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Study Comparing Sirolimus and Methylprednisolone for Patients with Active Thyroid Eye Disease

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Thyroid Eye Disease, a condition that affects the eyes and is often associated with Graves' disease. The study will compare two treatments: Sirolimus, which is taken as an oral solution, and corticosteroids, specifically Methylprednisolone, which is given as an injection. The purpose of the study is to determine if Sirolimus is more effective and has fewer side effects than the conventional treatment with corticosteroids.

Participants in the study will receive either Sirolimus or Methylprednisolone over a period of 12 months. The study will monitor changes in the condition of the eyes, such as a reduction in the Clinical Activity Score (CAS), which measures the activity of the disease, and improvements in eye symptoms like proptosis (bulging of the eyes) and lid retraction (pulling back of the eyelids). The study will also assess improvements in eye movement and overall quality of life related to the eye condition.

The trial aims to provide valuable information on the effectiveness and safety of Sirolimus compared to corticosteroids in treating active Thyroid Eye Disease. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the outcomes of the treatments. The results of this study could potentially lead to better treatment options for individuals affected by this eye condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria related to thyroid eye disease.
Participants must have a clinical diagnosis of Graves' disease with active thyroid eye disease, and meet other health and age requirements.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements, including the Clinical Activity Score (CAS) and other eye-related metrics.
This assessment helps in tracking changes throughout the study.
Step 3
Treatment phase
Participants receive either methylprednisolone or sirolimus as part of the treatment.
Methylprednisolone is administered as an intravenous infusion using Solu-Medrol S.A.B. 500 mg solution.
Sirolimus is taken orally as Rapamune 1 mg/mL solution.
The treatment duration and dosage are determined by the study protocol and monitored by the research team.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted to monitor the effectiveness of the treatment.
These assessments include measuring changes in the Clinical Activity Score (CAS), proptosis, lid aperture, and eye motility.
Step 5
End of treatment evaluation
At the end of the treatment phase, a comprehensive evaluation is performed to assess the overall impact of the treatment.
The primary goal is to achieve a reduction in the Clinical Activity Score (CAS) by at least 2 points from baseline at week 12.
Step 6
Final follow-up
A final follow-up is conducted to ensure the participant's health and to gather data on the long-term effects of the treatment.
Participants are monitored for any side effects and overall improvement in quality of life.

Who can join the trial?

9 criteria

Must have a clinical diagnosis of Graves' disease with active **Thyroid Eye Disease (TED)**, and a **Clinical Activity Score (CAS)** of 4 or more for the most affected eye. The CAS is a way to measure how active the eye disease is.
Must have moderate-to-severe active TED, which means it affects daily life but is not threatening to sight. This can include symptoms like eyelid pulling back by 2 mm or more, noticeable swelling of soft tissues around the eyes, eyes bulging 3 mm or more above the normal average for your race and gender, or double vision that comes and goes or is constant.
Must have thyroid hormone levels that are either normal or only slightly off. This means the thyroid disease should be under control, or if there is mild underactive or overactive thyroid, it should be corrected quickly and kept stable during the trial.
Must have started experiencing active TED symptoms within the last 6 months.
Women who can have children must have a negative pregnancy test before starting and during the study. They must use reliable birth control if sexually active with a male partner who hasn't had a vasectomy. Birth control should start at least one full cycle before the study and continue for 180 days after the last dose of the study drug.
Male participants must be surgically sterile or, if sexually active with a female partner who can have children, must use a barrier method of birth control from the start of the study until 180 days after the last dose of the study drug.
Must be at least 18 years old and younger than 80 years old.
Must be vaccinated according to national guidelines.
Must sign a consent form and agree to cooperate with the treatment and follow-up as required by the study rules and local regulations.

Who cannot join the trial?

8 criteria

Patients who do not have thyroid eye disease cannot participate. This is a condition where the eyes are affected due to thyroid problems.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have had recent eye surgery or other treatments that might affect the study cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helse Bergen HF
Verified
Bergen, Norway
St. Olavs Hospital HF
Verified
Trondheim, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Sirolimus
is a medication being tested in this trial to see if it can effectively treat patients with active thyroid eye disease. It is being compared to another treatment to determine if it has fewer side effects while still providing benefits to the patients.
Corticosteroids
are the conventional treatment used in this trial for patients with active thyroid eye disease. They are being used as a comparison to see if the new treatment, Sirolimus, can offer a better outcome with fewer side effects.

What is already known about the treatment

Sirolimus – Sirolimus is administered orally and is being studied for its effectiveness in treating thyroid eye disease. It is currently under investigation in clinical trials to compare its efficacy and side effects against traditional corticosteroid treatments. The main therapeutic indication for Sirolimus in this context is thyroid eye disease, a condition associated with inflammation and swelling around the eyes. At the molecular level, Sirolimus works by inhibiting a protein called mTOR, which plays a role in cell growth and immune response. It is classified pharmacologically as an immunosuppressant.

Investigated diseases

Thyroid Eye Disease – This condition is an autoimmune disorder that affects the muscles and other tissues around the eyes. It is often associated with an overactive thyroid gland, such as in Graves' disease. The disease can cause symptoms like bulging eyes, redness, swelling, and discomfort. As it progresses, it may lead to double vision and difficulty moving the eyes. The severity of symptoms can vary, and they may worsen over time. The disease can also lead to changes in appearance and vision problems if not managed properly.