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Compares treatment options for Thyroid-Associated Ophthalmopathy
Official title Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
ClinicalTrials.gov ID: NCT04936854
What this study is testing
What is Sirolimus 1 mg Oral Tablet?
Sirolimus 1 mg Oral Tablet is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thyroid-associated ophthalmopathy.
Also referred to as Rapamycin, Rapamune.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
You likely can't join if
- The participant dont want treatment for active thyroid eye disease or dont want to participate in the study
- Decreased vision due to optic neuropathy as defined by a significant decrease in best corrected visual acuity, new visual field defect, or color...
- Corneal decompensation unresponsive to medical management
- Previous orbital irradiation or surgery for TED Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1 g of...
- Corticosteroid use for conditions other than TED within 4 weeks prior to inclusion (topical steroids for dermatological conditions and inhaled...
- Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the clinical trial; however, taking a...
See the full eligibility 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...
- 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...
- 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 sterile [absence of ovaries...
- Male participants must be surgically sterile or, if sexually active with a female partner of childbearing potential, must agree to use barrier contraceptive method from Screening through 180 days after the last dose of...
- Active Influenza and Pneumococcal vaccines
- The participant dont want treatment for active thyroid eye disease or dont want to participate in the study
- Decreased vision due to optic neuropathy as defined by a significant decrease in best corrected visual acuity, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months
- Corneal decompensation unresponsive to medical management
- Previous orbital irradiation or surgery for TED Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED. Previous steroid use (IV or oral)...
- Corticosteroid use for conditions other than TED within 4 weeks prior to inclusion (topical steroids for dermatological conditions and inhaled steroids are allowed)
- Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the clinical trial; however, taking a multivitamin that includes selenium and/or biotin is allowed
- Use of any other non-steroid immunosuppressive including agent, new biologic drugs within 3 months prior to Screening
- Use of an investigational agent for any condition within 60 days prior to inclusion or anticipated use during the course of the trial
- Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results
- Bleeding diathesis that in the judgment of the Investigator would preclude inclusion in the clinical trial
- Malignant condition in the past 12 months (except successfully treated basal/squamous cell carcinoma of the skin)
- Pregnant or lactating women
- Current drug or alcohol abuse, or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the participant
- Biopsy-proven or clinically suspected inflammatory bowel disease
- Known hypersensitivity to any of the components Sirolimus.
- Any other condition that, in the opinion of the Investigator, would preclude inclusion in the study
- Previous enrollment in this study
- Human immunodeficiency virus (HIV), tuberculosis, hepatitis C or hepatitis B infections
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Hordaland, Norway
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Hordaland, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.