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NCT Number: NCT07117981

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, paris, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Response to second-line basedow treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Boris BIENVENU, DR

CONTACT

[email protected]

0140021738

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Official study title

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

Acronym: HZN-IIT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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