Clinical Trial: A multicenter retrospective cohort study on the efficacy and safety with teprotumumab versus intravenous glucocorticoid for thyroid eye disease (Japan)

Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061392) titled 'A multicenter retrospective cohort study on the efficacy and safety with teprotumumab versus intravenous glucocorticoid for thyroid eye disease' on June 1.

Study Type: Observational

Primary Sponsor: Institute - Nagasaki University Hospital

Condition: Condition - Thyroid eye disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - There are no randomized controlled trials (RCTs) on the therapeutic effects of the novel treatment with teprotumumab and conventional treatment (steroid-pulse therapy) for active thyroid eye disease (TED), and no guidelines have been established for choosing between the two treatments. Therefore, the purpose of this study is to collect real-world data in Japan based on the medical records of patients with TED, and to clarify the differences in the efficacy and safety between the treatments. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with moderate to severe active TED based on the "Diagnostic Criteria and Treatment Guidelines for Thyroid Eye Disease 2023" (hereinafter referred to as the TED Treatment Guidelines) formulated by the Japan Thyroid Association and the Japan Endocrine Society, who have received tepromumab treatment or steroid pulse therapy, and who have been receiving treatment for at least 24 weeks since the start of treatment. 2. Patients who started treatment for TED between January 1, 2023 and March 31, 2026. 3. Patients who have undergone orbital MRI within 8 weeks prior to the start of treatment for active TED, and 12 weeks (8 weeks to 156 days) after the start of treatment, or/and 24 weeks (16 weeks to 31 weeks 6 days) after the start of treatment, or/and 48 weeks (32 weeks to 64 weeks). 4. Age: Must be an adult (18 years or older) at the start of TED treatment. 5. Sex: Not specified. 6. Inpatient/Outpatient: Not specified. 7. Nationality: Both parents must be Japanese citizens born in Japan, and the patient must be a Japanese citizen. Key exclusion criteria - 1. Patients with a history of external beam radiation therapy for TED, eyelid surgery, orbital decompression surgery, or strabismus surgery at baseline (start of TED treatment) 2. Patients with a history of local steroid injection into the eyelids or orbit within the past 8 weeks from baseline 3. Patients with a history of local botulinum toxin injection into the eyelids or extraocular muscles within the past 12 weeks from baseline 4. Patients with a history of high-dose steroid use (cumulative prednisolone equivalent > 1.5g) within the past 12 weeks from baseline, or steroid use (cumulative prednisolone equivalent > 0.5g) within the past 8 weeks 5. Patients with a history of rituximab, tocilizumab, satralizumab, batoclimab, fgaltigimod, or K1-70 administration during the data extraction period and prior to baseline 6. Patients currently participating in or who have participated in a teprotumumab clinical trial 7. Pregnant or lactating women at baseline or during the data extraction period 8. Patients with diseases involving abnormal IGF-1 secretion or action, such as growth hormone deficiency or acromegaly. 9. Patients who have expressed their refusal to participate in this study. 10. Other patients deemed unsuitable as research subjects by the principal investigator or staff member. Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 27 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069630

Disclaimer: Curated by HT Syndication.