A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non infectious Intermediate-, Posterior-, or Pan-uveitis - ND

• Conditions: Active Non-infectious Intermediate-, Posterior-, or Pan-uveitis.; MedDRA version: 9.1Level: LLTClassification code 10022557; MedDRA version: 9.1Level: LLTClassification code 10033687; MedDRA version: 9.1Level: LLTClassification code 10036370

• Registration Number: EUCTR2009-016095-68-IT
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Subject is = 18 years of age. • Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis. • Subject must have active disease at Baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of prednisone = 10 mg/day (or oral corticosteroid equivalent): o Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion o = 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria) o = 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria) • Subject is on prednisone = 10 mg/day (or corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from Screening to Baseline visit. • Subject with prior adequate response to corticosteroids (equivalent of prednisone up to 1 mg/kg/day).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subject with isolated anterior uveitis. • Subject with prior inadequate response to or intolerance to high-dose corticosteroids (equivalent of prednisone 1 mg/kg/day or 60 to 80 mg/day). • Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, (cytomegalovirus), Lyme disease, toxoplasmosis and HSV (herpes simplex virus). • Subject with serpiginous choroidopathy. • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial. • Subject with intraocular pressure of = 25 mmHg and on = 2 glaucoma medications or evidence of glaucomatous optic nerve injury. • Subject with best corrected visual acuity (BCVA) worse than 20/200 (ETDRS logMAR > 1.0) in at least one eye. • Subject with intermediate uveitis and symptoms and/or MRI findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis must have had a prior brain MRI at time of or after diagnosis of intermediate uveitis. • Subject has previous exposure to anti-TNF therapy and any biologic therapy (including anti-VEGF therapy)with a potential therapeutic impact on non-infectious uveitis. • Subject has received glucocorticosteroids implant (Retisert). • Subject has received intraocular or periocular corticosteroids within 90 days prior to Baseline visit. • Subject with proliferative or severe non-proliferative diabetic retinopathy. • Subject with neovascular/wet age-related macular degeneration • Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process. • Subject with severe vitreous haze that precludes visualization of the fundus at the Baseline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects requiring high dose corticosteroids for active non-infectious intermediate-, posterior-, or pan-uveitis.;Secondary Objective: N.A.;Primary end point(s): Time to treatment failure. Please refer to section 5.3.3.1 of the study protocol for further information.