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AzTrials

Basedow DiseaseHZN-IITNCT07117981

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

An observational study of Basedow Disease, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 9 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Basedow Disease
How many people
100 participants
Where
9 sitesFrance
Study dates
1 Nov 2024to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Boris BIENVENU, DR contact

0140021738

bbienvenu@15-20.fr

9 sites in 1 country

France9 sites, 9 recruiting

  • CHU Caen Normandie COTE DE NACRE

    Caen, 14000

    Jean Claude QUINTYN, DR, quintyn-jc@chu-caen.fr

    Recruiting

  • CHU Lyon - Hospices Civils de Lyon

    Lyon, 69002

    Juliette ABEILLON, DR, juliette.abeillon@chu-lyon.fr

    Recruiting

  • Hopital Saint Joseph

    Marseille, 13285

    Antoine POULER, DR, apoulet@hopital-saint-joseph.fr

    Recruiting

  • CHU de Montpellier

    Montpellier, 34295

    Yves-Marie PERS, PR, ym-pers@chu-montpellier.fr

    Recruiting

  • CHU Nîmes

    Nîmes, 30900

    Olivier GOHIER, DR, OLIVIER.GILLY@chu-nimes.fr

    Recruiting

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    Paris, paris, 75012

    Boris BIENVENU, DR

    Recruiting

  • Hopital Fondation de Rothschild

    Paris, 75019

    Clara BOUCHE, DR, cbouche@for.paris

    Recruiting

  • CHU de Pontchaillou

    Rennes, 35000

    Na'im BEN MILOUD, DR, Naim.BEN.MILOUD@chu-rennes.fr

    Recruiting

  • Hopital Civil / Nouvel Hopital Civil

    Strasbourg, 67000

    Lauriana SOLECKI, DR, lauriana.solecki@chru-strasbourg.fr

    Recruiting

Other trials in France

About this study

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

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

Conditions
Basedow Disease
Medical subject headings
Graves Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start1 Nov 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117981
Sponsor's protocol ID
P23-05
Acronym
HZN-IIT
Status last verified
Aug 2025
First submitted
29 Jul 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Each center remains the owner of its data, so it is possible to extract and send data from each center via the eCRF for theses or publications

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.

    PubMed 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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

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

    PubMed 12720530

Questions about this trial

What is this clinical trial studying?

An observational study of Basedow Disease, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boris BIENVENU, DR (0140021738, bbienvenu@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07117981, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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