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

NCT07117981 | Recruiting

• 1 other identifier: P23-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Basedow Disease

Outcome Measures

Primary Outcomes (1)

• Response to second-line basedow treatment

  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.

  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

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The data collection concerns patients with Graves' orbitopathy who have received corticosteroid treatment and second-line treatment (immunosuppressants, biotherapy) since 2015, 2021, or 2022. A decision was made to limit the inclusion to patients who started second-line treatment between January 2022 and December 2023, with clinical follow-up until the end of 2024, in order to limit selection bias and ensure an adequate follow-up period. The inclusion period extends until June 2025.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

Study Sites (9)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, paris, 75012, France

RECRUITING

CHU Caen Normandie COTE DE NACRE

Caen, 14000, France

RECRUITING

CHU Lyon - Hospices Civils de Lyon

Lyon, 69002, France

RECRUITING

Hopital Saint Joseph

Marseille, 13285, France

RECRUITING

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

CHU Nîmes

Nîmes, 30900, France

RECRUITING

Hopital Fondation de Rothschild

Paris, 75019, France

RECRUITING

CHU de Pontchaillou

Rennes, 35000, France

RECRUITING

Hopital Civil / Nouvel Hopital Civil

Strasbourg, 67000, France

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 Group on Graves' orbitopathy (EUGOGO) on management of GO. Eur J Endocrinol. 2008 Mar;158(3):273-85. doi: 10.1530/EJE-07-0666. No abstract available.

  PMID: 18299459 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Graves' Orbitopathy experience. Eur J Endocrinol. 2003 May;148(5):491-5. doi: 10.1530/eje.0.1480491.

  PMID: 12720530 BACKGROUND

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Boris BIENVENU, DR

CONTACT

0140021738; bbienvenu@15-20.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 12, 2025
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)