This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension
Time frame: Baseline to 52 weeks
Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value
The changes in steps (0, 1, or \>= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (\<1+ anterior chamber cell grade and \<1+ vitreous haze) for at least 2 weeks
Time frame: Baseline to 52 weeks
Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension
The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score
Time frame: Baseline to 52 weeks
Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies
Evaluation of recurrence until resolution is ascertained, based on the first criteria (a \>2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4
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Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Cambridge, Massachusetts, United States
Novartis Investigative Site
Teaneck, New Jersey, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
...and 25 more locations
Time frame: Baseline to 52 weeks
Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension
IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment \& baseline IMS as covariate, where the lower IMS showed better clinical outcome.
Time frame: Baseline to 52 weeks