Extension of placebo-controlled study of AIN457 in quiescent uveitis
Research type
Research Study
Full title
A 38-week extension to a 24-week, multicenter, randomised, double-masked, placebo-controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis
IRAS ID
55476
Contact name
Christopher Brittain
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2009-015508-24
ISRCTN Number
Not available
Research summary
Non-infectious uveitis (inflammation of the eye) is characterised by recurrent flare-ups of inflammation in one or both eyes, which can lead to damage to the eye resulting in loss of vision or blindness. Corticosteroids are commonly used in the treatment of uveitis, but these treatments are not effective in all cases, and can have side effects, particularly if used at high doses over long periods of time.
Interleukin-17A (IL-17A) is a cytokine which is believed to be partly responsible for causing inflammation in the body, and levels have been found to be raised in the blood of some patients with uveitis. AIN457 is a human monoclonal antibody, which binds to IL-17A and thereby reduces its activity.
The purpose of this extension study is to provide patients with non-active, non-infectious uveitis who have completed the 24-week core study (CAIN457C2301) with an opportunity to receive an additional 26 weeks of continuous treatment, providing further data on the effectiveness and safety of AIN457, and to see if their disease can be controlled when their usual medication is gradually withdrawn.
Eligible patients who have provided written agreement to take part in this extension study will continue to receive the same treatment as they received in the core study (one of three different doses of AIN457 or placebo) in addition to their usual prescribed treatment for uveitis.
Patients will visit the hospital clinic 16 times in total over the 26-week period, and the main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography, measurement of intraocular pressure, physical examinations, blood pressure, pulse, temperature, breathing rate, blood tests and completion of health-related questionnaires.
Around 209 patients will enter this study having completed the core study, of which 30 will be from the UK.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
10/H0605/33
Date of REC Opinion
14 Jun 2010
REC opinion
Favourable Opinion