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TocILizumab in aorTitis in GCA (TILT)

Recruitingn/aAges 18 Years - anyAllGroupe français d'étude des Maladies Inflammatoir…
NCT06271018 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA). Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pai

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients ≥18 years * Signed informed consent * Affiliation with the French national social security system * Adequate and effective contraceptive measures * For women of childbearing age, a negative serum pregnancy test. * Diagnosis of GCA according to 2022 ACR/EULAR criteria * Active newly diagnosed or relapsing Aortitis related to GCA proved by imaging (Tep-scan, angio-CT or magnetic resonance imaging angiography) * No neoplasia * No contraindication to Tocilizumab Exclusion Criteria: * Pregnancy or breastfeeding ; * History of severe immunosuppression, HIV or HBsAg positive * Non response or intolerance to previous therapy with tocilizumab * Positive QuantiFERON test result (QFT-TBGIn-Tube) * Have received live vaccines within 3 months prior to the start of the trial * History of malignancy in the last 5 years * Severe renal impairment (creatinine clearance \<30mL/min/1.73m²) * Liver dysfunction defined as aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 at the upper limit of normal * Blood count abnormality: * Platelet count \< 50 x 10.3/mm3 * Neutropenia \< 1000/mm3 * Hemoglobin \< 8 g/dl
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What it tests

  • Not listed
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Where

1 site
Département de Medecine interne et d'immunologie clinique - hôpital La Pitié Salpetrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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