Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES)

• Status: Active, not recruiting
• Trial end date: 2021-09-07
• Target enrollment: 0
• Participant gender: All

Summary

The present study was designed to assess the efficacy of infliximab in a 2-period study :

• An initial period with comparison of infliximab versus placebo and allowing the determination of the primary criteria

• Then an extension period in which the 2 arms will receive infliximab (in the placebo group : 5 perfusions and in the experimental group 3 supplemental perfusions). Finally, the 2 groups will receive 5 injections of infliximab There is little evidence in the literature of when and how infliximab should be administered in sarcoidosis. We hypothesized, from our personal experience in 30 cases (18 of which were reported in a retrospective trial (14), that infliximab would have a very quick activity. So it appeared reasonable to evaluate the primary criterion at 6 weeks after initiation of the treatment.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• Clinical and radiological presentation confirming sarcoidosis

• Presence of non caseating granuloma in at least one organ

• Presence of at least one extrathoracic localization, including hypercalcemia

• Exclusion of other causes of granuloma

• Presence of serious organ involvement or relapse/apparition of a new localization despite a first-line immunosuppressive drug

• Age superior or equal to 18 years

Exclusion Criteria:

• Pregnancy or breast feeding or women in age of pregnancy without efficient contraception

• Patients with multiple sclerosis

• Patients with prior history of any cancer in the 5 years before inclusion (except for cutaneous basocellular cancers),

• Patients with a history of hypersensitivity to infliximab to other murine proteins, or to any of the excipients

• Patients with untreated tuberculosis or current other severe infections such as sepsis, abscesses, and opportunistic infections• Patients with moderate or severe heart failure (NYHA class III/IV)

• Concurrent vaccination with live vaccines during therapy

• Inability to understand information about the protocol

• Adult subject under legal protection or unable to consent.

• No informed consent

• Absence of affiliation to National French social security system

• Patients with severe renal failure, severe hepatic impairment, hepatocellular insufficiency, chronic respiratory insufficiency, risk of angle closure glaucoma, risk of urinary retention related to urethroprostatic disorders, certain evolving viral diseases (including hepatitis, herpes, varicella, zoster), psychotic states still not controlled by treatment