Tracking inflammatory orbitopathy progression in people receiving second-line treatments

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 follows adults with moderate to severe Basedow (Graves') orbitopathy who are treated with second-line therapies including immunosuppressants, radiotherapy, or biologic agents. Clinical activity scores (CAS), imaging data, and biological markers will be collected longitudinally to document clinical and biological progression. Eligible patients are corticosteroid-resistant or corticosteroid-dependent and are managed at participating French centers; patients with prior orbital decompression or severe corneal/optic nerve involvement are excluded. The study does not assign treatments but records real-world management and requires patient consent for reuse of health data.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Boris BIENVENU, DR
• Email: bbienvenu@15-20.fr
• Phone: 0140021738

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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.