Adalimumab vs. Conventional Immunosuppression for Uveitis Trial (NCT03828019) | Clinical Trial Compass
CompletedPhase 3
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
United States227 participantsStarted 2019-09-16
Plain-language summary
Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-tumor necrosis(TNF)-Ξ± monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.
Who can participate
Age range13 Years
SexALL
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Inclusion criteria
β. Age 13 years or older
β. Weight 30 kg (66 lbs) or greater
β. Active or recently active (β€ 60 days) non-infectious intermediate, posterior, or panuveitis
β. Prednisone indication meets one of the following:
β. Active uveitis requiring one of the following i. Initiation of prednisone at dose greater than 7.5 mg/day ii. Increasing prednisone dose to greater than 7.5 mg/day iii. Currently receiving dose greater than 7.5 mg/day
β. Inactive uveitis on current dose greater 7.5 mg/day
β. Initiation or addition of an immunosuppressive drug (i.e., a conventional immunosuppressive drug or adalimumab) is indicated
β. If currently receiving a conventional immunosuppressive drug, the drug and dose have been stable for at least 30 days
Exclusion criteria
β. Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-Ξ³ release assay \[Interferon-gamma release assay (IGRA) test, such as Quantiferon-gold)
What they're measuring
1
Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization