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Efficacy and safty study of combined treatment of methylprednisolone and methotrexate in active moderate to severe TAO patients

Efficacy and safty study of combined treatment of methylprednisolone and methotrexate in active moderate to severe TAO patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015933
Enrollment
Unknown
Registered
2018-04-29
Start date
2018-04-30
Completion date
Unknown
Last updated
2018-05-07

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:classic
2:MP+MTX

Sponsors

Dept. of Endocrine and Metabolic Diseases, Ruijin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients should meet all of following items: 1. Lid retraction with any one of the following: 1) Thyroid dysfunction; 2) Proptosis; 3) Optic nerve involvement; 4) Extraocular muscle involvement; 2. Thyroid dysfunction with any one of the following: 1) Proptosis; 2) Optic nerve involvement; 3) Extraocular muscle involvement; 3. Exclude cases with such ophthalmological signs caused by other diseases; 4. Moderate to severe patients defined by EUGOGO; 5. Clinical activity score (CAS)=3/7.

Exclusion criteria

Exclusion criteria: 1. treated with steroid within 3 months; 2. uncontrolled hypertension(SBP=160mmHg and/or DBP=100mmHg); 3. acute diabetic complication within 6 months or had severe chronic complications; 4. impaired renal function, CCr 2.5ULM, past severe liver diseases; 6. normal LFT with HBsAg(+) or anti-HCV(+) carriers; 7. GI ulcers.active TB; 8. severe electrolyte imbalance; 9. woman in pregnancy or lactation, or plan to be pregnant in 1 year.(obtain negative pregnancy test and avoid pregnant); 10. allergic to treatment; 11. encounter any conditions that would prevent the patient from adhering to protocol; l2. drug abuse or alcoholic in the past 5 years (drinking alcohol >35u/week, 1u=8g ethanol).

Design outcomes

Primary

MeasureTime frame
CAS;proptosis;diplopia grade;palpebrare;motility;QOL;ocular pressure;visual acuity;

Countries

China

Contacts

Public ContactWang Shu

Ruijin Hospital Affliated to Shanghai Jiaotong University School of Medicine

shuwang999@hotmail.com+86 13817804336

Outcome results

None listed

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