Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis

• Status: Not yet recruiting
• Trial end date: 2026-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)