In short
Currently, there is 1 ongoing clinical trial for patients with chronic non-infectious uveitis. This trial is taking place in France and is investigating an adjusted dosing strategy for adalimumab, a medication used to control inflammation in the eye. The study aims to find better ways to maintain treatment response while preventing infections.
Clinical trial locations
Study on Adjusting Adalimumab Treatment for Patients with Chronic Non-Infectious Uveitis
This trial is exploring a new way to manage treatment for patients with chronic non-infectious uveitis, which is inflammation of the eye not caused by an infection. The study focuses on patients who have already responded well to treatment with adalimumab, a medication that reduces inflammation.
Who can participate:
- Adults aged 18 years or older
- Patients diagnosed with chronic non-infectious uveitis in at least one eye
- Those who have had a complete response to eye treatment for at least 48 weeks (or 96 weeks for Behçet's disease-related uveitis)
- Currently taking adalimumab 40 mg every 14 days for at least 24 weeks
- Have not received systemic corticosteroid therapy for at least 12 weeks
- Must be covered by social security and willing to sign a consent form
Who cannot participate:
- Patients who have not achieved complete symptom improvement
- Patients with an active infection
- Those outside the specified age range
- Vulnerable populations requiring special protection
What the trial involves: The main goal of this study is to test whether adjusting the timing of adalimumab doses based on drug levels in the blood can help maintain eye health and prevent infections over 48 weeks. This approach, called therapeutic drug monitoring, will be compared to the standard way of giving the medication at fixed intervals.
Participants will receive adalimumab injections under the skin using either a pre-filled syringe or pen. Throughout the study, patients will be monitored regularly at weeks 0, 12, 24, 36, and 48. During these visits, doctors will check for eye health, measure drug levels in the blood, test for antibodies against adalimumab, and assess quality of life using a vision-related questionnaire.
The investigational drug: Adalimumab works by blocking a substance called tumor necrosis factor-alpha (TNF-alpha), which causes inflammation in the body. By reducing this inflammation, adalimumab helps keep the eye condition under control and prevents flare-ups. The trial aims to determine if monitoring drug levels and adjusting doses accordingly can provide better outcomes for patients compared to the conventional fixed-dose approach.
Summary
There is currently one clinical trial available for patients with chronic non-infectious uveitis, located in France. This study represents an important step in understanding how to better manage long-term treatment with adalimumab by personalizing the dosing schedule based on individual patient needs. The focus on therapeutic drug monitoring may offer insights into more efficient ways to maintain treatment response while minimizing the risk of infections. Patients who have achieved stable disease control and are interested in participating should discuss this opportunity with their healthcare provider to determine if they meet the eligibility criteria.
