drugset / Trial / NCT03828019
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |