Skip to content

Describe the Progression of Inflammatory Orbitopathy and the Biological Progression of Patients Receiving Second-line Treatment

Treatment of Graves' Orbitopathy in Patients Failing Corticosteroid Therapy: Multicenter National Retrospective Study- Basedow

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07117981
Acronym
HZN-IIT
Enrollment
100
Registered
2025-08-12
Start date
2024-11-01
Completion date
2025-12-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basedow Disease

Brief summary

Describe the progression of inflammatory orbitopathy and the biological progression of patients receiving second-line treatment (immunosuppressants, radiotherapy, or biotherapy).

Interventions

None listed

Sponsors

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Response to second-line basedow treatmentPatients 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 2025Practices 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.

Countries

France

Contacts

Primary ContactBoris BIENVENU, DR
bbienvenu@15-20.fr0140021738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026