drugset / Trial / NCT04239196
Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA
Phase 2
Unknown
58 enrolled
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Roche Chugai · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
AION is the main cause of blindness in patients with GCA. High dose steroid is the reference treatment of this condition, but medical unmet need remains. Subcutaneous tocilizumab, a targeted biotherapy, recently received marketing authorization for the treatment of GCA, but only demonstrated at yet that it can allow steroid dose sparing. The aim of this study is to assess the benefit of tocilizumab and IV steroids combination or IV steroids alone, in the treatment of AION due to GCA.
Timeline
- Start
- 2020-09-10
- Primary completion
- 2020-11-09
- Completion
- 2022-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 162 mg | Subcutaneous |
| Background | Aspirin | Small molecule | 75 mg | — |
| Background | Methylprednisolone | Other / unclassified | 7.5 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 15 mg/kg | Intravenous |
| Background | Prednisone | Other / unclassified | 1 mg/kg | Oral |