Study on the Effectiveness of Baricitinib for Patients with Refractory Non-Infectious Uveitis

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a medication called baricitinib in treating a specific eye condition known as non-infectious non-anterior uveitis. This condition involves inflammation in parts of the eye that are not at the front and is not caused by an infection. The trial is particularly interested in cases where the condition has not improved with other treatments, specifically two types of biological therapies, which are advanced treatments that target specific parts of the immune system.

The purpose of the study is to evaluate how well baricitinib, which is a type of medication known as a JAK inhibitor, works in managing this challenging eye condition. Participants in the study will take baricitinib in the form of film-coated tablets, either 2 mg or 4 mg, taken orally. The study will also involve the use of other medications, such as prednisone, a type of steroid, and fluorescein sodium, which is used in eye examinations. Some participants may receive a placebo, which looks like the real medication but does not contain the active ingredient.

Throughout the study, participants will be monitored over a period of six months to assess changes in their condition. This will include regular eye examinations to check for improvements in inflammation and other symptoms. The study aims to see if baricitinib can help reduce the need for other medications, like steroids, and improve overall eye health. Participants will have their vision and eye inflammation checked at various points during the study to track any changes and improvements.

1 initial assessment

Upon joining the study, an initial ophthalmologic assessment is conducted to establish a baseline for visual acuity and inflammation levels in the eyes.

This assessment includes a slit-lamp examination and optical coherence tomography to measure central macular thickness.

2 medication administration

The treatment involves taking baricitinib orally. The dosage is either 4 mg or 2 mg film-coated tablets, depending on the specific requirements of the study.

Additionally, prednisone is administered orally in the form of 5 mg tablets.

The exact dosage and frequency of these medications are determined by the study protocol and the patient’s specific condition.

3 follow-up assessments

Follow-up assessments are scheduled at 1 month, 3 months, and 6 months after the start of treatment.

These assessments include measuring changes in visual acuity, anterior chamber inflammation, and vitreous inflammation using the SUN scale.

Fluorescein angiography is performed to analyze vasculitis lesions, and optical coherence tomography is used to monitor changes in central macular thickness.

4 primary endpoint evaluation

The primary endpoint is evaluated at 6 months to determine partial remission of the condition.

In cases of bilateral eye involvement, the eye with the most severe condition is chosen for evaluation.

5 secondary endpoint evaluation

Secondary endpoints are assessed at 1 month, 3 months, and 6 months.

These include changes in visual acuity, inflammation levels, and corticosteroid dosages, as well as the correction of cystoid macular edema.

Who Can Join the Study?

Have a diagnosis of non-anterior non-infectious uveitis that does not respond to two types of treatments called biotherapy (anti-TNF alpha and tocilizumab). This means the condition is either still active or requires ongoing use of a medication called corticosteroids at a dose of 10 mg or more per day for at least 3 months.
Stop using biotherapy and other immune system-affecting medications (like mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days before joining the study.
Be an adult who has read and understood the study information and signed the consent form.
Be part of a social security plan.
Be under 65 years old.
If female and able to have children, use effective birth control (like birth control pills, an intrauterine device, or have had a tubal ligation) for at least 4 weeks before joining, during the study, and for 1 week after stopping the study treatment. Also, have a negative pregnancy test at the start of the study.
If female and unable to have children due to surgery (no ovaries, uterus, or both fallopian tubes removed) or menopause (no periods for at least 12 months not due to medical reasons), you can participate.
Have a negative test for a condition called latent TB (tuberculosis) within the last 6 months and a normal chest x-ray within the last 3 months. If you had latent TB before and it was treated, a positive test is acceptable.
Have tests showing no active infection with HIV, HCV (hepatitis C), and HBV (hepatitis B) within the last month.

Who Cannot Join the Study?

Patients with an active non-anterior non-infectious uveitis cannot participate. This means if you have a type of eye inflammation that is not at the front of the eye and is not caused by an infection, you are not eligible.
Patients who have not tried at least two different types of treatments called biotherapy (specifically anti-TNF alpha and tocilizumab) for their condition are excluded. Biotherapy refers to treatments that use substances made from living organisms to treat disease.
Patients who are not between the ages of 3 and 18 years old cannot participate.
Both males and females are eligible, but if you do not identify as either, you may not be eligible.
If you are part of a vulnerable population, which means you might need special protection or care, you may not be eligible. This could include groups like children, pregnant women, or people with certain disabilities.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Hopital Huriez	Lille	France
Cmx Cnvqj Rmfunyehqfd	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Baricitinib is a medication used in this trial to treat non-infectious non-anterior uveitis, which is a type of eye inflammation. It works by inhibiting certain enzymes known as JAK1 and JAK2, which are involved in the inflammatory process. This medication is being tested for its effectiveness in patients whose condition has not improved with other treatments, specifically two lines of biotherapy, including anti-TNF alpha and tocilizumab.

Non-infectious non-anterior uveitis – This is an inflammatory condition affecting the middle layer of the eye, specifically excluding the front part. It is not caused by an infection and can lead to symptoms such as eye redness, pain, and blurred vision. The inflammation can affect one or both eyes and may result in complications if not managed properly. Over time, the condition can cause structural changes in the eye, potentially impacting vision. The disease can be persistent and may require ongoing management to control inflammation and prevent further damage.

Trial ID:

2024-513802-77-00

Protocol code:

2020/420/HP

NCT ID:

NCT05651880

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Baricitinib for Patients with Refractory Non-Infectious Uveitis

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