drugset / Trial / NCT03828019

Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

NCT03828019

Phase 3 Completed 227 enrolled JHSPH Center for Clinical Trials
RandomizedParallel-groupOpen-labelTreatment

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)-α 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.

Timeline

Start
2019-09-16
Primary completion
2024-04-02
Completion
2024-09-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 20 mg Subcutaneous
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Azathioprine Small molecule 2 mg/kg
Comparator Cyclosporine Peptide 2 mg/kg
Comparator Cyclosporine Peptide 2.5 mg/kg
Comparator Methotrexate Small molecule 15 mg
Comparator Mycophenolate Mofetil Small molecule 1 g
Comparator Tacrolimus Small molecule 1 mg

Indications