2024-519977-20-00招募中2 期
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)
Centre Hospitalier National D'Ophtalmologie Quinze-Vingts10 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年1月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 10
- 主要终点
- The primary endpoint will be the ocular improvement at W8. This improvement will be defined as the increase of at least two lines of visual acuity on the ETDRS chart.
研究概览
简要总结
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)
研究设计
- 分配方式
- Randomized
- 主要目的
- Multicenter Interventional Randomized Non-comparative Phase Ii Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
- •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, or imaging data 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
- •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.
结局指标
主要结局
The primary endpoint will be the ocular improvement at W8. This improvement will be defined as the increase of at least two lines of visual acuity on the ETDRS chart.
The primary endpoint will be the ocular improvement at W8. This improvement will be defined as the increase of at least two lines of visual acuity on the ETDRS chart.
次要结局
- Time to first recurrence of GCA
- Stabilization of vision, as judged at W8 after treatment start, correspond to a lack of improvement (cf primary objective), and a lack of deterioration.
- Occurrence of a visual improvement defined as an increase of two lines or more of visual acuity on ETDRS chart, a clinically significant difference, at W4 and W13
- Change in Mean Deviation (MD) measured on an automatized Visual Field (SITA Standard Humphrey 24-2) at weeks 4, 8, and 13.
- Changes in angio-OCT between baseline and W4: superficial and deep vascular plexus will be examined to look for the decrease of ischemia in peripapillary and macular areas.
- Proportion of patients with improvement of other manifestations of GCA with tocilizumab and prednisone at weeks 4, 8, and 13.
- Proportion of patients with biological improvement (i.e. CRP and ESR) with tocilizumab and prednisone at weeks 4, 8, and 13.
- Influence of 1-month tocilizumab treatment on recurrence of AION, at W13.
- Influence of 1-month tocilizumab treatment on recurrence of GCA, at W13.
- Safety as assessed by adverse events, and serious adverse events.
- Immunological biomarkers of response to Tocilizumab assessed at W0, W4, and W13.
研究者
Project Manager
Scientific
Centre Hospitalier National D'Ophtalmologie Quinze-Vingts
研究点 (10)
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