TocILizumab in aorTitis in GCA (TILT)

Launched by GROUPE FRANÇAIS D'ÉTUDE DES MALADIES INFLAMMATOIRES DE LOEIL · Feb 14, 2024

Keywords

ClinConnect Summary

The TILT trial is an observational study being conducted in France to evaluate the safety and effectiveness of a biosimilar version of tocilizumab in treating aortitis related to Giant Cell Arteritis (GCA). GCA is a condition that causes inflammation of large blood vessels, especially affecting older adults. Aortitis, which is inflammation of the aorta (the main artery that carries blood from the heart), can lead to serious symptoms like fever, weight loss, and chest pain. This study aims to learn more about how well tocilizumab works in reducing these symptoms and improving inflammation, especially using advanced imaging techniques to assess its effects.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of GCA with active aortitis demonstrated through imaging tests. They should also be able to provide informed consent and meet certain health criteria. Participants will receive treatment with tocilizumab alongside low-dose steroids and will be monitored for their clinical progress and any changes in their condition. This study is crucial as it seeks to provide new insights into the treatment of aortitis in GCA, which could lead to better care for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• 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