TNF alpha Inhibitors have been very effective in treating rheumatologic diseases as well as uveitis. Adalimumab is the first member of a new class of TNF antibody compounds developed to contain exclusively human sequences. We want to test the efficacy and safety of the TNF alpha Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive therapy.
TNF alpha Inhibitors like Infliximab and Etanercept have been very effective in treating rheumatologic diseases. They have been used to treat severe uveitis by several groups, Suhler and coworkers have published the largest series in 2005. Adalimumab, a recombinant, full-length immunoglobulin, is the first member of a new class of TNF antibody compounds developed to contain exclusively human sequences. The duration of therapeutic efficacy of other TNF antibodies, which contain non-human sequences, may be limited to a greater extent by antibody responses raised in subjects over time. We want to test the efficacy and safety of the TNF alpha Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive therapy requiring systemic corticosteroids \> 7,5mg prednisolone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Interdisciplinary Uveitis Center, University of Heidelberg
Heidelberg, Germany
Improvement of visual acuity (3 lines EDTRS)
Time frame: at week 0, 2, 6, 12 and 24
Improvement of intraocular inflammatory activity
Time frame: at week 0, 2, 6, 12 and 24
Evolution of cystoid macula edema(FLA, OCT)
Time frame: at week 0, 6, 12 and 24
Number of switchers from Arm A to Arm B
Time frame: after six months
Cumulative steroid dosage
Time frame: after six months
Frequency of adverse events
Time frame: whole study period
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