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Health Condition(s) or Problem
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Uveitis
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Lay Summary
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A study comparing the safety and efficacy of Adalimumab vs. Placebo in subjects with active
uveitis.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Subject is at least 18 years of age.
- Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
- 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 /= 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 /= 25 mmHg and on >/= 2 glaucoma medications or
evidence of glaucomatous optic nerve injury.
- Subject with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early
Treatment Diabetic Retinopathy Study) in at least one eye at the Baseline Visit.
- Subject with intermediate uveitis or panuveitis that has signs of intermediate
uveitis (e.g.presence or history of snow banking or snowballs) and symptoms and/or
Magnetic Resonance Imaging (MRI) findings suggestive of a demyelinating disease such
as multiple sclerosis. All subjects with intermediate uveitis or panuveitis that
have signs of intermediate uveitis (e.g., presence or history of snow banking or
snowballs) must have had a brain MRI within 90 days
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Who cannot enter the trial
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Inclusion Criteria:
- Subject is at least 18 years of age.
- Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
- 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 /= 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 /= 25 mmHg and on >/= 2 glaucoma medications or
evidence of glaucomatous optic nerve injury.
- Subject with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early
Treatment Diabetic Retinopathy Study) in at least one eye at the Baseline Visit.
- Subject with intermediate uveitis or panuveitis that has signs of intermediate
uveitis (e.g.presence or history of snow banking or snowballs) and symptoms and/or
Magnetic Resonance Imaging (MRI) findings suggestive of a demyelinating disease such
as multiple sclerosis. All subjects with intermediate uveitis or panuveitis that
have signs of intermediate uveitis (e.g., presence or history of snow banking or
snowballs) must have had a brain MRI within 90 days
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What will happen
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Drug; adalimumab; Subjects will be randomized into one of two arms. Arm 1 will receive adalimumab 80 mg subcutaneous (SC) loading dose at Baseline visit followed by 40 mg doses every other week starting at Week 1. Arm 2 will receive matching placebo. Randomization will be a 1:1 ratio double masked fashion to the treatment groups using baseline immunosuppressant usage as the stratification factor.; adalimumab; ABT-D2E7 Humira; Drug; prednisone; All subjects will receive a mandatory prednisone burst and taper schedule. All patients continuing in the study will be off prednisone no later than Week 15.; adalimumab; Drug; adalimumab placebo; 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.; adalimumab placebo; Drug; prednisone; All subjects will receive a mandatory prednisone burst and taper schedule. All patients continuing in the study will be off prednisone no later than Week 15.; adalimumab placebo
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Primary aim
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Time to Treatment Failure
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Secondary Aim
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Change in Anterior Chamber (AC) cell grade in each eye.; Week 6 to Final Visit/Early Termination Visit; No; Final Visit could occur at any point up to 80 weeks; Change in Vitreous Haze grade in each eye (National Eye Institute/ Standardization of Uveitis Nomenclature [NEI/SUN] criteria in each eye.; Week 6 to Final Visit/Early Termination Visit; No; Final Visit could occur at any point up to 80 weeks; Change in logarithm of the minimum angle of resolution (logMAR) BCVA in each eye; Week 6 to Final Visit/Early Termination Visit; No; Final Visit could occur at any point up to 80 weeks; Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least one eye; Evaluated at all visits at or after the Week 6 Visit; No; Change in central retinal thickness in each eye; Week 6 to Final Visit/Early Terminationation; No; Final Visit could occur at any point up to 80 weeks; Change in NEI Visual Functioning Questionnaire (VFQ-25) score; Week 6 to Final Visit/Early Termination Visit; No; Final Visit could occur at any point up to 80 weeks
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://rxabbvie.com
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Recruitment Status
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Recruiting
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Nation
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Scotland, England
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Location
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Aberdeen, Bristol, Liverpool, London
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