Graves OphthalmopathyGONCT06693856
Multi-center Prospective Clinical Study on Glucocorticoid Pulse Therapy for Graves' Ophthalmopathy (GO)
A study testing High-Dose Methylprednisolone and Low-Dose Methylprednisolone in people with Graves Ophthalmopathy, run by Zou Junjie at 3 sites in China.
Trial summary
This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- High-Dose Methylprednisolone and Low-Dose Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily accept the study and sign the informed consent form.
- Age between 25 and 70 years old at the time of enrollment, both males and females are eligible.
- Newly diagnosed Graves' ophthalmopathy, moderate to severe active patients. The criteria for moderate to severe GO are: ① eyelid retraction ≥2mm; ② moderate to severe involvement of orbital soft tissues; ③ proptosis ≥20mm; ④ periodic or persistent diplopia. Meeting one of the above four criteria is sufficient.
- The criteria for active GO are: CAS score ≥4 points. Scoring criteria: ① spontaneous retro-ocular pain; ② pain on eye movement; ③ conjunctival congestion; ④ eyelid congestion; ⑤ chemosis of the conjunctiva; ⑥ swelling of the caruncle; ⑦ eyelid edema. One point is recorded for each of the above seven symptoms if present, and zero if absent.
- The onset of Graves' ophthalmopathy does not exceed 12 months, and those who have not been treated with glucocorticoids or other immunosuppressive agents.
- Women of childbearing age must use effective contraceptive measures.
- At the time of screening, hyperthyroidism in the study subjects should be basically controlled. Thyroid function should be normal or only mildly abnormal, defined as FT4 and FT3 levels within 50% of the upper and lower limits of the normal range. Mild thyroid dysfunction should be corrected as much as possible, and a normal thyroid function state should be maintained throughout the clinical trial period.
Who cannot join
- Pregnant women, women who are breastfeeding, or women planning to become pregnant during the trial period.
- Severe cardiac diseases such as myocardial infarction, unstable angina, and chronic heart failure.
- Known liver diseases, or alanine transaminase (ALT) levels more than 1.5 times the upper limit of normal.
- Chronic kidney disease, or serum creatinine >135 umol/L (>1.5 mg/dL).
- Individuals with diabetes, and HbA1c >9.0%.
- Individuals with a history of alcohol abuse or drug use.
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- Subjects with a white blood cell count <4.0×10^9/L, or a platelet count <80×10^9/L.
- Significant anemia (hemoglobin levels <110 g/L in males, <100 g/L in females).
- Patients with psychiatric disorders, or those who are non-cooperative.
- Individuals with optic nerve involvement requiring orbital decompression surgery. Defined as a decrease in vision by more than two lines in the past six months, or new visual field defects, or color vision deficiencies.
- Corneal ulcers, contraindications for glucocorticoid treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Shanghai Changzhen Hospital
Shanghai, Shanghai Municipality, 200003
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200438
Shanghai Longhua Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Different Methylprednisolone Pulse Therapy Regimens for the Treatment of Graves' Ophthalmopathy
This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the efficacy and safety of the two groups. Additionally, this study will extend the follow-up to 48 weeks to observe the recurrence rate after treatment in both groups, exploring the heterogeneity of the active course of Graves' ophthalmopathy.
Read the detailed description
Graves' ophthalmopathy (GO) is an organ-specific autoimmune disease closely related to the thyroid gland, typically manifested by proptosis, eyelid swelling, eye pain, and double vision. Mild GO may resolve with the control of hyperthyroidism, while moderate to severe GO can severely damage vision and require more aggressive treatment. Glucocorticoids are the first-line treatment for moderate to severe, active GO, and intravenous methylprednisolone is more effective than oral glucocorticoids. The 2021 clinical practice guidelines of the European Group on Graves' Orbitopathy (EUGOGO) recommend that the optimal dosage regimen for methylprednisolone is once a week for 12 weeks, with a cumulative dose of 4.5 grams. For the most severe cases, a higher cumulative dose of up to 8 grams can also be used as monotherapy.
Starting from the 1990s, the Endocrinology Department of Shanghai Changzheng Hospital began to admit patients with Graves' ophthalmopathy and initiated immunosuppressive pulse therapy, accumulating nearly 1000 cases of GO, making it the hospital with the most patients with Graves' ophthalmopathy in Shanghai and even nationwide. The monthly pulse therapy regimen has a high treatment response rate, a low relapse rate, and good safety. However, there are still a series of unresolved issues with glucocorticoid pulse therapy for Graves' ophthalmopathy. Firstly, the optimal cumulative dose of methylprednisolone has not been established. Secondly, the active course of Graves' ophthalmopathy varies greatly among individuals, with reports ranging from a few months to several years, and the pulse therapy has not yet been individualized. Thirdly, there is a significant difference in individual sensitivity to glucocorticoids; the fixed high-dose administration of methylprednisolone at 500mg per session lacks sufficient evidence. Calculating the single-dose administration based on body weight or surface area may be more reasonable.
The efficacy and safety of different dosage regimens of methylprednisolone pulse therapy for Graves' ophthalmopathy will be further explored. This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the efficacy and safety of the two groups. Additionally, this study will extend the follow-up to 48 weeks to observe the recurrence rate after treatment in both groups, exploring the heterogeneity of the active course of Graves' ophthalmopathy.
- Conditions
- Graves Ophthalmopathy
- Being tested
- High-Dose Methylprednisolone, Low-Dose Methylprednisolone
- Keywords
- Graves ophthalmopathy, methylprednisolone, therapy regimens
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose MethylprednisoloneDrug
Methylprednisolone 500mg, administered intravenously once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
Low-Dose MethylprednisoloneDrug
Methylprednisolone is administered at a dose of 1mg/kg, given as an intravenous injection once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| a high-dose group | Active comparator | methylprednisolone 500mg, D1-3, once every 4 weeks Receives: Drug: High-Dose Methylprednisolone |
| a low-dose group | Experimental | methylprednisolone 1mg/kg, D1-3, once every 4 weeks Receives: Drug: Low-Dose Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate, ORR
The percentage of subjects with improvement in Graves' ophthalmopathy at week 24.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (3)
CAS and proptosis
To assess the percentage of subjects in the high-dose group and the low-dose group at week 24 who have a reduction of ≥2 points in CAS (Clinical Activity Score) and a reduction of ≥2mm in proptosis compared to baseline, provided that there is no corresponding worsening in the contralateral eye (increase in CAS of ≥2 points or increase in proptosis of ≥2mm).
Measured: From enrollment to the end of treatment at 24 weeks
Clinical Activity Score
To assess the percentage of subjects in the high-dose group and the low-dose group at week 24 who have a CAS of 0 or 1 in the study eye.
Measured: From enrollment to the end of treatment at 24 weeks
proptosis
To assess the mean change in proptosis of the study eye from baseline to week 24 in the high-dose group and the low-dose group.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zou Junjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zou Junjie, Shanghai Changzheng Hospital
- Investigators
- Zou JJ Professor, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693856
- Sponsor's protocol ID
- 2024SL126
- Acronym
- GO
- Status last verified
- May 2025
- First submitted
- 14 Nov 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared data will include, but not be limited to, the participants' baseline characteristics, clinical measurements, medical history, clinical laboratory results, adverse events, as well as randomization results and treatment outcomes. Data will only be provided after application and approval.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Different Methylprednisolone Pulse Therapy Regimens for the Treatment of Graves' Ophthalmopathy
- ClinicalTrials.gov ID
- NCT06693856
- Acronym / sponsor ID
- GO / 2024SL126
- Conditions
- Graves Ophthalmopathy
- Keywords
- Graves ophthalmopathy, methylprednisolone, therapy regimens
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zou JunjieUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 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.
This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the efficacy and safety of the two groups. Additionally, this study will extend the follow-up to 48 weeks to observe the recurrence rate after treatment in both groups, exploring the heterogeneity of the active course of Graves' ophthalmopathy.
Detailed description
Graves' ophthalmopathy (GO) is an organ-specific autoimmune disease closely related to the thyroid gland, typically manifested by proptosis, eyelid swelling, eye pain, and double vision. Mild GO may resolve with the control of hyperthyroidism, while moderate to severe GO can severely damage vision and require more aggressive treatment. Glucocorticoids are the first-line treatment for moderate to severe, active GO, and intravenous methylprednisolone is more effective than oral glucocorticoids. The 2021 clinical practice guidelines of the European Group on Graves' Orbitopathy (EUGOGO) recommend that the optimal dosage regimen for methylprednisolone is once a week for 12 weeks, with a cumulative dose of 4.5 grams. For the most severe cases, a higher cumulative dose of up to 8 grams can also be used as monotherapy.
Starting from the 1990s, the Endocrinology Department of Shanghai Changzheng Hospital began to admit patients with Graves' ophthalmopathy and initiated immunosuppressive pulse therapy, accumulating nearly 1000 cases of GO, making it the hospital with the most patients with Graves' ophthalmopathy in Shanghai and even nationwide. The monthly pulse therapy regimen has a high treatment response rate, a low relapse rate, and good safety. However, there are still a series of unresolved issues with glucocorticoid pulse therapy for Graves' ophthalmopathy. Firstly, the optimal cumulative dose of methylprednisolone has not been established. Secondly, the active course of Graves' ophthalmopathy varies greatly among individuals, with reports ranging from a few months to several years, and the pulse therapy has not yet been individualized. Thirdly, there is a significant difference in individual sensitivity to glucocorticoids; the fixed high-dose administration of methylprednisolone at 500mg per session lacks sufficient evidence. Calculating the single-dose administration based on body weight or surface area may be more reasonable.
The efficacy and safety of different dosage regimens of methylprednisolone pulse therapy for Graves' ophthalmopathy will be further explored. This study plans to include newly diagnosed, active, moderate to severe Graves' ophthalmopathy patients, divided into a high-dose group (methylprednisolone 500mg, D1-3, once every 4 weeks) and a low-dose group (methylprednisolone 1mg/kg, D1-3, once every 4 weeks), with a treatment duration of 24 weeks to compare the efficacy and safety of the two groups. Additionally, this study will extend the follow-up to 48 weeks to observe the recurrence rate after treatment in both groups, exploring the heterogeneity of the active course of Graves' ophthalmopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a high-dose group | Active comparator | Drug: High-Dose Methylprednisolonemethylprednisolone 500mg, D1-3, once every 4 weeks |
| a low-dose group | Experimental | Drug: Low-Dose Methylprednisolonemethylprednisolone 1mg/kg, D1-3, once every 4 weeks |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily accept the study and sign the informed consent form.
- Age between 25 and 70 years old at the time of enrollment, both males and females are eligible.
- Newly diagnosed Graves' ophthalmopathy, moderate to severe active patients. The criteria for moderate to severe GO are: ① eyelid retraction ≥2mm; ② moderate to severe involvement of orbital soft tissues; ③ proptosis ≥20mm; ④ periodic or persistent diplopia. Meeting one of the above four criteria is sufficient.
- The criteria for active GO are: CAS score ≥4 points. Scoring criteria: ① spontaneous retro-ocular pain; ② pain on eye movement; ③ conjunctival congestion; ④ eyelid congestion; ⑤ chemosis of the conjunctiva; ⑥ swelling of the caruncle; ⑦ eyelid edema. One point is recorded for each of the above seven symptoms if present, and zero if absent.
- The onset of Graves' ophthalmopathy does not exceed 12 months, and those who have not been treated with glucocorticoids or other immunosuppressive agents.
Key exclusion criteria (11 listed)
- Pregnant women, women who are breastfeeding, or women planning to become pregnant during the trial period.
- Severe cardiac diseases such as myocardial infarction, unstable angina, and chronic heart failure.
- Known liver diseases, or alanine transaminase (ALT) levels more than 1.5 times the upper limit of normal.
- Chronic kidney disease, or serum creatinine >135 umol/L (>1.5 mg/dL).
- Individuals with diabetes, and HbA1c >9.0%.
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 |
|---|---|---|
| High-Dose MethylprednisoloneMethylprednisolone 500mg, administered intravenously once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period. | Drug | a high-dose group |
| Low-Dose MethylprednisoloneMethylprednisolone is administered at a dose of 1mg/kg, given as an intravenous injection once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period. | Drug | a low-dose group |
Primary outcome
Overall Response Rate, ORR
Time frame: From enrollment to the end of treatment at 24 weeks
The percentage of subjects with improvement in Graves' ophthalmopathy at week 24.
3 secondary outcomes
CAS and proptosis
Time frame: From enrollment to the end of treatment at 24 weeks
Clinical Activity Score
Time frame: From enrollment to the end of treatment at 24 weeks
proptosis
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Yes. The shared data will include, but not be limited to, the participants' baseline characteristics, clinical measurements, medical history, clinical laboratory results, adverse events, as well as randomization results and treatment outcomes. Data will only be provided after application and approval.
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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.
Zou JJ Professor principal investigator
Shanghai Changzheng Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dose Methylprednisolone and Low-Dose Methylprednisolone in people with Graves Ophthalmopathy, run by Zou Junjie at 3 sites in China.
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 11 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: enrolling by invitation, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
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?
Overall Response Rate, ORR (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.