Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (Visual II)

INTERVENTION: investigational material(s) Generic name etc : adalimumab INN of investigational material : adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : 80 mg subcutaneous (SC) loading dose followed by 40 mg doses every other week starting at Week 1. Generic name etc : prednisone INN of investigational material : prednisone Therapeutic category code : 245 Adrenal hormone preparations Dosage and Administration for Investigational material : Based on the dose of corticosteroids at study entry, a pre‐defined taper schedule will be followed that mandates discontinuation of corticosteroid therapy no later than Week 19. Subjects who enter this study on another corticosteroid will be converted to an equivalent dose of prednisone at Baseline. control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Placebo 80 mg subcutaneous (SC) loading dose at the Baseline study visit followed a week later by 40 mg placebo injections every other week starting at Week 1. CONDITION: Inactive Non‐infectious Intermediate‐, Posterior‐, or Pan‐uveitis PRIMARY OUTCOME: Time to Treatment Failure SECONDARY OUTCOME: Change in Anterior Chamber (AC) cell grade in each eye; Change in Vitreous Haze grade in each eye (National Eye Institute/Standardization of Uveitis Nomenclature [NEI/SUN] criteria); Change in logarithm of the minimum angle of resolution (logMAR) BCVA in each eye; Time to optical coherence tomography (OCT) evidence of macular edema in at least one eye; Change in central retinal thickness in each eye ; Change in NEI Visual Functioning Questionnaire (VFQ‐25) score INCLUSION CRITERIA: ‐ Subject is diagnosed with non‐infectious intermediate‐, posterior‐, or pan‐uveitis. ‐ Subject that for >/= 28 days prior to the Baseline visit has inactive disease and is taking >/= 10 mg of oral prednisone to maintain this inactive state and fulfillment of all 3 of the following criteria based on the Investigator's clinical judgment at the Screening and Baseline visits for both eyes: ‐‐‐ Subject without active, inflammatory chorioretinal and/or inflammatory retinal vascular lesions. ‐‐‐ Subject with Anterior Chamber Cell grade