Last updated: March 3, 2022
Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Overall Status: Active - Recruiting
Phase
2
Condition
Connective Tissue Diseases
Circulation Disorders
Polymyalgia Rheumatica (Pmr)
Treatment
N/AClinical Study ID
NCT04239196
P17-03
2019-001145-40
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age of 50 years or older
- Social insurance
- Diagnosis of AION, characterized by sudden and painless loss of vision, of less thanone week, accompanied by pallid swelling of the optic disc
- Sudden permanent visual loss due to AION, of less than one week
- 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 temporalartery tenderness, otherwise unexplained mouth or jaw pain under mastication, orunequivocal symptoms of polymyalgia rheumatic (shoulder and/or hip girdle painassociated 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 vasculitischaracterized by a predominance of mononuclear cell infiltration or granulomatousinflammation, usually with multinucleated giant cells.
- Evidence of large or medium-size vessel vasculitis at ultrasound, magneticresonance angiography, computed tomography angiography, or positron emissiontomography-computed tomography.
Exclusion
Exclusion Criteria:
- Other ocular involvements related to GCA (central retinal artery occlusion, posteriorischemic optic neuropathy, transient ocular manifestations, occipital stroke), if notassociated 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 cellcarcinoma of the skin or solid tumors treated with curative therapy and disease-freefor 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 oftocilizumab
- Contraindication to steroids and/or aspirin administrated in the treatment
- Breastfeeding women and women with childbearing potential without highly effectivecontraception.
- Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test atthe inclusion
- Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring 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 < 85g/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 orcreatinine clearance of 20 ml/min or less
- Patients with previously untreated tuberculosis, previously known TDM/radiographicevidence suggestive of active and/or sequellar tuberculosis
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if knownbefore study inclusion
- Contraindication to and precaution in use of tocilizumab according to the summaryproduct description
- Inability to provide informed consent
Study Design
Total Participants: 58
Study Start date:
September 10, 2020
Estimated Completion Date:
December 10, 2022
Study Description
Connect with a study center
CHU de Caen - Hôpital de la Côte de Nacre
Caen, 14033
FranceSite Not Available
Hôpital François Mitterrand
Dijon, 21000
FranceActive - Recruiting
CHU de Limoges
Limoges, 87042
FranceSite Not Available
CH Montfermeil
Montfermeil, 93370
FranceSite Not Available
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
FranceActive - Recruiting
Cochin Hospital
Paris, 75014
FranceActive - Recruiting
Fondation Rothschild,
Paris, 75019
FranceActive - Recruiting
Groupe Hospitalier Diaconesses-Croix Saint Simon,
Paris, 75020
FranceSite Not Available
Pitié-Salpetrière Hospital
Paris, 75013
FranceSite Not Available
Saint-Antoine Hospital
Paris, 75012
FranceActive - Recruiting
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