Clinical Trials in France / NCT07117981
Recruiting
Observational
Describe the Progression of Inflammatory Orbitopathy and the Biological Progression of Patients Receiving Second-line Treatment
NCT07117981 · tracked via the Priya Life Science France tracker
Condition(s) studied
Basedow Disease
Study summary
Describe the progression of inflammatory orbitopathy and the biological progression of patients receiving second-line treatment (immunosuppressants, radiotherapy, or biotherapy).
Eligibility
Inclusion Criteria:
* Patients aged 18 and older with moderate to severe orbitopathy;
* Patients followed in endocrinology with the goal of achieving euthyroidism;
* Corticosteroid-resistant patients: patients who have received at least 3 weeks of treatment with 500 mg weekly corticosteroid boluses and have not shown improvement in the clinical activity score (CAS);
* Corticosteroid-dependent patients: relapse with a CAS of 3 or higher when decreasing or stopping corticosteroid therapy;
* Patients with a CAS ≥ 3 or CAS \<3 with moderate to severe orbitopathy (according to EUGOGO);
* Patients treated with immunotherapy, biotherapy, or radiotherapy as second-line treatment;
* Patients who are not opposed to the reuse of their health data.
Exclusion Criteria:
* Patients who have undergone bone or fat decompression surgery;
* Patients with severe corneal involvement (Grade B or C; NO SPECS classification);
* Patients with optic neuropathy (Grade B and C; NO SPECS classification);
* Patients who have received 1 gram corticosteroid boluses for dysthyroid orbitopathy;
* Patients who have opposed the reuse of their health data.
Primary outcome measure(s)
- Response to second-line basedow treatment — Patients who started a second-line treatment between January 2022 and December 2023, with clinical follow-up until the end of 2024, were included in order to minimize selection bias. inclusion period: until december 2025
Practices in France regarding the use of these second-line treatments appear to be heterogeneous, and their effectiveness has never been compared through randomized studies. investigators propose to collect and analyze the therapeutic outcomes of second-line treatment in patients with Graves' orbitopathy. The data collection concerns patients with Graves' orbitopathy who have received corticosteroid therapy and a second-line treatment (immunosuppressant, biotherapy) since 2022. Data from the medical records of patients included.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Paris | paris | Recruiting |
| CHU Caen Normandie COTE DE NACRE | Caen | France | Recruiting |
| CHU Lyon - Hospices Civils de Lyon | Lyon | France | Recruiting |
| Hopital Saint Joseph | Marseille | France | Recruiting |
| CHU de Montpellier | Montpellier | France | Recruiting |
| CHU Nîmes | Nîmes | France | Recruiting |
| Hopital Fondation de Rothschild | Paris | France | Recruiting |
| CHU de Pontchaillou | Rennes | France | Recruiting |
| Hopital Civil / Nouvel Hopital Civil | Strasbourg | France | Recruiting |
More Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07117981 on ClinicalTrials.gov ↗ ← All trials in France