Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease (NCT04936854) | Clinical Trial Compass
RecruitingPhase 2
Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
Norway60 participantsStarted 2023-01-01
Plain-language summary
The purpose of this study is to determine whether Sirolimus is more effective and burdened with less side effects than conventional treatment with corticosteroids in patients with active thyroid eye disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* The participant want treatment for active thyroid eye disease and is willing to be included in the study
* Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS) ≥ 4 (on the 7-item scale)
* Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia
* Onset of active TED symptoms (as determined by participant records) within 9 months prior to inculsion
* Participants must be euthyroid with the Graves disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels \< 50% above or below the normal limits).
* Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the study
* Diabetic participants must have well-controlled stable disease (defined as HbA1C \< 9.0% with no new diabetic medication \[oral or insulin\] or more than a 10% change in the dose of a currently prescribed diabetic medication within 60 days prior to Screening)
* Women of childbearing potential (including those with an onset of menopause \<2 years prior to Screening, non-therapy-induced amenorrhea for \<12 months prior to Screening, or not surgically steril…
What they're measuring
1
Percentage of participants who were CAS categorical responders at week 12