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Prospective study on the efficacy of intravenous glucocorticoid therapy in Japanese patients with Graves' ophthalmopathy.

Prospective study on the efficacy of intravenous glucocorticoid therapy in Japanese patients with Graves' ophthalmopathy. - Steroid pulse therapy for Graves' ophthalmopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021482
Enrollment
300
Registered
2016-03-15
Start date
2016-03-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Graves&#39

Interventions

GO patients were randomly divided two groups. One group received 1.0g of methylprednisolone intravenously for 3 successive days and repeated every week up to 3 cycles. The other group received 0.5g o

Sponsors

Kurume University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with active and moderate, severe, sight threatening Graves' ophthalmopathy (GO). The activity of GO was assessed by CAS (more than 3 scores) or MRI.

Exclusion criteria

Exclusion criteria: Hepatitis B virus infection (carrier or HBcAb positive) Hepatitis C virus infection (HCVAb positive) Severe hypertension, heart disease, Psychiatric disease, HbA1c>8.0% Active tuberculosis Pregnancy Lactation

Design outcomes

Primary

MeasureTime frame
Efficacy: ophthalmological signs 1, 3, 6 and 12 months after pulse therapy.

Secondary

MeasureTime frame
Efficacy: CAS and MRI findings 1, 3, 6 and 12 months after pulse therapy. Safety: liver function test, glucose intolerance, peptic ulcer, psychiatric symptoms during and 1, 3, 6, 12 months after pulse therapy.

Countries

Japan

Contacts

Public ContactYuji Hiromatsu

Kurume University Medical Center Division of Endocrinology and Metabolism

yuji@med.kurume-u.ac.jp0942-22-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026