Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis
This study is for adults with severe sarcoidosis that has been well-controlled by a medicine called infliximab for at least six months. Sarcoidosis is a condition where tiny clumps of cells, called granulomas, can form in various organs of the body. Infliximab helps to keep the disease calm. We want to find out if it's better to keep taking infliximab (the 'REMAIN' group) or if it's safe to stop it (the 'STOP' group) once your sarcoidosis is stable. People will be randomly chosen for one of these two groups. We will compare how well people in both groups stay in remission to understand the best treatment approach.
At a glance
What is this study about?
This study is investigating the best way to manage severe sarcoidosis when it's under control with a treatment called infliximab. Sarcoidosis is a condition that can affect many parts of the body, causing small lumps called granulomas to form. For some people, these lumps can cause significant problems and don't respond to usual treatments.
Infliximab is a strong medicine often used when other treatments haven't worked. It helps to calm down the body's overactive immune system. While infliximab can be very effective, doctors aren't sure how long people should keep taking it once their sarcoidosis is stable. Some worry that stopping the medicine might cause the sarcoidosis to flare up again.
This study aims to find out if continuing to take infliximab for a longer period is better for preventing the disease from returning, compared to stopping it. By comparing two groups of people – one that continues treatment and one that stops – we hope to gather important information that will help doctors and patients make better decisions about long-term treatment for sarcoidosis.
Key takeaways
- This study evaluates stopping vs. continuing infliximab for stable sarcoidosis.
- It aims to find the best long-term treatment strategy.
- Participants will be randomly assigned to one of two groups.
- It involves regular follow-up visits and health checks.
- Learning from this study could help future sarcoidosis patients.
Who may be eligible?
This study is designed for adults aged 18 or over who have sarcoidosis. You must have had a confirmed diagnosis of sarcoidosis, meaning small clumps of cells (granulomas) were found in at least one organ, and other similar conditions have been ruled out. You also need to have been taking infliximab for at least six months, with your sarcoidosis currently stable and under control. Your steroid dose must also be low (10mg or less per day) for the past six months, and your disease should show no signs of activity during that time.
There are several reasons why you might not be able to join the study. These include if you are pregnant or breastfeeding, have an active infection, or have certain serious heart, liver, or kidney problems. You also cannot participate if you've had cancer in the last five years (unless it was a certain type of skin cancer) or if you've had a positive test for tuberculosis without having been treated for it. It's also important that you can understand the study information and provide your consent, and for women and men, agree to use effective contraception during the study and for six months after.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a confirmed diagnosis of sarcoidosis?
- Have you been taking infliximab for at least 6 months?
- Is your sarcoidosis currently stable and well-controlled?
- Are you taking 10mg or less of steroids per day?
- Are you able to use effective contraception if needed?
What does participation involve?
If you join this study, it will involve being randomly assigned to one of two groups: either you'll continue taking infliximab (REMAIN group) or you'll stop taking it (STOP group). You have an equal chance of being in either group. Before joining, the study team will check that you meet all the requirements, and you'll receive full information and have to sign a consent form.
For those in the REMAIN group, you will have follow-up visits every 4 to 8 weeks, depending on your usual infliximab schedule. If you're in the STOP group, you'll have visits every 8 weeks. If your sarcoidosis shows signs of coming back (a relapse) within the first year, you'll have additional visits. The study team will explain the exact schedule and what checks, like blood tests, will be done at each visit.
Potential risks and benefits
Locations (1)
- Hôpital de la Pitié-SalpêtrièreVerified postcodeParis, France
Common questions
What is infliximab?
Infliximab is a powerful medicine often used for severe conditions like sarcoidosis to calm down an overactive immune system.
What does 'remission' mean?
Remission means your sarcoidosis is stable, and there are no signs of active disease at that time.
Will I get to choose if I stop or continue infliximab?
No, you will be randomly assigned to either the group that stops or the group that continues infliximab, like flipping a coin.
What if my sarcoidosis gets worse during the study?
The study team will monitor you closely. If your sarcoidosis flares up, they will adjust your treatment or take you out of the study to ensure you receive the best care.
Are there any costs involved for me?
No, participation in the study, including all study-related visits and tests, will be covered and you will not have to pay.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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