Inactive non-infectious intermediate-, posterior-, or pan-uveitis. MedDRA version: 12.1 Level: LLT Classification code 10022557 Term: Intermediate uveitis MedDRA version: 12.1 Level: LLT Classification code 10033687 Term: Panuveitis MedDRA version: 12.1 Level: LLT Classification code 10036370 Term: Post
Conditions
Interventions
Trade Name: Humira 40 mg solution for injection
in pre-filled syringes
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is = 18 years of age. • Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis. • Subject with inactive disease for = 90 days prior to Baseline based on the Investigators' clinical judgment and fulfillment of all 3 of the following criteria at the Screening and Baseline visits for both eyes: o Subject without active, inflammatory chorioretinal and/or inflammatory retinal vascular lesions. o Subject with Anterior Chamber Cell grade less than or equal to 0.5+ according to SUN criteria o Subject with Vitreous Haze grade less than or equal to 0.5+ according to NEI/SUN criteria • Subject is on prednisone 10 to 35 mg (or corticosteroid equivalent) at Baseline and the dose has not been increased in the past 28 days or decreased in the past 14 days. • Subject must have a history of experiencing a disease flare while tapering off their oral corticosteroid therapy within the past 18 months. 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
Exclusion criteria: • Subject with isolated anterior uveitis. • Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, CMV (cytomegalovirus), Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, HZV (herpes zoster virus), 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 the 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 the 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 clinically significant macular edema as determined by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): Time to treatment failure. Please refer to section 5.3.3.1 of the study protocol for further information.; 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 subcutaneously starting at Week 1 compared with placebo in subjects with inactive non-infectious intermediate-, posterior-, or pan-uveitis. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed