Mycophenolate Plus Concomitant Steroids versus Orbital Radiotherapy Plus Concomitant Steroids in the treatment of intractable Graves’ ophthalmopathy: a randomised, controlled multicentre trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021199

Enrollment

Unknown

Registered

2019-02-01

Start date

2019-01-01

Completion date

Unknown

Last updated

2021-05-17

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

Conditions

Intractable Graves’ ophthalmopathy

Interventions

the group 1:oral steroid combined with mycophenolate, Oral methylprednisolone (0.4 mg / kg, for 4 weeks, gradually reduced to a maintenance dose of 4 mg qd) and oral mycophenolate mofetil (500 mg bid)

the group 2:oral steroid combined with orbital radiotherapy

Eligibility

Sex/Gender

All

Age

35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 35-65 years, and no birth planning in the past 1 years.; 2. Completion of the standard dose of intravenous methylprednisolone pulse therapy (0.5 qw) recommended by the EUGOGO guidelines for 6 weeks is not effective, or the cumulative dose of intravenous prednisolone in the 6 months is more than or equal to 3g and the effect is not effective; 3. Moderate to severe active TAO patients.

Exclusion criteria

Exclusion criteria: 1. history of glaucoma; 2. acute infection; 3. acute or chronic liver dysfunction (serum alanine aminotransferase (ALT) exceeds the upper limit of the normal reference range of 2.5 times); 4. acute or chronic renal impairment (urine protein (+++) or above in routine urine test; serum creatinine concentration increased above the upper limit of the normal reference range); 5. acute or chronic heart failure (NYHA grade 3 or higher); 6. uncontrolled diabetes (HbA1c = 8.0%) or associated with diabetic retinopathy; 7. uncontrolled hypertension (Bp = 160/100mmHg); 8. active peptic ulcer, or a history of gastrointestinal bleeding; 9. history of malignant tumors; 10. other immunosuppressants other than mycophenolate mofetil in the past 3 months; 11. Previously, serious adverse reactions (such as severe leukopenia, severe infection, etc.) occurred with immunosuppressive agents; 12. pregnant, breast-feeding women; 13. patients who have not taken effective contraception; 14. The investigator judged that the follow-up could not be adhered to.

Design outcomes

Primary

Measure	Time frame
Graves' Eye Disease Expert Group (EUGOGO) activity rating;	—

Countries

China

Contacts

Public ContactXu Mingtong

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

xumtong@126.com+86 13719335149

Outcome results

None listed

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