Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA

• Status: Not yet recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Collaborator: Roche Chugai
• Treatments: Aspirin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• Age of 50 years or older

• Social insurance

• Diagnosis of AION, characterized by sudden and painless loss of vision, of less than one week, accompanied by pallid swelling of the optic disc

• Diagnosis of GCA based on ACR 1990 criteria, i.e. 3 of 5 criteria among : 1) age ≥ 50 years, 2) new headache, 3) abnormal temporal artery, 4) erythrocyte sedimentation rate ≥ 50 at 1 hour or C reactive protein ≥ 20, 5) artery biopsy showing vasculitis

Exclusion Criteria:

• Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION

• Biological targeting therapy within 3 months preceding the study

• Evidence of active infection

• History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years

• History of recurrent infections, diverticulitis or intestinal ulceration and ASAT/ALAT > 5 * upper limit of normal, according to the Summary of Product Characteristics of tocilizumab

• Contraindication to steroids and/or aspirin administrated in the treatment

• Breastfeeding women and women with childbearing potential without highly effective contraception.

• Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at the inclusion

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and for 3 months after the last administration of tocilizumab.

• Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), absolute lymphocyte count < 0.5 × 109/L (500/mm3)

• Insufficient liver function (Child Pugh C )

• Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less

• Patients with previously untreated tuberculosis, previously known TDM/radiographic evidence suggestive of active and/or sequellar tuberculosis

• HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion

• Contraindication to and precaution in use of tocilizumab according to the summary product description

• Inability to provide informed consent