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Prospective comparison of sirolimus against corticosteroids in treatment of patients with active thyroid eye disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510166-27-01
Enrollment
70
Registered
2024-06-21
Start date
2024-06-22
Completion date
Unknown
Last updated
2025-06-05

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

Conditions

Thyroid eye disease

Brief summary

≥2 point reduction in Clinical Activity Score (CAS) from baseline at week 12.

Detailed description

≥ 2 mm reduction from baseline in proptosis in one eye at week 12., ≥ 2 mm reduction from baseline in vertical lid aperture in one eye at week 12., ≥ 1 class improvement of eye motility from baseline assessed by Gorman score at week 12., Gorman score: 1 = no diplopia, 2 intermittent diplopia, 3 = inconstant (gaze-evoked) diplopia, 4 = constant diplopia in primary or reading position, ≥ 6 points improvement in GO-QOL score

Interventions

DRUGSolu-Medrol S.A.B. (Sine Alcohol Benzylicus) 500 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Methylprednisolon

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
≥2 point reduction in Clinical Activity Score (CAS) from baseline at week 12.

Secondary

MeasureTime frame
≥ 2 mm reduction from baseline in proptosis in one eye at week 12., ≥ 2 mm reduction from baseline in vertical lid aperture in one eye at week 12., ≥ 1 class improvement of eye motility from baseline assessed by Gorman score at week 12., Gorman score: 1 = no diplopia, 2 intermittent diplopia, 3 = inconstant (gaze-evoked) diplopia, 4 = constant diplopia in primary or reading position, ≥ 6 points improvement in GO-QOL score

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026