Clinical trial: Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA (NCT04239196)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? Contradiction