Clinical trial • Phase III • Immunology
INFLIXIMAB for Sarcoidosis
Phase III trial of INFLIXIMAB for Sarcoidosis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Sarcoidosis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 10-09-2024
- First CTIS Authorization Date
- 28-10-2024
Trial design
Randomised, two strategies of remission maintenance (infliximab withdrawal vs continuation) — dosing/schedule not specified in the available documents-controlled Phase III trial across 17 sites in France.
- Randomised
- Yes
- Comparator
- Two strategies of remission maintenance (infliximab withdrawal vs continuation) — dosing/schedule not specified in the available documents
- Target Sample Size
- 90
Eligibility
Recruits 90 Vulnerable population not selected. Adults under legal protection or unable to consent are explicitly excluded ("Adult subject under legal protection or unable ton consent"). Signed informed consent is required from participants; no assent procedures or paediatric consent are applicable because inclusion requires age >= 18 years..
- Pregnancy Exclusion
- Pregnancy or breast-feeding
- Vulnerable Population
- Vulnerable population not selected. Adults under legal protection or unable to consent are explicitly excluded ("Adult subject under legal protection or unable ton consent"). Signed informed consent is required from participants; no assent procedures or paediatric consent are applicable because inclusion requires age >= 18 years.
Inclusion criteria
- {"criterion_text":"- Age superior or equal to 18 years\n- Affiliated to the National French social security system\n- Clinical and radiological presentation consistent with sarcoidosis\n- Presence of non-caseating granulomas in at least one organ\n- Exclusion or other causes of granulomas\n- Infliximab treatment for at least 6 months\n- Steroid dosage < or equal to 10 mg/day for at least 6 months\n- No activity of the disease (ePOST score 0) for at least 6 months\n- Normal ACE and serum calcemia level\n- Signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Pregnancy or breast-feeding\n- Concurrent vaccination with live vaccines during therapy\n- Inability to understand information about protocol\n- Adult subject under legal protection or unable ton consent\n- Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation\n- Concomitant participation to another biomedical research (only Category 1 trial according to the Jardé law)\n- Positive IGRA test without previous antituberculous antibiotherapy\n- Active infection\n- Patients with moderate to severe heart failure (NYHA class III/ IV)\n- Severe liver function disorders (factor V<5%)\n- Alcoholism (>10 drinks/week)\n- Severe kidney function disorders (clearance <20 mL/min)\n- Pre-existing blood dyscrasias\n- History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the percentage of patients with major relapses in the 2 groups","definition_or_measurement_approach":"Percentage of patients with major relapses in the 2 groups"}
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 36
- Consent Approach
- Signed informed consent is required from participants. A subject information sheet and informed consent form document is listed (L1_SIS and ICF). The trial enrolls adults (>=18 years); adults under legal protection or unable to consent are excluded. Languages of consent documents not specified in the available data.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 90
France
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 21-03-2025
- Processing Time Days
- 190
- Number Of Sites
- 17
- Number Of Participants
- 90
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine Interne
- Principal Investigator Name
- Thomas PAPO
- Principal Investigator Email
- thomas.papo@aphp.fr
- Contact Person Name
- Thomas PAPO
- Contact Person Email
- thomas.papo@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumologie
- Principal Investigator Name
- Hilario NUNES
- Principal Investigator Email
- hilario.nunes@aphp.fr
- Contact Person Name
- Hilario NUNES
- Contact Person Email
- hilario.nunes@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine interne
- Principal Investigator Name
- Benjamin TERRIER
- Principal Investigator Email
- benjamin.terrier@aphp.fr
- Contact Person Name
- Benjamin TERRIER
- Contact Person Email
- benjamin.terrier@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Médecine interne
- Principal Investigator Name
- Mikael EBBO
- Principal Investigator Email
- mikael.ebbo@ap-hm.fr
- Contact Person Name
- Mikael EBBO
- Contact Person Email
- mikael.ebbo@ap-hm.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Médecine Interne
- Principal Investigator Name
- Pascal SEVE
- Principal Investigator Email
- pascal.seve@chu-lyon.fr
- Contact Person Name
- Pascal SEVE
- Contact Person Email
- pascal.seve@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Médecine interne
- Principal Investigator Name
- Jean-François VIALLARD
- Principal Investigator Email
- jean-francois.viallard@chu-bordeaux.fr
- Contact Person Name
- Jean-François VIALLARD
- Contact Person Email
- jean-francois.viallard@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine interne
- Principal Investigator Name
- Arsène MEKINIAN
- Principal Investigator Email
- arsene.mekinian@aphp.fr
- Contact Person Name
- Arsène MEKINIAN
- Contact Person Email
- arsene.mekinian@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Médecine interne
- Principal Investigator Name
- Hervé DEVILLIERS
- Principal Investigator Email
- Herve.devillers@chu-dijon.fr
- Contact Person Name
- Hervé DEVILLIERS
- Contact Person Email
- Herve.devillers@chu-dijon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine Interne
- Principal Investigator Name
- Fleur COHEN AUBART
- Principal Investigator Email
- fleur.cohen@aphp.fr
- Contact Person Name
- Fleur COHEN AUBART
- Contact Person Email
- fleur.cohen@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine interne
- Principal Investigator Name
- Matthieu MAHEVAS
- Principal Investigator Email
- matthieu.mahevas@aphp.fr
- Contact Person Name
- Matthieu MAHEVAS
- Contact Person Email
- matthieu.mahevas@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Médecine interne
- Principal Investigator Name
- Gregory PUGNET
- Principal Investigator Email
- pugnet.g@chu-toulouse.fr
- Contact Person Name
- Gregory PUGNET
- Contact Person Email
- pugnet.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Médecine interne
- Principal Investigator Name
- Emmanuel RIBEIRO
- Principal Investigator Email
- emmanuel.ribeiro@chu-bordeaux.fr
- Contact Person Name
- Emmanuel RIBEIRO
- Contact Person Email
- emmanuel.ribeiro@chu-bordeaux.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Médecine interne
- Principal Investigator Name
- Vincent POINDRON
- Principal Investigator Email
- vincent.poindron@chru-strasbourg.fr
- Contact Person Name
- Vincent POINDRON
- Contact Person Email
- vincent.poindron@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Médecine interne
- Principal Investigator Name
- Laurent SAILLER,
- Principal Investigator Email
- sailler.l@chu-toulouse.fr
- Contact Person Name
- Laurent SAILLER,
- Contact Person Email
- sailler.l@chu-toulouse.fr
- Site Name
- Clinique Nephrologique Saint Exupery
- Department Name
- Médecine interne
- Principal Investigator Name
- Martin MICHAUD
- Principal Investigator Email
- Martin.MICHAUD@clinique-saint-exupery.com
- Contact Person Name
- Martin MICHAUD
- Contact Person Email
- Martin.MICHAUD@clinique-saint-exupery.com
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Médecine interne
- Principal Investigator Name
- Ygal BENHAMOU
- Principal Investigator Email
- ygal.behamou@chu-rouen.fr
- Contact Person Name
- Ygal BENHAMOU
- Contact Person Email
- ygal.behamou@chu-rouen.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Médecine interne
- Principal Investigator Name
- Ludovic TREFOND
- Principal Investigator Email
- ltrefond@chu-clermontferrand.fr
- Contact Person Name
- Ludovic TREFOND
- Contact Person Email
- ltrefond@chu-clermontferrand.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- INFLIXIMAB
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Maximum Dose
- 60 mg/kg (maxTotalDoseAmount 60, dose unit mg/kg)
- Investigational Product Name
- AZATHIOPRINE
- Active Substance
- AZATHIOPRINE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Maximum Dose
- 730 mg/kg (maxTotalDoseAmount 730, dose unit mg/kg)
- Investigational Product Name
- METHOTREXATE
- Active Substance
- METHOTREXATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Maximum Dose
- 1300 mg (maxTotalDoseAmount 1300, dose unit mg)
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