Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis
Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
Assistance Publique - Hôpitaux de Paris
90 participants
Mar 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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 Criteria14
- 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)
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Interventions
TNF-alpha antagonists withdrawal
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05689879