Evaluating the effects of stopping infliximab treatment in sarcoidosis patients
Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
This study is testing whether stopping infliximab treatment helps people with severe sarcoidosis who have been in remission for six months, compared to those who keep taking the medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | Infliximab, prednisone |
| Locations | 1 site (Paris) |
| Trial ID | NCT05689879 on ClinicalTrials.gov |
What this trial studies
This phase 3 clinical trial investigates the impact of withdrawing infliximab, a TNF-alpha antagonist, in patients with severe refractory sarcoidosis who have been in remission for at least six months. The study compares two strategies: one group will continue infliximab treatment (REMAIN), while the other will stop it (STOP). Patients will be monitored through regular follow-up visits to assess relapse rates and overall health outcomes. The goal is to determine whether prolonged infliximab treatment is necessary to maintain remission in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically-proven sarcoidosis in remission for at least six months while on infliximab and low-dose steroids.
Not a fit: Patients who are pregnant, have active infections, or severe comorbidities such as heart failure or liver disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the optimal duration of infliximab treatment, potentially reducing unnecessary medication exposure for patients.
How similar studies have performed: While the use of TNF-alpha antagonists in sarcoidosis has been established, this specific approach to treatment withdrawal is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 another biomedical research (only Category 1 trial according to the french law)
Where this trial is running
Paris
- Hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Fleur COHEN AUBART, PHD
- Email: fleur.cohen@aphp.fr
- Phone: + 33 1 42 17 82 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.