatitis B Other medical condition expected to dictate treatment course during the study Any of the following abnormal lab values within 28 days prior to enrollment: leukocyte count < 2500, platelet count < = 75000, hemoglobin< 9.0, AST (SGOT) or ALT (SGPT) > = 2 times the upper limit of normal range, creatinine > = 1.5
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of California, San Francisco (USA) and funded by National Institutes of Health (NIH), United States .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 42057
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