Using Tocilizumab for treating aortitis in Giant Cell Arteritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the safety and efficacy of a biosimilar of Tocilizumab in patients with Giant Cell Arteritis (GCA) who have active aortitis. Conducted across 14 reference centers in France, the study involves monitoring patients who meet specific inclusion criteria and are receiving standard care, including a stable dose of oral corticosteroids. Participants will be followed for up to two years, with regular assessments of inflammation markers, adverse events, and imaging studies to evaluate treatment response.

Why it matters

Who can join: the full rules

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

Where it's running

• Département de Medecine interne et d'immunologie clinique - hôpital La Pitié Salpetrière
  Paris, France Recruiting

Study contacts

• Study coordinator: David SAADOUN, Professor
• Email: david.saadoun@aphp.fr
• Phone: +33142178042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.