Overview

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

Status:
Active, not recruiting

Trial end date:
2021-09-07

Target enrollment:

Participant gender:

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

Details

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Treatments:

Infliximab