Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Tocilizumab will be proposed to eligible patients as an emergency treatment, in addition to the standard high-dose steroid treatment. Each patient will receive the reference treatment, i.e. one pulse of high dose intravenous methylprednisolone per day during 3 days, followed by 1 mg/kg/day oral prednisone, and low dose aspirin. Depending on the randomization, each patient will receive the reference treatment only, or will received in addition to the reference treatment four subcutaneous injections of tocilizumab 162 mg over one month (1 injection per week), the first tocilizumab injection being delivered on the same day than the first steroid IV pulse. Study visits will take place at 4, 8 and 13 weeks. The primary endpoint will be the ocular improvement at W8, defined as an increase of at least two lines of visual acuity on the ETRS chart. For each patient, the duration of participation will by of 3 months. The study duration is expected to be 15 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04239196
Study type Interventional
Source Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Contact Tania RILCY
Phone +33 140021126
Email trilcy@15-20.fr
Status Recruiting
Phase Phase 2
Start date September 10, 2020
Completion date December 10, 2022

See also
  Status Clinical Trial Phase
Completed NCT03812302 - Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA) Phase 2
Recruiting NCT02257866 - Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Recruiting NCT04888221 - Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement Phase 3
Recruiting NCT05380453 - Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission Phase 3
Recruiting NCT02333708 - Study of Circulating Microparticles in Giant Cell Arteritis
Completed NCT01450137 - Tocilizumab for Patients With Giant Cell Arteritis Phase 2
Completed NCT03827018 - KPL-301 for Subjects With Giant Cell Arteritis Phase 2
Active, not recruiting NCT04519580 - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Completed NCT03202368 - An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA) Phase 3
Not yet recruiting NCT06004154 - Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)
Not yet recruiting NCT02523625 - Giant Cell Arteritis: Improving Use of Ultrasound Evaluation N/A
Completed NCT03285945 - FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment N/A
Completed NCT02190916 - Vasculitis Illness Perception (VIP) Study N/A
Recruiting NCT01241305 - One-Time DNA Study for Vasculitis
Terminated NCT02531633 - Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis Phase 3
Completed NCT03409913 - Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA N/A
Completed NCT03765424 - Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
Completed NCT01910038 - Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. Phase 2
Not yet recruiting NCT04012905 - Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering Phase 3
Completed NCT03726749 - Tocilizumab Plus a Short Prednisone Taper for GCA Phase 4