Sign in
CompletedPhase 2

Efficacy of tocilizumab in the treatment of acute anterior ischemic optic neuropathy optic neuropathy in Horton's disease

Key facts

Who runs it
Centre Hospitalier National D'Ophtalmologie Quinze-Vingts
Where
France10 sites in 1 countryChoose a country to see its sites
Status
Completed
Phase
Phase 2
People taking part
58 people enrolled
Started
27 Jan 2025
Ended
24 Sept 2025
Type of study
Interventional
Record updated
27 January 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Diagnosis of GCA (Giant Cell Arteritis)
  • AION characterized by sudden and painless loss of vision, accompanied by pallid swelling of the optic disc, of no more than one-week duration
  • Age of 50 years or older
  • Social insurance

Who cannot take part

  • Patients with previously untreated tuberculosis, or imaging data suggestive of active and/or sequellar tuberculosis
  • Biological targeting therapy within 3 months preceding the study
  • 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
  • Contraindication to steroids and/or aspirin administrated in the treatment
  • Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
  • HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion
  • Evidence of active infection
  • 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
  • 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 kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
  • Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at the inclusion
  • Insufficient liver function (Child Pugh C )
  • Contraindication to and precaution in use of tocilizumab according to the summary product description
  • Inability to provide informed consent
  • Breastfeeding women and women with childbearing potential without highly effective contraception
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To determine if induction therapy by 4 subcutaneous tocilizumab injections over one month (every 7 days) in association to conventional steroid regimen could improve ocular outcome in acute anterior ischemic optic neuropathy (AION) related to Giant Cell Arteritis (GCA)

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
French prospective open label phase II randomized non-comparative study of SC tocilizumab associated with IV pulse steroid versus IV pulse steroid alone for the treatment of acute anterior ischemic optic neuropathy associated with giant cell arteritis. (TOCIAION)
Record updated
27 January 2025