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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03704610
Date of registration: 10/10/2018
Prospective Registration: Yes
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES) EFIRTES
Scientific title: Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES STUDY)
Date of first enrolment: March 28, 2019
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03704610
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).  
Phase:  Phase 3
Countries of recruitment
France
Contacts
Name:     Anne Bissery
Address: 
Telephone: 1 42 16 24 32
Email: anne.bissery@aphp.fr
Affiliation: 
Name:     Fleur COHEN AUBART, MCU-PH
Address: 
Telephone: 142178242
Email: fleur.cohen@aphp.fr
Affiliation: 
Name:     Fleur COHEN AUBART, MCU-PH
Address: 
Telephone:
Email:
Affiliation:  APHP - Hôpital Pitié-Salpêtriere, Paris,France
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Extrathoracic Sarcoidosis
Intervention(s)
Drug: Infliximab
Drug: Placebo
Primary Outcome(s)
Percentage of patients [Time Frame: week 6]
Secondary Outcome(s)
Percentage of patients [Time Frame: week 16 for experimental arm ; week 22 for control arm]
Secondary ID(s)
2017-001809-32
P141205J
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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