Efficacy and Safety of Adalimumab in Patients With Active Uveitis (NCT01138657) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Adalimumab in Patients With Active Uveitis
239 participantsStarted 2010-08
Plain-language summary
A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is at least 18 years of age.
* Subject is diagnosed with non-infectious intermediate-, posterior-, or panuveitis.
* Subject must have active disease at the Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent):
* Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
* ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria)
* ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria)
* Subject is on oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from Screening to Baseline visit.
* Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
* 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 repeat indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent) result are not eligible. Note, that only one TB screening test is allowed and required. A rep…
What they're measuring
1
Time to Treatment Failure on or After Week 6
Timeframe: From Baseline until end of study (up to 80 weeks)