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Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease

Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease - Optimal antithyroid medication dosage reduction for patients with moderate to severe Graves' disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052937
Enrollment
76
Registered
2023-11-29
Start date
2024-03-01
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

Patients with moderate to severe Graves&#39
disease (blood FT4 level above 5.0 ng/dL) who started treatment with MMI 15 mg + KI 50 mg, then reduced the dose from MMI. Patients with moderate to severe Graves&#39
disease (blood FT4 level above 5.0 ng/dL) who started treatment with MMI 15 mg + KI 50 mg, then reduced the dose from KI.

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with untreated Graves' disease who plan to attend the facilities participating in this study will be eligible. (1) Patients who are between 18 and 80 years of age at the time of consent. (2) Patients with a confirmed diagnosis of moderate to severe Graves' disease (blood FT4 above 5.0 ng/dL) and who will start treatment with MMI 15 mg + KI 50 mg. (3) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclusion criteria

Exclusion criteria: Patients with untreated Graves' disease who plan to attend a facility participating in this study will be included. (1) Pregnant women, lactating women, and patients who plan to become pregnant within 2 years (2) Patients with untreated Graves' disease who may have thyroid crisis (3) Patients who have received curative treatment for Graves' disease (surgery, intra-iodine radioiodine therapy) in the past (4) Patients receiving immunosuppressive therapy or drugs that affect thyroid function (amiodarone, lithium carbonate, immune checkpoint drugs) (5) Other patients deemed inappropriate as research subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Relapse of thyrotoxicosis during and after discontinuation of dose reduction Secondary endpoints: percent change in thyroid volume, percent change in TRAb titer, remission rate at 2 years—

Countries

Japan

Contacts

Public ContactUchida Toyoyoshi

Juntendo University Graduate School of Medicine Department of Metabolism & Endocrinology

uchitoyo@juntendo.ac.jp+81-3-5802-1579

Outcome results

None listed

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