Informations générales (source: ClinicalTrials.gov)
Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2023
mars 2027
13 août 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:50:26 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Tenon | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital de la Pitié-Salpêtrière - 75013 - Paris - France | Fleur Dr COHEN-AUBART | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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)