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Muti-center clinical study comparing orbital radiation therapy or methotrexate in the treatment of moderate to severe active stage thyroid associated ophthalmopathy patients

Muti-center clinical study comparing orbital radiation therapy or methotrexate in the treatment of moderate to severe active stage thyroid associated ophthalmopathy patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015039
Enrollment
Unknown
Registered
2018-03-02
Start date
2018-03-29
Completion date
Unknown
Last updated
2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thyroid associated ophthalmopathy

Interventions

1:orbital radiation therapy
2:methotrexate

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age between 30-60 years old, no restriction for gender; 2. Diagnosed with moderate-severe TAO in active phase; 3. Normalized thyroid function for at least 1 months before included: including those who are taking anti hyperthyroidism drugs or without taking medication, FT3, FT4 normal, TSH normal or lower; 4. Body weight between 40-70 kg; 5. Informed consent signed; 6. Glucocorticoid treatment accumulative 4.5g insensitive.

Exclusion criteria

Exclusion criteria: 1. Severe disease of heart, liver and kidney function failure including myocardial ischemia or myocardial infarction, arrhythmia and heart failure; ALT, AST more than 1.5 times the upper limit of the normal value; limit; creatinine level over normal limit or eGFR < 60 ml/min/1.73 M2); 2. Gastric ulcer, gastric bleeding, diabetes or other autoimmune diseases, uncontrolled hypertension, tuberculosis, mental disease patients, glaucoma, diabetes, HIV infection or AIDS patients; 3. Patients allergic to glucocorticoid or methotrexate; 4. Patients with pregnancy test, in lactation; 5. Patients who received radioactive iodine therapy, vaccination hepatitis vaccine 3 months before the study; 6. Patients who received the systemic immunotherapy for TAO, including oral or intravenous corticosteroids, other immunosuppressive agents and orbital radiation, etc., 1 month before the study.

Design outcomes

Primary

MeasureTime frame
Overall Efficacy Rate;

Secondary

MeasureTime frame
Clinical Activity Score;

Countries

China

Contacts

Public ContactZhou Huifang

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

fangzzfang@163.com+86 021-63135606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026