Using Tocilizumab for treating aortitis in Giant Cell Arteritis
Prospective, Observational Study Assessing Safety and Efficacy of Biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) With Active Aortitis
This study is testing if a new version of Tocilizumab can safely help people with Giant Cell Arteritis and active aortitis feel better while they are already on standard treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe français d'étude des Maladies Inflammatoires de loeil Academic / other |
| Drugs / interventions | Tocilizumab, prednisone |
| Locations | 1 site (Paris) |
| Trial ID | NCT06271018 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with active aortitis related to Giant Cell Arteritis, confirmed by imaging.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of severe immunosuppression or intolerance to Tocilizumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from aortitis related to GCA, potentially improving their quality of life and reducing severe complications.
How similar studies have performed: Other studies have shown promise in using Tocilizumab for GCA, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.