Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 2
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Voir sur ClinicalTrials)
septembre 2020
décembre 2022
24 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Catherine VIGNAL-CLERMONT | 21/06/2024 13:33:11 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Benjamin terrier, MD, PHD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Arsene Mekinian, MD | Contact (sur clinicalTrials) | |||
| CHNO DES QUINZE-VINGTS PARIS | Emmanuel Heron, MD | Contact (sur clinicalTrials) | |||
| HDJ MONTFERMEIL | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Caen - Hôpital de la Côte de Nacre - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital François Mitterrand - 21000 - Dijon - France | Maxime Samson | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Groupe Hospitalier Diaconesses-Croix Saint Simon, - 75020 - Paris - France | Contact (sur clinicalTrials) | ||||
| Pitié-Salpetrière Hospital - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Age of 50 years or older
2. Social insurance
3. Diagnosis of AION, characterized by sudden and painless loss of vision, of less than
one week, accompanied by pallid swelling of the optic disc
4. Sudden permanent visual loss due to AION, of less than one week
5. Diagnosis of GCA based on the 1st (age ≥ 50 years) and the 3rd (Diagnosis of AION)
criteria and at least one among the following :
- One unequivocal symptom among: New onset localized headache, scalp or temporal
artery tenderness, otherwise unexplained mouth or jaw pain under mastication,
or unequivocal symptoms of polymyalgia rheumatic (shoulder and/or hip girdle
pain associated with inflammatory stiffness).
- Elevated erythrocyte sedimentation rate (≥ 50 at 1 hour) or C-reactive protein
(≥ 10 mg/l), otherwise unexplained
- Abnormal artery biopsy Biopsy specimen with artery showing vasculitis
characterized by a predominance of mononuclear cell infiltration or
granulomatous inflammation, usually with multinucleated giant cells.
- Evidence of large or medium-size vessel vasculitis at ultrasound, magnetic
resonance angiography, computed tomography angiography, or positron emission
tomography-computed tomography.
1. Age of 50 years or older
2. Social insurance
3. Diagnosis of AION, characterized by sudden and painless loss of vision, of less than
one week, accompanied by pallid swelling of the optic disc
4. Sudden permanent visual loss due to AION, of less than one week
5. Diagnosis of GCA based on the 1st (age ≥ 50 years) and the 3rd (Diagnosis of AION)
criteria and at least one among the following :
- One unequivocal symptom among: New onset localized headache, scalp or temporal
artery tenderness, otherwise unexplained mouth or jaw pain under mastication,
or unequivocal symptoms of polymyalgia rheumatic (shoulder and/or hip girdle
pain associated with inflammatory stiffness).
- Elevated erythrocyte sedimentation rate (≥ 50 at 1 hour) or C-reactive protein
(≥ 10 mg/l), otherwise unexplained
- Abnormal artery biopsy Biopsy specimen with artery showing vasculitis
characterized by a predominance of mononuclear cell infiltration or
granulomatous inflammation, usually with multinucleated giant cells.
- Evidence of large or medium-size vessel vasculitis at ultrasound, magnetic
resonance angiography, computed tomography angiography, or positron emission
tomography-computed tomography.
- 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