RECRUITINGPhase 3INTERVENTIONAL

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

Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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. Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

STOP arm

TNF-alpha antagonists withdrawal

Locations (1)

Hôpital de la Pitié-Salpêtrière

Paris, France