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

NCT03704610 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Extrathoracic Sarcoidosis

Interventions

DRUG

Infliximab

An initial period with 2 injections with infliximab allowing the determination of the primary criteria Then an extension with infliximab with 3 supplementary perfusions

DRUG

Placebo

An initial period with 2 injections with placebo allowing the determination of the primary criteria Then an extension with infliximab with 5 supplementary perfusions

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Fleur COHEN AUBART, MCU-PH · APHP - Hôpital Pitié-Salpêtriere, Paris,France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03704610 on ClinicalTrials.gov