Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis (NCT05689879) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis
France32 participantsStarted 2023-03-23
Plain-language summary
In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative. Treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. We hypothesize that a prolonged course of TNF-alpha would be better for maintaining remission in sarcoidosis.
The population consists of histologically-proven adults sarcoidosis patients who were treated with infliximab and are in remission for at least 6 months with less than or equal to 10 milligrams of steroids (prednisone).
The present study is a phase 3, prospective, randomized, parallel groups, comparative, open-labelled 2 arms study superiority trial comparing a STOP to a REMAIN strategy. Patients will be randomized in the 2 groups in a 1:1 ratio.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age superior or equal to 18 years
* Clinical and radiological presentation consistent with sarcoidosis
* Presence of non-caseating granulomas in at least one organ
* Exclusion or other causes of granulomas
* Infliximab treatment for at least 6 months
* Steroid dosage \< or equal to 10 mg/day for at least 6 months
* No activity of the disease (ePOST score 0) for at least 6 months
* Normal ACE (angiotensin converting enzyme) and serum calcemia level
* Signed informed consent
* Affiliated to the National French social security system
* As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity.
Exclusion Criteria:
* Pregnancy or breast-feeding
* Positive IGRA (Interferon Gamma Release Assays) test without previous antituberculous antibiotherapy
* Active infection
* Patients with moderate to severe heart failure (NYHA class III/ IV)
* Severe liver function disorders
* Alcoholism
* Severe kidney function disorders
* Pre-existing blood dyscrasias
* History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)
* Concurrent vaccination with live vaccines during therapy
* Inability to understand information about protocol
* Adult subject under legal protection or unable ton consent
* Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation
* Concomitant participation to anoth…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration