Clinical trial • Phase III • Immunology

PREDNISONE for Granulomatosis with polyangiitis (Wegener's) | Microscopic polyangiitis | ANCA-associated vasculitis

Phase III trial of PREDNISONE for Granulomatosis with polyangiitis (Wegener's) | Microscopic polyangiitis | ANCA-associated vasculitis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Granulomatosis with polyangiitis (Wegener's) | Microscopic polyangiitis | ANCA-associated vasculitis
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
03-05-2024
First CTIS Authorization Date
17-06-2024

Trial design

Randomised, placebo oral tablet (microcrystalline cellulose) matching prednisone; active test product: cortancyl (prednisone) 1 mg tablets to be at 5 mg/day at randomization. both arms on background remission-maintenance therapy (rituximab maintenance per mainritsan/mainritsan3 as applicable).-controlled Phase III trial in France.

Randomised
Yes
Comparator
Placebo oral tablet (MICROCRYSTALLINE CELLULOSE) matching prednisone; active test product: CORTANCYL (prednisone) 1 mg tablets to be at 5 mg/day at randomization. Both arms on background remission-maintenance therapy (rituximab maintenance per MAINRITSAN/MAINRITSAN3 as applicable).
Target Sample Size
146
Trial Duration For Participant
900

Eligibility

Recruits 146 Adults only (inclusion criterion: "Patients aged of 18 years or older"). Informed consent: participants must have been informed and given written informed consent prior to participation; patients unable to give written informed consent are excluded. Patients under judicial protection are excluded. No procedures for assent or pediatric consent are described..

Pregnancy Exclusion
Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the total duration of the study
Vulnerable Population
Adults only (inclusion criterion: "Patients aged of 18 years or older"). Informed consent: participants must have been informed and given written informed consent prior to participation; patients unable to give written informed consent are excluded. Patients under judicial protection are excluded. No procedures for assent or pediatric consent are described.

Inclusion criteria

  • {"criterion_text":"- Patients who has been informed about the study and has given his/her written informed consent prior to participation in the study"}
  • {"criterion_text":"- Patients with newly-diagnosed or relapsing MPA or GPA according to the ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definition, independently of ANCA status"}
  • {"criterion_text":"- Patients aged of 18 years or older,"}
  • {"criterion_text":"- Patients in remission (BVAS=0) for MPA or GPA achieved with rituximab, cyclophosphamide, or methotrexate,"}
  • {"criterion_text":"- Patients who will all have already received glucocorticoids for 12 and 36 months ± 8 weeks after diagnosis or last flare before Day 1 for patients treated according the MAINRITSAN and MAINRITSAN3 protocols, respectively."}
  • {"criterion_text":"- At Inclusion visit day, patient must be between 5 and 10 mg/day prednisone and at randomization visit day (D1), patient must be at 5 mg/day prednisone"}
  • {"criterion_text":"- Patients having received 500 mg low-dose rituximab maintenance infusion at remission achievement, according to the MAINRITSAN and MAINRITSAN3 trials"}

Exclusion criteria

  • {"criterion_text":"- Patients with GPA or MPA if glucocorticoids treatment has been increased > 10 mg/day for vasculitis flare or stopped during maintenance therapy"}
  • {"criterion_text":"- Patients suspected not to be observant to the proposed treatments"}
  • {"criterion_text":"- Patients who have neutrophils cell count ≤1.500 /mm3,"}
  • {"criterion_text":"- Patients who have platelet count ≤100,000/mm3,"}
  • {"criterion_text":"- Patients with severe hypogammaglobulinemia (invasive bacterial or fungal infection with IgG < 5 g/L or IgG < 3 g/L in patients without infection)"}
  • {"criterion_text":"- Patients who have ALT or AST or GGT or PAL level greater than 3 times the upper limit of normal or total bilirubin level greater than 2 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease,"}
  • {"criterion_text":"- Patients unable to give written informed consent prior to study participation."}
  • {"criterion_text":"- Patients under judicial protection,"}
  • {"criterion_text":"- Patient not affiliated to a social security scheme or other social protection scheme,"}
  • {"criterion_text":"- Patients who did not get vaccinated of covid-19 according to national recommendations."}
  • {"criterion_text":"- Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference"}
  • {"criterion_text":"- Patients with vasculitis with active disease defined as a BVAS >0,"}
  • {"criterion_text":"- Patients with acute infections including Sars COVID-19 or chronic active infections (including HIV, HBV or HCV)"}
  • {"criterion_text":"- Patients with active cancer or recent cancer (<5 years) or myelodysplasia, except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment"}
  • {"criterion_text":"- Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the total duration of the study"}
  • {"criterion_text":"- Patients with contraindication to use rituximab"}
  • {"criterion_text":"- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,"}
  • {"criterion_text":"- Patients included in other investigational therapeutic study within the previous 3 months excepted for the PNEUMOVAS trial."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- relapse-free survival at Month 30 (18 months after last rituximab maintenance infusion), relapse being defined as BVAS >0.","definition_or_measurement_approach":"Relapse-free survival assessed at Month 30; relapse defined as BVAS >0."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients with at least one AE between Day 1 and Month 30,","definition_or_measurement_approach":"Proportion of patients experiencing at least one adverse event between Day 1 and Month 30."}
  • {"endpoint_text":"- Percentage of patients with at least one minor or major vasculitis flare (BVAS>0) or one predefined severe event corresponding to AE of grade 3 to 5 of the Common Terminology Criteria, including severe side effect related to glucocorticoids (infection requiring hospitalization or intravenous antibiotics, osteoporotic fracture, diabetes requiring medication, cardiovascular event, osteonecrosis, psychiatric or mood disorder requiring drug administration, weight gain >10 kg), between D1 and M30","definition_or_measurement_approach":"Percentage of patients with at least one minor/major vasculitis flare (BVAS>0) or predefined severe CTCAE grade 3-5 events related to glucocorticoids between Day 1 and Month 30; includes specified event types."}
  • {"endpoint_text":"- Percentage of patients with at least one SAE between Day 1 and Month 30 corresponding to any AE that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity or congenital anomaly/birth defect or any other AE considered \"medically significant\",","definition_or_measurement_approach":"Percentage of patients with at least one SAE between Day 1 and Month 30 using standard SAE definitions (death, life-threatening, hospitalization, persistent/significant disability, congenital anomaly, or medically significant)."}
  • {"endpoint_text":"- Percentage of patients with minor (reappearance or worsening of disease with a BVAS >0, not corresponding to a major relapse but requiring mild treatment intensification) or major vasculitis (occurrence or new onset of potentially organ- or life-threatening disease activity that cannot be treated with an increase of glucocorticoids alone and requires further escalation of treatment) between Day 1 and Month 30 (BVAS >0) and time to first vasculitis relapse,","definition_or_measurement_approach":"Percentage with minor or major vasculitis relapse (BVAS>0) between Day 1 and Month 30 and analysis of time to first vasculitis relapse."}
  • {"endpoint_text":"- Variation of GTI toxicity score between Day 1 and Month 30,","definition_or_measurement_approach":"Change in Glucocorticoid Toxicity Index (GTI) score from Day 1 to Month 30."}
  • {"endpoint_text":"- Prednisone area under the curve of administrated dose between Day 1 and Month 30,","definition_or_measurement_approach":"Prednisone cumulative exposure measured as area under the curve of administered dose between Day 1 and Month 30."}
  • {"endpoint_text":"- Number of deaths, whatever the cause at Month 30,","definition_or_measurement_approach":"All-cause mortality count at Month 30."}
  • {"endpoint_text":"- Variation of the bone mineral density between Day 1 and Month 30,","definition_or_measurement_approach":"Change in bone mineral density from Day 1 to Month 30 (measurement modality not specified in JSON)."}

Recruitment

Planned Sample Size
146
Recruitment Window Months
122
Consent Approach
Study requires written informed consent: "Patients who has been informed about the study and has given his/her written informed consent prior to participation in the study". Patients unable to give written informed consent are excluded. Subject information and informed consent form documents are listed in the registry, but languages and age-specific documents are not specified in the available JSON.

Geography

Total Number Of Sites
52
Total Number Of Participants
146

France

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
589
Number Of Sites
52
Number Of Participants
146

Sites

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
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pôle de Médecine Interne
Principal Investigator Name
Xavier PUECHAL
Principal Investigator Email
xavier.puechal@aphp.fr
Contact Person Name
Xavier PUECHAL
Contact Person Email
xavier.puechal@aphp.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Médecine Interne
Principal Investigator Name
Ygal BENHAMOU
Principal Investigator Email
ygal.benhamou@chu-rouen.fr
Contact Person Name
Ygal BENHAMOU
Contact Person Email
ygal.benhamou@chu-rouen.fr
Site Name
Hospices Civils De Lyon
Department Name
Néphrologie
Principal Investigator Name
Laetitia KOPPE
Principal Investigator Email
laetitia.koppe@chu-lyon.fr
Contact Person Name
Laetitia KOPPE
Contact Person Email
laetitia.koppe@chu-lyon.fr
Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Service Médecine interne Maladies du Sang et Maladies Infectieuses
Principal Investigator Name
Jérémy KERAEN
Principal Investigator Email
jeremy.keraen@ch-cornouaille.fr
Contact Person Name
Jérémy KERAEN
Site Name
Hospices Civils De Lyon
Department Name
Pneumologie
Principal Investigator Name
Vincent COTTIN
Principal Investigator Email
vincent.cottin@chu-lyon.fr
Contact Person Name
Vincent COTTIN
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Néphrologie - Dialyse - Aphérèse
Principal Investigator Name
Jean-Philippe COINDRE
Principal Investigator Email
jpcoindre@ch-lemans.fr
Contact Person Name
Jean-Philippe COINDRE
Contact Person Email
jpcoindre@ch-lemans.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 Regional D'Angers
Department Name
Médecine Interne
Principal Investigator Name
Christian LAVIGNE
Principal Investigator Email
chlavigne@chu-angers.fr
Contact Person Name
Christian LAVIGNE
Contact Person Email
chlavigne@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Rhumatologie
Principal Investigator Name
Nathalie TIEULIE
Principal Investigator Email
tieulie.n@chu-nice.fr
Contact Person Name
Nathalie TIEULIE
Contact Person Email
tieulie.n@chu-nice.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de néphrologie et dialyses
Principal Investigator Name
Jean-Jacques BOFFA
Principal Investigator Email
jean-jacques.boffa@aphp.fr
Contact Person Name
Jean-Jacques BOFFA
Contact Person Email
jean-jacques.boffa@aphp.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service de Néphrologie
Principal Investigator Name
Dimitri TITECA
Principal Investigator Email
titeca.dimitri@chu-amiens.fr
Contact Person Name
Dimitri TITECA
Contact Person Email
titeca.dimitri@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Médecine Interne
Principal Investigator Name
Jean-Philippe MARTELLOSIO
Principal Investigator Email
jean-philippe.martellosio@chu-poitiers.fr
Contact Person Name
Jean-Philippe MARTELLOSIO
Site Name
HP Site Belle Isle
Department Name
Médecine Interne
Principal Investigator Name
Julien CAMPAGNE
Principal Investigator Email
julien.campagne@uneos.fr
Contact Person Name
Julien CAMPAGNE
Contact Person Email
julien.campagne@uneos.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Néphrologie
Principal Investigator Name
Noémie JOURDE CHICHE
Principal Investigator Email
Noemie.jourde@ap-hm.fr
Contact Person Name
Noémie JOURDE CHICHE
Contact Person Email
Noemie.jourde@ap-hm.fr
Site Name
Centre Hospitalier Saint Joseph Saint Luc
Department Name
Médecine Interne
Principal Investigator Name
Laurent PERARD
Principal Investigator Email
lperard@ch-stjoseph-stluc-lyon.fr
Contact Person Name
Laurent PERARD
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Médecine Interne
Principal Investigator Name
Thomas LE GALLOU
Principal Investigator Email
Thomas.LE.GALLOU@chu-rennes.fr
Contact Person Name
Thomas LE GALLOU
Contact Person Email
Thomas.LE.GALLOU@chu-rennes.fr
Site Name
Hospices Civils De Lyon
Department Name
Rhumatologie
Principal Investigator Name
Jean-Christophe LEGA
Principal Investigator Email
jean-christophe.lega@chu-lyon.fr
Contact Person Name
Jean-Christophe LEGA
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine Interne 2
Principal Investigator Name
Patrice CACOUB
Principal Investigator Email
patrice.cacoub@psl.aphp.fr
Contact Person Name
Patrice CACOUB
Contact Person Email
patrice.cacoub@psl.aphp.fr
Site Name
Hospital Foch
Department Name
Médecine Interne
Principal Investigator Name
Mathieu GROH
Principal Investigator Email
m.groh@hopital-foch.org
Contact Person Name
Mathieu GROH
Contact Person Email
m.groh@hopital-foch.org
Site Name
Hopital Saint Joseph
Department Name
Médecine Interne
Principal Investigator Name
Antoine POULET
Principal Investigator Email
apoulet@hopital-saint-joseph.fr
Contact Person Name
Antoine POULET
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
Site Name
Centre Hospitalier De Niort
Department Name
Médecine Interne
Principal Investigator Name
Amandine PERIER
Principal Investigator Email
amandine.perier@ch-niort.fr
Contact Person Name
Amandine PERIER
Contact Person Email
amandine.perier@ch-niort.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Médecine Interne
Principal Investigator Name
Antoine NEEL
Principal Investigator Email
antoine.neel@chu-nantes.fr
Contact Person Name
Antoine NEEL
Contact Person Email
antoine.neel@chu-nantes.fr
Site Name
Centre Hospitalier d'Agen
Department Name
Médecine Interne
Principal Investigator Name
Mélanie RORIZ
Principal Investigator Email
Rorizm@ch-agen-nerac.fr
Contact Person Name
Mélanie RORIZ
Contact Person Email
Rorizm@ch-agen-nerac.fr
Site Name
Centre Hospitalier de Verdun
Department Name
Médecine Interne
Principal Investigator Name
Assetou DIARRASOUBA
Principal Investigator Email
adiarrassouba@ch-verdun.fr
Contact Person Name
Assetou DIARRASOUBA
Contact Person Email
adiarrassouba@ch-verdun.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Médecine Interne
Principal Investigator Name
Marc RUIVARD
Principal Investigator Email
mruivard@chu-clermontferrand.fr
Contact Person Name
Marc RUIVARD
Site Name
Hospices Civils De Lyon
Department Name
Médecine Interne
Principal Investigator Name
Arnaud HOT
Principal Investigator Email
arnaud.hot@chu-lyon.fr
Contact Person Name
Arnaud HOT
Contact Person Email
arnaud.hot@chu-lyon.fr
Site Name
Centre Hospitalier De Valenciennes
Department Name
Médecine Interne
Principal Investigator Name
Thomas QUEMENEUR
Principal Investigator Email
quemeneur-t@ch-valenciennes.fr
Contact Person Name
Thomas QUEMENEUR
Contact Person Email
quemeneur-t@ch-valenciennes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Rhumatologie
Principal Investigator Name
Jacques-Eric GOTTENBERG
Principal Investigator Email
jacques-eric.gottenberg@chru-strasbourg.fr
Contact Person Name
Jacques-Eric GOTTENBERG
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Néphrologie
Principal Investigator Name
Mathieu LEGENDRE
Principal Investigator Email
mathieu.legendre@chu-dijon.fr
Contact Person Name
Mathieu LEGENDRE
Contact Person Email
mathieu.legendre@chu-dijon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Médecine Interne
Principal Investigator Name
Nicolas SCHLEINITZ
Principal Investigator Email
nicolas.schleinitz@ap-hm.fr
Contact Person Name
Nicolas SCHLEINITZ
Contact Person Email
nicolas.schleinitz@ap-hm.fr
Site Name
Centre Hospitalier De Boulogne Sur Mer
Department Name
Service de Néphrologie et Hémodialyse
Principal Investigator Name
Rafik MESBAH
Principal Investigator Email
r.mesbah@ch-boulogne.fr
Contact Person Name
Rafik MESBAH
Contact Person Email
r.mesbah@ch-boulogne.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Néphrologie
Principal Investigator Name
Céline LEBAS
Principal Investigator Email
celine.lebas@chru-lille.fr
Contact Person Name
Céline LEBAS
Contact Person Email
celine.lebas@chru-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine Interne
Principal Investigator Name
Baptiste HERVIER
Principal Investigator Email
baptiste.hervier@aphp.fr
Contact Person Name
Baptiste HERVIER
Contact Person Email
baptiste.hervier@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Médecine Interne
Principal Investigator Name
Eric HACHULLA
Principal Investigator Email
e-hachulla@chru-lille.fr
Contact Person Name
Eric HACHULLA
Contact Person Email
e-hachulla@chru-lille.fr
Site Name
CHRU De Nancy
Department Name
Médecine Interne
Principal Investigator Name
Rolland JAUSSAUD
Principal Investigator Email
r.jaussaud@chru-nancy.fr
Contact Person Name
Rolland JAUSSAUD
Contact Person Email
r.jaussaud@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Néphrologie
Principal Investigator Name
Alexandre KARRAS
Principal Investigator Email
alexandre.karras@egp.aphp.fr
Contact Person Name
Alexandre KARRAS
Contact Person Email
alexandre.karras@egp.aphp.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Médecine Interne
Principal Investigator Name
Marc ANDRE
Principal Investigator Email
mandre@chu-clermontferrand.fr
Contact Person Name
Marc ANDRE
Contact Person Email
mandre@chu-clermontferrand.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Médecine Interne
Principal Investigator Name
Claire DEMOREUIL
Principal Investigator Email
claire.demoreuil@chu-brest.fr
Contact Person Name
Claire DEMOREUIL
Contact Person Email
claire.demoreuil@chu-brest.fr
Site Name
CH St Malo - Hôpital Broussais
Department Name
Service des Maladies Respiratoires et Infectieuses
Principal Investigator Name
Yann BAZIN
Principal Investigator Email
y.bazin@ch-stmalo.fr
Contact Person Name
Yann BAZIN
Contact Person Email
y.bazin@ch-stmalo.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Médecine Interne
Principal Investigator Name
Nicolas MARTIN-SILVA
Principal Investigator Email
martinsilva.n@chu-caen.fr
Contact Person Name
Nicolas MARTIN-SILVA
Contact Person Email
martinsilva.n@chu-caen.fr
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Médecine Interne
Principal Investigator Name
Pascal GODMER
Principal Investigator Email
pascal.godmer@ch-bretagne-atlantique.fr
Contact Person Name
Pascal GODMER
Site Name
Centre Hospitalier De Perpignan
Department Name
médecine Interne
Principal Investigator Name
Rodérau OUTH
Principal Investigator Email
roderau.outh@ch-perpignan.fr
Contact Person Name
Rodérau OUTH
Contact Person Email
roderau.outh@ch-perpignan.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Médecine Interne
Principal Investigator Name
Bernard BONNOTTE
Principal Investigator Email
bernard.bonnotte@chu-dijon.fr
Contact Person Name
Bernard BONNOTTE
Contact Person Email
bernard.bonnotte@chu-dijon.fr
Site Name
Hospices Civils De Lyon
Department Name
Médecine Interne
Principal Investigator Name
Isabelle DURIEU
Principal Investigator Email
isabelle.durieu@chu-lyon.fr
Contact Person Name
Isabelle DURIEU
Contact Person Email
isabelle.durieu@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service Néphrologie et transplantation rénale
Principal Investigator Name
Nizar JOHER
Principal Investigator Email
nizar.joher@aphp.fr
Contact Person Name
Nizar JOHER
Contact Person Email
nizar.joher@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Nephrologie, Dialyse, Soins Internsifs
Principal Investigator Name
Thierry KRUMMEL
Principal Investigator Email
Thierry.krummel@chru-strasbourg
Contact Person Name
Thierry KRUMMEL
Contact Person Email
Thierry.krummel@chru-strasbourg
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine interne
Principal Investigator Name
Mathilde de MENTHON
Principal Investigator Email
mathilde.de-menthon@aphp.fr
Contact Person Name
Mathilde de MENTHON
Contact Person Email
mathilde.de-menthon@aphp.fr
Site Name
Centre Hospitalier Regional D'Angers
Department Name
service de Néphrologie, Dialyse, Transplantation
Principal Investigator Name
Jean François AUGUSTO
Principal Investigator Email
JFaugusto@chu-angers.fr
Contact Person Name
Jean François AUGUSTO
Contact Person Email
JFaugusto@chu-angers.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Médecine Interne
Principal Investigator Name
Jean SCHMIDT
Principal Investigator Email
jean.schmidt@chu-amiens.fr
Contact Person Name
Jean SCHMIDT
Contact Person Email
jean.schmidt@chu-amiens.fr
Site Name
Centre Hospitalier De Troyes
Department Name
Médecine Interne – Maladies Infectieuses
Principal Investigator Name
Pascale CHAUVEAU-JOUVE
Principal Investigator Email
pascale.chauveau-jouve@ch-troyes.fr
Contact Person Name
Pascale CHAUVEAU-JOUVE

Sponsor

Primary sponsor

Full Name
Hospices Civils De Lyon
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
CORTANCYL 1 mg, comprimé
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
Marketing authorisation (marketingAuthNumber: 34009 325 085 5 6, FR)
Starting Dose
5 mg/day at randomization (inclusion: patients must be between 5 and 10 mg/day at inclusion)
Frequency
daily (implied by mg/day)
Maximum Dose
5 mg/day
Investigational Product Name
MICROCRYSTALLINE CELLULOSE (placebo)
Active Substance
MICROCRYSTALLINE CELLULOSE
Modality
Other
Routes Of Administration
ORAL
Route
oral
Starting Dose
Placebo tablet matching prednisone dosing (maxDailyDoseAmount listed as 5 mg equivalent)
Maximum Dose
5 mg equivalent (as per product record maxDailyDoseAmount)
Investigational Product Name
MabThera 500 mg concentrate for solution for infusion
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
intravenous infusion
Authorisation Status
Marketing authorisation (EU/1/98/067/002)
Starting Dose
500 mg infusion (low-dose rituximab maintenance as per MAINRITSAN/MAINRITSAN3 history)
Maximum Dose
500 mg per infusion
Combination Treatment
Yes

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