Study Comparing Adalimumab and Mycophenolate Mofetil for Patients with Steroid-Dependent Non-Infectious Uveitis

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What is this study about?

This clinical trial is focused on studying a condition called non-infectious uveitis, which is an inflammation of the middle layer of the eye. The study is specifically looking at cases where the inflammation is dependent on steroids, a type of medication often used to reduce inflammation. The trial will compare the effectiveness and safety of two treatments: adalimumab, which is given as an injection, and mycophenolate mofetil, which is taken as a tablet. The purpose of the study is to see which treatment works better for managing this eye condition.

Participants in the study will receive either adalimumab or mycophenolate mofetil over a period of 36 weeks. Adalimumab will be administered as an injection under the skin, starting with a higher dose on the first day, followed by regular doses every two weeks. Mycophenolate mofetil will be taken orally every day. Some participants may also receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will monitor the participants’ eye health and any side effects they may experience during this time.

The trial aims to determine how well each treatment can control the inflammation in the eye and reduce the need for steroids. It will also assess the safety of the treatments by tracking any adverse effects. The study will last until 2027, with regular check-ups to evaluate the participants’ progress and the effectiveness of the treatments. This research could help improve treatment options for people with non-infectious uveitis who rely on steroids to manage their condition.

1 initial visit and randomization

Upon joining the study, eligibility criteria are confirmed. This includes a diagnosis of non-infectious uveitis and recent activity of the condition.

A written informed consent is required before any study-specific procedures.

Randomization occurs to assign the treatment group: either adalimumab or mycophenolate mofetil.

2 treatment initiation

For those receiving adalimumab, the initial dose is 80 mg on day 0, followed by 40 mg every 14 days from week 1 to week 35, administered as an injectable solution.

For those receiving mycophenolate mofetil, the dosage is 2 g per day, taken orally for 36 weeks.

3 monitoring and assessments

Regular assessments are conducted to monitor the condition and treatment response. These include evaluations of visual acuity, anterior chamber cell grade, and vitreous haze grade at specified intervals (weeks 4, 8, 12, 16, 20, 24, 30, 36, and 55).

Central retinal thickness and macular edema are also assessed using optical coherence tomography.

4 primary endpoint evaluation

The primary endpoint is assessed at 36 weeks. Treatment failure is defined by new active lesions, worsening visual acuity, increased anterior chamber cell grade, or inability to discontinue steroids between weeks 13 and 19.

5 secondary endpoint evaluation

Secondary endpoints include time to treatment failure, changes in visual function, and corticosteroid sparing measures, evaluated up to week 55.

Safety and tolerability are assessed by monitoring adverse events and treatment discontinuation.

6 study completion

The study is estimated to conclude by June 2027, with final assessments and data collection completed by this time.

Who Can Join the Study?

You must provide written, informed consent before any study-specific procedures are done.
You must be at least 18 years old.
You must have a diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye. This is a type of eye inflammation that is not caused by an infection.
You must have had recent activity of this eye condition in the last 3 months, even if you are taking more than 7mg of oral prednisone daily. Prednisone is a type of steroid medication. Recent activity can include:
- Active lesions in the back of the eye.
- Swelling in the central part of the retina, known as macular edema.
- At least 2+ cells in the front part of the eye, according to specific criteria.
- At least 2+ haze in the gel-like substance inside the eye, according to specific criteria.
You must have a chest X-ray or CT scan within 12 weeks before joining the study, showing no signs of active tuberculosis (TB), infection, or cancer.
If you have a positive test for TB exposure, you can still join if:
- Your chest X-ray shows no active TB disease.
- You have no symptoms of TB.
- If you have a latent TB infection and haven’t had preventive treatment, you must agree to complete such treatment.
If you are a female who can become pregnant, you must have a negative pregnancy test before joining.
If you can have children, you must agree to use effective birth control during the study and for a few months after stopping the study medications. This includes using two methods of contraception, such as:
- Hormonal birth control (pills, patches, or injections).
- Intrauterine devices (IUDs).
- Sterilization procedures like tubal occlusion or vasectomy.
- Condoms or sexual abstinence.
You must be affiliated with a social security system.

Who Cannot Join the Study?

Patients with any other eye disease that could affect the study results.
Patients who have had a recent eye surgery.
Patients with an active infection that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to the study medication.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with a serious medical condition that could affect their safety during the study.
Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Fondation A De Rothschild	Paris	France
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Quinze-Vingts National Ophthalmology Hospital	Paris	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Assistance Publique Hopitaux De Paris	Creteil	France
Centre Hospitalier Pasteur	Colmar	France
Azrdeilcyd Pbqbutcw Htogqxvz Dw Plshl	Le Kremlin-Bicetre	France
Cotyxb Hurpnudbhkg Uplcwgayeowgv De Dolus	Dijon	France
Cuud Dk Nqlrk	Vandoeuvre Les Nancy	France
Ghvbnqdvbz Hxvuhzderen Emqpehar Mzdorcnvdyd Soiwee Vjdc	Eaubonne	France
Cpoxty Haxbieudhmy Eg Ugxmrzooejggz Dq Lhamyxw	Limoges	France
Analxefcfy Piclietf Hxcpzfmt Dl Phnmt	Paris	France
Agjwjuuhmf Pokdwhug Hlajhmyh Db Mnutoxuza	Marseille	France
Chopip Hsxwxoiatyv Rbgielnh Utfjpvkaqentr Dq Ttghg	Tours	France
Cny Cnriz Ragnkwiwwko	Lyon	France
Ikiiuvnu du Clebiewtbpum Hjpyevjhtwv Uofbpaihcbeai du Sxvpd Edsapyg (bhodvou	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2023

Trial locations

Investigated drugs:

Adalimumab is a medication used in this study to treat non-infectious uveitis, which is an inflammation of the middle layer of the eye. It is administered through an injection under the skin. The goal of using adalimumab in this trial is to evaluate its effectiveness in reducing inflammation and dependency on steroids in patients with this eye condition.

Mycophenolate mofetil is another medication being tested in this study. It is taken orally and is commonly used to suppress the immune system. In this trial, mycophenolate mofetil serves as the standard treatment to manage non-infectious uveitis, aiming to control inflammation and reduce the need for steroid use.

Investigated diseases:

Uveitis

Non-infectious Uveitis – This is an inflammatory condition affecting the middle layer of the eye, known as the uvea. It can be classified into intermediate, posterior, and pan-uveitis based on the location of inflammation within the eye. The disease is characterized by redness, pain, light sensitivity, and vision changes. Over time, it can lead to complications such as cataracts, glaucoma, or retinal damage if not managed properly. The inflammation can cause a decrease in visual acuity and may result in the formation of new lesions in the retina. The condition often requires ongoing monitoring to assess changes in inflammation and visual function.

Trial ID:

2023-505112-38-00

Protocol code:

APHP211032

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study Comparing Adalimumab and Mycophenolate Mofetil for Patients with Steroid-Dependent Non-Infectious Uveitis

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Who Can Join the Study?

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