Recruiting NCT07117981
Describe the Progression of Inflammatory Orbitopathy and the Biological Progression of Patients Receiving Second-line Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Basedow Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Graves' Orbitopathy in Patients Failing Corticosteroid Therapy: Multicenter National Retrospective Study- Basedow
Overview
Describe the progression of inflammatory orbitopathy and the biological progression of patients receiving second-line treatment (immunosuppressants, radiotherapy, or biotherapy).
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
France · 9 centers
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts — Paris
- CHU Caen Normandie COTE DE NACRE — Caen
- CHU Lyon - Hospices Civils de Lyon — Lyon
- Hopital Saint Joseph — Marseille
- CHU de Montpellier — Montpellier
- CHU Nîmes — Nîmes
- Hopital Fondation de Rothschild — Paris
- CHU de Pontchaillou — Rennes
- … and 1 more center
Publications
- Chin YH, Ng CH, Lee MH, Koh JWH, Kiew J, Yang SP, Sundar G, Khoo CM. Prevalence of thyroid eye disease in Graves' disease: A meta-analysis and systematic review. Clin Endocrinol (Oxf). 2020 Oct;93(4):363-374. doi: 10.1111/cen.14296. Epub 2020 Aug 10. PMID 32691849
- Bartalena L, Baldeschi L, Dickinson A, Eckstein A, Kendall-Taylor P, Marcocci C, Mourits M, Perros P, Boboridis K, Boschi A, Curro N, Daumerie C, Kahaly GJ, Krassas GE, Lane CM, Lazarus JH, Marino M, Nardi M, Neoh C, Orgiazzi J, Pearce S, Pinchera A, Pitz S, Salvi M, Sivelli P, Stahl M, von Arx G, Wiersinga WM; European Group on Graves' Orbitopathy (EUGOGO). Consensus statement of the European Gro PMID 18299459
- Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479. PMID 34297684
- Vargas-Uricoechea H. Autoimmune Thyroid Disease and Differentiated Thyroid Carcinoma: A Review of the Mechanisms That Explain an Intriguing and Exciting Relationship. World J Oncol. 2024 Feb;15(1):14-27. doi: 10.14740/wjon1728. Epub 2023 Dec 9. PMID 38274715
- Lee JY, Lee MK, Lee JH, Kim K, Bae K, Sohn SY. Cancer Risks of Patients with Graves' Disease Who Received Antithyroid Drugs as Initial Treatment: A Nationwide Population-Based Analysis. Thyroid. 2024 Oct;34(10):1271-1279. doi: 10.1089/thy.2024.0178. Epub 2024 Sep 23. PMID 39228052
- Goodman RS, Johnson DB, Balko JM. Corticosteroids and Cancer Immunotherapy. Clin Cancer Res. 2023 Jul 14;29(14):2580-2587. doi: 10.1158/1078-0432.CCR-22-3181. PMID 36648402
- Prummel MF, Bakker A, Wiersinga WM, Baldeschi L, Mourits MP, Kendall-Taylor P, Perros P, Neoh C, Dickinson AJ, Lazarus JH, Lane CM, Heufelder AE, Kahaly GJ, Pitz S, Orgiazzi J, Hullo A, Pinchera A, Marcocci C, Sartini MS, Rocchi R, Nardi M, Krassas GE, Halkias A. Multi-center study on the characteristics and treatment strategies of patients with Graves' orbitopathy: the first European Group on Gra PMID 12720530
Identifiers
NCT: NCT07117981 · P23-05