drugset / Trial / NCT03704610

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

NCT03704610

Phase 3 Completed 31 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2019-03-28
Primary completion
2021-06-21
Completion
2021-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg

Indications