Orbitopathy, GravesNCT06367517
Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease)
An observational study of Orbitopathy, Graves and Thyroid Eye Disease, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orbitopathy, Graves, Thyroid Eye Disease, Ophthalmopathy
- What is being tested?
- Tocilizumab
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 20 May 2021to 20 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with active, moderate-to-severe Graves' orbitopathy (GO), resistant to corticosteroid treatment, will be enrolled to participate in the study. They will be diagnosed and treated at a tertiarry referall center.
Who may be able to join
- Written informed consent
- Male or female, 18-80 years old
- Patients with active (Clinical Activity Score ≥ 3 in 7-item scale) and moderate-to-severe GO, diagnosed according to the EUGOGO guidelines, after the completion of MP pulse treatment, WITH
- o Deterioration of GO (in 1 or 2 eyes) when two of the following occurred:
- increase in palpebral aperture by at least 2 mm;
- deterioration in CAS by at least 2 points (7-point CAS)
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- increase in exophthalmos by at least 2 mm;
- worsening of diplopia (appearance or change in the degree)
- worsening in ocular motility by 8o
- o Incomplete response in both eyes to intravenous methylprednisolone pulse therapy; defined changes smaller than previously defined in any of the mentioned parameters.
- Euthyroid for at least 6-8 weeks (serum free hormone concentrations within 30% of normal range) on either anti-thyroid medications (tyonamides) to control hyperthyroidism or L-thyroxine for replacement therapy for hypothyroidism.
- Negative pregnancy test in women of fertile age.
- All female patients of fertile age must use a reliable contraceptive method to prevent pregnancy during the study period, and at least during a period of six months following the last dose of the investigational medicinal product.
Who cannot join
- Signs of sight-threatening TED (severe keratopathy, optic neuropathy)
- Pregnant or breastfeeding woman or woman planning to become pregnant during the study
- Patients who could need treatment with radioactive iodine or thyroidectomy during the study
- Treatment with any biological therapy at any time.
- Active infection.
- History of recurrent clinically significant infection or recurrent bacterial infections.
Show all 25Show fewer
- Positive quantiferon without documentation of treatment for tuberculosis (TB) infection or documentation of no need for such therapy.
- Required management of infections, as follows: currently on any suppressive therapy for a chronic infection, hospitalization for treatment of infection within 60 days before Day 0, use of parenteral antibiotics within 60 days before Day 0, use of oral antibiotics within 30 days before Day 0.
- History of intestinal ulceration or diverticulitis
- Patients with a history of chronic liver disease or liver disorders: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)
- HBsAg positive test.
- HBcAb positive test, regardless of HBsAb status, will undergo HBV DNA which, if positive, will be excluded. HbcAb positive, HbsAg negative patients with undetectable HBV DNA will receive antiviral prophylaxis throughout the immunosuppressive therapy.
- Hepatitis C antibody positive test at screening.
- Positive test for Human Immunodeficiency Virus (HIV) antibody at screening or historically. Denied consent to HIV testing.
- Absolute neutrophil count (ANC) < 2.0 × 109/L or a platelet count < 100×103/μL
- Alkaline phosphatase and bilirubin>1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is<35%).
- Cardiovascular or cerebrovascular disease clinically significant.
- Other serious chronic illness (including uncontrolled diabetes mellitus, renal disease, pulmonary disease, major depression).
- History of sarcoidosis.
- Primary or secondary immunodeficiency.
- History of IgE-mediated or non-IgE-mediated hypersensitivity.
- History of reactions or anaphylactic allergic severe human monoclonal antibodies, humanized or murine.
- Administration of live vaccines given within 30 days prior to administration of (Day 0) or concurrently with tocilizumab (during study).
- Splenectomy.
- Current drug or alcohol abuse or dependence.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Medicine and Endocrinology, Medical University of Warsaw
Warsaw, 02-097
About this study
Official title: Efficacy and Safety of Tocilizumab in Patients With Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease: Open, Prospective, Observational Study
The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease.
Read the detailed description
Graves' Orbitopathy (GO) is an autoimmune disease that involves orbital tissues, leading to temporary or permanent damage to the eye. Although GO is a rare condition, it negatively affects the quality of life in the majority of patients. In the majority of european centers, high-dose intravenous glucocorticoid (GCs) therapy remains the first-line treatment in patients with active, moderate-to-severe GO. However, GCs are effective in only 45-60% of patients, with a high probability of diseases relapse (10-40%) or disease progression to dysthyroid optic neuropathy (up to 10%). Due to limited efficacy of GCs, unpredictable relapses and progression of GO, the management of GO remains a challenge.
A few studies have demonstrated that interleukin-6 (IL-6) blockade with tocilizumab (TCZ) is effective in GC-refractory GO. However, the long-term outcomes of TCZ remain scarce.
Therefore, the investigators are planning to assess the therapy with Tocilizumab, regarding clinical outcomes and adverse events. The investigators plan to include a total of 30 patients with active, moderate-to-severe, corticosteroid-resistant GO over a period of approximately 4 years.
- Conditions
- Orbitopathy, Graves, Thyroid Eye Disease, Ophthalmopathy
- Being tested
- Tocilizumab
- Keywords
- Graves' disease, Graves' orbitopathy, Tocilizumab, Thyroid Eye Disease, Hyperthyroidism
- Medical subject headings
- Graves Ophthalmopathy, Eye Diseases, Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra
Tocilizumab administrated at a dose of 8 mg/kg, given once every four weeks
| Study group | Role | What they receive |
|---|---|---|
| Graves' orbitopathy | Patients with active, moderate to severe TED, without disease improvement after methylprednisolone pulse therapy in an intermediate-dose schedule (starting dose of 0.5 g once weekly for 6 weeks, followed by 0.25 g once weekly for 6 weeks) or high-dose regimens (a starting dose of 0.75 g once weekly for 6 weeks, followed by 0.5 g once weekly for 6 weeks) with or without concomitant radiotherapy. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease improvement
Proportion of patients improved at 16, 24 and 48 weeks as assessed by a composite ophthalmic score. A response to treatment will be considered positive in the case of an improvement of at least 2 of the following features in 1 eye, without concomitant deterioration in the other eye:
- decrease in eyelid aperture by at least 2 mm measured with a ruler
- decrease in proptosis by at least 2 mm measured with Hertel Exophthalmometer
- increase in eyelid motility by at least 8° assessed by ophthalmologist or improvement of Bahn-Gorman diplopia score (Grade I - intermittent diplopia, Grade II - Inconstant diplopia, Grade III - Constant diplopia)
- decrease in 7-item (spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, sweeling of caruncle or plica, swelling of eyelids, swelling of conjunctiva) clinical activity score (CAS) by at least 2 points.
Measured: at 16, 24 and 48 weeks
Improvement of quality of life
Improvement of quality of life according to the disease-specific quality of life questionnaire in Graves' orbitopathy (GO-QoL) at 16, 24 and 48 weeks. All Go-QoL questions will be scored as 'severely limited' (one point), a 'little limited' (two points), or 'not limited at all' (three points). The questions will be transformed from 0 to 100 by the following formula: total score= (raw score- 8)/16 x100. An improvement in QoL wil be considered, if there will be an increase of 6 or more points on either one (or both) the GO-QoL scales (functioning and appearance);
Measured: at 16, 24 and 48 weeks
Secondary outcomes (8)
Disease inactivation
Proportion of patients achieving response in reduction of clinical activity score (CAS) defined as reduction of ≥ 2 points from baseline in the study eye without deterioration (≥ 2 point increase) of CAS in the fellow eye
Measured: at 16, 24 and 48 weeks
Proportion of patients achieving response in specific GO signs and symptoms
- reduction of proptosis of least 2 mm without deterioration (≥ 2 mm increase) of proptosis in the fellow eye measured with Hertel Exophthalmometer.
- diplopia; proportion of participants with baseline diplopia > 0 and a reduction of ≥ 1 grade assessed according to Bahn-Gorman diplopia score (Grade I - intermittent diplopia, Grade II - Inconstant diplopia, Grade III - Constant diplopia)
- ocular motility; an increase of at least 8° assessed by ophthalmologist
- palpebral aperture; an increase of at least 2 mm measured with a ruler
- reduction in spontaneous or gaze-evoked retrobulbar pain - a binary scale (yes/no)
- reduction in swelling of eyelids (severe/moderate/mild), redness of eyelids (yes/no), redness of conjunctiva (yes/no), sweeling of caruncle or plica (yes/no), swelling of conjunctiva (yes/no)
Measured: at 16, 24 and 48 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence of adverse events, with severity determined according to NCI CTCAE v5.0
Measured: from 0 to 16 weeks
Decrease in concentration of thyrotropin receptor antibodies
Decrease in concentration of thyrotropin receptor antibodies
Measured: at 4, 8, 12, 16, 24 and 48 weeks
Decrease in levels of proinflammatory cytokines
Decrease in serum levels of interleukin-17a and interleukin-23
Measured: at 4, 8, 12, 16, 24 and 48 weeks
Number of the rehabilitative surgeries performed after immunosuppressive therapy
Rehabilitative surgery includes orbital decompression, squint surgery, lid lengthening, and blepharoplasty/browplasty
Measured: at 48 weeks
The rate of disease relapse
Proportion of patients with worsening of symptoms associated with GO after a period of improvement or stability. The relapse of the disease will be noted in case of a deterioration of at least 2 of the following features in 1 eye:
- increase in eyelid aperture by at least 2 mm measured with a ruler ,
- increase in exophthalmos by at least 2 mm measured with Hertel Exophthalmometer,
- decrease in eyelid motility by at least 8° assessed by ophthalmologist or deterioration of ≥ 1 grade in Bahn-Gorman diplopia score (Grade I - intermittent diplopia, Grade II - Inconstant diplopia, Grade III - Constant diplopia),
- increase in 7-item (spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, sweeling of caruncle or plica, swelling of eyelids, swelling of conjunctiva) clinical activity score (CAS) by at least 2 points.
Measured: at 48 weeks
Decrease in proptosis by at least 2 mm assessed using magnetic resonance imaging (MRI)
Measurement of exophthalmos (the distance between the interzygomatic line and the anterior surface of the globe - corneal apex) on axial T2W orbital MRI images performed at week 16 in comparison to baseline.
Measured: at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start20 May 2021
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orbitopathy, GravesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Bednarczuk, Medical University of Warsaw
- Investigators
- Tomasz Bednarczuk, MD, PHD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367517
- Sponsor's protocol ID
- KB/114/2022
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual data will be provided at request
Publications
Burch HB, Perros P, Bednarczuk T, Cooper DS, Dolman PJ, Leung AM, Mombaerts I, Salvi M, Stan MN. Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Association and the European Thyroid Association. Thyroid. 2022 Dec;32(12):1439-1470. doi: 10.1089/thy.2022.0251. Epub 2022 Dec 8.
PubMed 36480280Perez-Moreiras JV, Gomez-Reino JJ, Maneiro JR, Perez-Pampin E, Romo Lopez A, Rodriguez Alvarez FM, Castillo Laguarta JM, Del Estad Cabello A, Gessa Sorroche M, Espana Gregori E, Sales-Sanz M; Tocilizumab in Graves Orbitopathy Study Group. Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial. Am J Ophthalmol. 2018 Nov;195:181-190. doi: 10.1016/j.ajo.2018.07.038. Epub 2018 Aug 4.
PubMed 30081019Rymuza J, Kus A, Bialas-Niedziela D, Turczynska M, Kecik D, Bednarczuk T. Long-term remission of corticosteroid-resistant Graves' orbitopathy after therapy with tocilizumab. Endokrynol Pol. 2024;75(1):117-118. doi: 10.5603/ep.97224.
PubMed 38497401Bartalena 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 34297684Sawicka-Gutaj N, Bednarczuk T, Daroszewski J, Waligorska-Stachura J, Miskiewicz P, Sowinski J, Bolanowski M, Ruchala M. GO-QOL--disease-specific quality of life questionnaire in Graves' orbitopathy. Endokrynol Pol. 2015;66(4):362-6. doi: 10.5603/EP.2015.0046.
PubMed 26323474Rymuza J, Kus A, Nedeljkovic Beleslin B, Knezevic M, Bialas-Niedziela D, Turczynska M, Stojkovic M, Markovic B, Kecik D, Zarkovic M, Bednarczuk T. Tocilizumab in Active, Moderate-to-Severe, Glucocorticoid-Resistant Thyroid Eye Disease: An Open-Label Prospective Study in Two Independent Cohorts. Thyroid. 2026 Jun;36(6):654-664. doi: 10.1177/10507256261450089. Epub 2026 May 12.
PubMed 42117357
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tocilizumab in Patients With Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease: Open, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06367517
- Acronym / sponsor ID
- KB/114/2022
- Conditions
- Orbitopathy, Graves, Thyroid Eye Disease, Ophthalmopathy
- Keywords
- Graves' disease, Graves' orbitopathy, Tocilizumab, Thyroid Eye Disease, Hyperthyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease.
Detailed description
Graves' Orbitopathy (GO) is an autoimmune disease that involves orbital tissues, leading to temporary or permanent damage to the eye. Although GO is a rare condition, it negatively affects the quality of life in the majority of patients. In the majority of european centers, high-dose intravenous glucocorticoid (GCs) therapy remains the first-line treatment in patients with active, moderate-to-severe GO. However, GCs are effective in only 45-60% of patients, with a high probability of diseases relapse (10-40%) or disease progression to dysthyroid optic neuropathy (up to 10%). Due to limited efficacy of GCs, unpredictable relapses and progression of GO, the management of GO remains a challenge.
A few studies have demonstrated that interleukin-6 (IL-6) blockade with tocilizumab (TCZ) is effective in GC-refractory GO. However, the long-term outcomes of TCZ remain scarce.
Therefore, the investigators are planning to assess the therapy with Tocilizumab, regarding clinical outcomes and adverse events. The investigators plan to include a total of 30 patients with active, moderate-to-severe, corticosteroid-resistant GO over a period of approximately 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graves' orbitopathy | – | Drug: TocilizumabPatients with active, moderate to severe TED, without disease improvement after methylprednisolone pulse therapy in an intermediate-dose schedule (starting dose of 0.5 g once weekly for 6 weeks, followed by 0.25 g once weekly for 6 weeks) or high-dose regimens (a starting dose of 0.75 g once weekly for 6 weeks, followed by 0.5 g once weekly for 6 weeks) with or without concomitant radiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with active, moderate-to-severe Graves' orbitopathy (GO), resistant to corticosteroid treatment, will be enrolled to participate in the study. They will be diagnosed and treated at a tertiarry referall center.
Key inclusion criteria (13 listed)
- Written informed consent
- Male or female, 18-80 years old
- Patients with active (Clinical Activity Score ≥ 3 in 7-item scale) and moderate-to-severe GO, diagnosed according to the EUGOGO guidelines, after the completion of MP pulse treatment, WITH
- increase in palpebral aperture by at least 2 mm;
- deterioration in CAS by at least 2 points (7-point CAS)
Key exclusion criteria (25 listed)
- Signs of sight-threatening TED (severe keratopathy, optic neuropathy)
- Pregnant or breastfeeding woman or woman planning to become pregnant during the study
- Patients who could need treatment with radioactive iodine or thyroidectomy during the study
- Treatment with any biological therapy at any time.
- Active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RoActemraTocilizumab administrated at a dose of 8 mg/kg, given once every four weeks | Drug | Graves' orbitopathy |
Primary outcome
Disease improvement
Time frame: at 16, 24 and 48 weeks
Proportion of patients improved at 16, 24 and 48 weeks as assessed by a composite ophthalmic score. A response to treatment will be considered positive in the case of an improvement of at least 2 of the following features in 1 eye, without concomitant deterioration in the other eye: * decrease in eyelid aperture by at least 2 mm measured with a ruler * decrease in proptosis by at least 2 mm measured with Hertel Exophthalmometer * increase in eyelid motility by at least 8° assessed by ophthalmologist or improvement of Bahn-Gorman diplopia score (Grade I - intermittent diplopia, Grade II - Inconstant diplopia, Grade III - Constant diplopia) * decrease in 7-item (spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, sweeling of caruncle or plica, swelling of eyelids, swelling of conjunctiva) clinical activity score (CAS) by at least 2 points.
Improvement of quality of life
Time frame: at 16, 24 and 48 weeks
Improvement of quality of life according to the disease-specific quality of life questionnaire in Graves' orbitopathy (GO-QoL) at 16, 24 and 48 weeks. All Go-QoL questions will be scored as 'severely limited' (one point), a 'little limited' (two points), or 'not limited at all' (three points). The questions will be transformed from 0 to 100 by the following formula: total score= (raw score- 8)/16 x100. An improvement in QoL wil be considered, if there will be an increase of 6 or more points on either one (or both) the GO-QoL scales (functioning and appearance);
8 secondary outcomes
Disease inactivation
Time frame: at 16, 24 and 48 weeks
Proportion of patients achieving response in specific GO signs and symptoms
Time frame: at 16, 24 and 48 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: from 0 to 16 weeks
Decrease in concentration of thyrotropin receptor antibodies
Time frame: at 4, 8, 12, 16, 24 and 48 weeks
Decrease in levels of proinflammatory cytokines
Time frame: at 4, 8, 12, 16, 24 and 48 weeks
Number of the rehabilitative surgeries performed after immunosuppressive therapy
Time frame: at 48 weeks
The rate of disease relapse
Time frame: at 48 weeks
Decrease in proptosis by at least 2 mm assessed using magnetic resonance imaging (MRI)
Time frame: at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 36480280Burch HB, Perros P, Bednarczuk T, Cooper DS, Dolman PJ, Leung AM, Mombaerts I, Salvi M, Stan MN. Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Association and the European Thyroid Association. Thyroid. 2022 Dec;32(12):1439-1470. doi: 10.1089/thy.2022.0251. Epub 2022 Dec 8.
- Background: PubMed 30081019Perez-Moreiras JV, Gomez-Reino JJ, Maneiro JR, Perez-Pampin E, Romo Lopez A, Rodriguez Alvarez FM, Castillo Laguarta JM, Del Estad Cabello A, Gessa Sorroche M, Espana Gregori E, Sales-Sanz M; Tocilizumab in Graves Orbitopathy Study Group. Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial. Am J Ophthalmol. 2018 Nov;195:181-190. doi: 10.1016/j.ajo.2018.07.038. Epub 2018 Aug 4.
- Background: PubMed 38497401Rymuza J, Kus A, Bialas-Niedziela D, Turczynska M, Kecik D, Bednarczuk T. Long-term remission of corticosteroid-resistant Graves' orbitopathy after therapy with tocilizumab. Endokrynol Pol. 2024;75(1):117-118. doi: 10.5603/ep.97224.
- Background: PubMed 34297684Bartalena 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.
- Background: PubMed 26323474Sawicka-Gutaj N, Bednarczuk T, Daroszewski J, Waligorska-Stachura J, Miskiewicz P, Sowinski J, Bolanowski M, Ruchala M. GO-QOL--disease-specific quality of life questionnaire in Graves' orbitopathy. Endokrynol Pol. 2015;66(4):362-6. doi: 10.5603/EP.2015.0046.
- Results publication: PubMed 42117357Rymuza J, Kus A, Nedeljkovic Beleslin B, Knezevic M, Bialas-Niedziela D, Turczynska M, Stojkovic M, Markovic B, Kecik D, Zarkovic M, Bednarczuk T. Tocilizumab in Active, Moderate-to-Severe, Glucocorticoid-Resistant Thyroid Eye Disease: An Open-Label Prospective Study in Two Independent Cohorts. Thyroid. 2026 Jun;36(6):654-664. doi: 10.1177/10507256261450089. Epub 2026 May 12.
- Individual participant dataSharing planned: Undecided. Individual data will be provided at request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Bednarczuk, MD, PHD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbitopathy, Graves and Thyroid Eye Disease, run by Medical University of Warsaw at 1 site in Poland.
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 13 inclusion and 25 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: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease improvement (time frame: at 16, 24 and 48 weeks). The study lists 2 primary outcomes in all. 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 NCT06367517, which also lists 6 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 4 Jun 2026.