Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (NCT01124838) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
261 participantsStarted 2010-08
Plain-language summary
A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Subject is diagnosed with non-infectious intermediate, posterior, or panuveitis.
* 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 ≤ 0.5+ according to Standardization of Uveitis Nomenclature (SUN) criteria.
* Subject with vitreous haze grade ≤ 0.5+ according to National Eye Institute (NEI)/SUN criteria.
* Subject is on oral prednisone 10 to 35 mg/day (or oral 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 documented history of experiencing at least one disease flare within 18 months of the Screening visit. This flare has to occur during or up to a maximum of 28 days after tapering off the oral corticosteroid therapy.
* Subjects who do not have previous, active or latent tuberculosis (TB). Only one TB test is required to allow the subject in the study. Subjects with either negative purified protein derivative (PPD) (\< 5 mm of induration) or negative QuantiFERON®-TB Gold test (or interferon-gamma release assay (IGRA) equivalent) are eligible. Subjects with a re…
What they're measuring
1
Time to Treatment Failure on or After Week 2
Timeframe: From Baseline until end of study (up to 80 weeks)