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Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. (MAINEPSAN)

Primary Purpose

Granulomatosis With Polyangitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prednisone 5mg/day extended of 12 additional months
Placebo 5mg/day extended of 12 additionnal months.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Granulomatosis With Polyangitis focused on measuring Vasculitis, GPA, Granulomatosis with Polyangitis, MPA, Microscopic Polyangitis, Systemic anti-neutrophil cytoplasmic antibodies (ANCA), Prednisone, glucocorticoids, Remission Maintenance, Rituximab, Cyclophosphamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of MPA or GPA independently of ANCA status,
  • Patient aged of 18 years or older,
  • Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an inactive disease defined as a BVAS = 0,
  • Patients receiving maintenance infusion of rituximab 500 mg at 6 and 12 months after the start of vasculitis induction
  • Patients receiving 5-10 mg/day of prednisone at screening,
  • Patient able to give written informed consent prior to participation in the study.
  • 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

Exclusion Criteria:

  • Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
  • Patients with vasculitis with active disease defined as a BVAS >0,
  • Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
  • Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
  • Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the all duration of the study,
  • 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,
  • Patients included in other investigational therapeutic study within the previous 3 months,
  • Patients suspected not to be observant to the proposed treatments,
  • Patients who have white blood cell count ≤4,000/mm3,
  • Patients who have platelet count ≤100,000/mm3,
  • Patients who have ALT or AST level greater than 3 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease,
  • Patients unable to give written informed consent prior to participation in the study.
  • Patients with contraindication to use rituximab,

Sites / Locations

  • CHU Amiens-Hôpital NordRecruiting
  • CHU AngersRecruiting
  • Clinique Rhône-Durance
  • Hôpital Jeanne d'Arc
  • Hôpital Avicenne
  • Hôpital La Cavale BlancheRecruiting
  • Hôpital Louis PradelRecruiting
  • CHU de Caen - Cote de NacreRecruiting
  • Hôpital Louis Pasteur
  • CHU EstaingRecruiting
  • CHU Gabriel MontpiedRecruiting
  • CHIC Créteil
  • CHRU François Mitterrand
  • CHRU François Mitterrand
  • CHRU Lille - Hôpital Claude Huriez
  • Centre Hospitalier Croix RousseRecruiting
  • Hôpital Edouard HerriotRecruiting
  • Hôpital Edouard Herriot
  • Hôpital de la Conception
  • Hôpital de la Conception
  • Hôpital La Timone
  • HP Site Belle Isle
  • CHU Nantes - Hôtel DieuRecruiting
  • CHU de Nice - Hôpital Pasteur 2Recruiting
  • Hôpital la Pitié SalpêtrièreRecruiting
  • Hôpital CochinRecruiting
  • Hôpital Européen G. Pompidou
  • Hôpital Saint Louis
  • Hôpital Haut Lévêque
  • Centre Hospitalier Lyon SudRecruiting
  • CH Lyon SudRecruiting
  • CH Lyon SudRecruiting
  • CHU de Poitiers
  • CHRU Rennes - Hôpital SudRecruiting
  • Hôpital Charles NicolleRecruiting
  • CHU Strasbourg
  • CHRU Hautepierre
  • Hopitaux Universaitaire de Strasbourg HopitauxRecruiting
  • Hôpital Foch
  • CHRU Bretonneau
  • CH de TroyesRecruiting
  • CH ValenciennesRecruiting
  • Hôpitaux de Brabois
  • CH Bretagne AtlantiqueRecruiting
  • CH de Verdun

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisone 5mg/day extended of 12 additional months

Placebo 5mg/day extended of 12 additional months

Arm Description

Prednisone 5mg/day will be administered from Day 1 to Month 12

Placebo 5mg/day will be administered from Day 1 to Month 12

Outcomes

Primary Outcome Measures

Relapse-free survival, relapse being defined as BVAS > 0.
rate of relapse-free survival of patients continuing low-dose prednisone treatment until Month 10 VS those who will have prednisone treatment cessation at Month 1, on remission maintenance with Rituximab therapy, after achievement of remission of GPA or MPA, defined as a survival of patients maintaining a BVAS=0 at Month 30, in patient with newly-diagnosed or relapsing GPA or MPA and who will all have received glucocorticoids for 12 months after diagnosis or last flare before inclusion.

Secondary Outcome Measures

Compare the rate of serious adverse events between Inclusion and Month 30 after randomization
Proportion of patients with at least one adverse event between inclusion and Month 30. Percentage of patients with at least one serious adverse event between inclusion and Month 30, corresponding to any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or congenital anomaly/birth defect or any other adverse event considered "medically significant". Number of deaths, whatever the cause at Month 30.
Compare the rate of predefined severe events related to glucocorticoids between inclusion and Month 30 including osteoporotic fracture and weight gain.
Percentage of patients with at least one predefined severe event corresponding to adverse events 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, symptomatic osteonecrosis, psychiatric or mood disorder requiring drug administration, weight gain >10 kg) between inclusion and Month 30 - Weight gain between inclusion and Month 30
To compare the rate of vasculitis relapse at Month 30
Proportion of patients with minor or major vasculitis relapse between inclusion and Month 30 (BVAS >0) and time to first vasculitis relapse
To compare the prednisone use between inclusion and Month 30
Prednisone area under the curve of administrated dose between inclusion and Month 30
To compare variation of the Bone mineral density and markers between inclusion and Month 30
Variation of the Bone mineral density between inclusion and Month 30 - Variation of the Bone markers including C-terminal crosslinked telopeptide of type I collagen (CTX) and serum procollagen type 1 amino-terminal propeptide (P1NP) between inclusion and Month 30
To compare sequelae assessed by BVAS (vasculitis activity) at 30 months
BVAS (vasculitis activity) at 30 months - Variation of BVAS (Vasculitis activity)
To compare sequelae assessed by the Vasculitis Damage Index (VDI) at 30 months
Vasculitis Damage Index at 30 months Variation of VDI,
- To compare sequelae assessed by Combined Damage Assessment Index (CDA) at 30 months
Combined Damage Assessment Index at 30 months Variation of CDA (damage),
- To compare functional disability at Month 30 after randomization (Day 1) in both arms
Variation of HAQ (disability) between inclusion and at Month 30
To compare quality of life at Month 30 after randomization (Day 1) in both arms
- Variation of SF-36 (quality of life) between inclusion and at Month 30
- To compare healthcare resource utilization at Month 30 after randomization (Day 1) in both arms
- Healthcare resource utilization between inclusion and Month 30 being defined as the percentage of patients being hospitalized at least once except only for rituximab infusions

Full Information

First Posted
August 24, 2017
Last Updated
November 20, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03290456
Brief Title
Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
Acronym
MAINEPSAN
Official Title
A Prospective, Multicentric, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
June 4, 2024 (Anticipated)
Study Completion Date
June 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death. Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile . Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated. On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment. In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12 months). The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to withdraw glucocorticoids after 18 months was left to physician's discretion in this study and two thirds of the nonsevere relapses occurred when patients were off prednisone. The trial detailed here is the first prospective trial evaluating the length of glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.
Detailed Description
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death. Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile. Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated. On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment. In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12 months). The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to withdraw glucocorticoids after 18 months was left to physician's discretion in this study and two thirds of the nonsevere relapses occurred when patients were off prednisone. The trial detailed here is the first prospective trial evaluating the length of glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granulomatosis With Polyangitis
Keywords
Vasculitis, GPA, Granulomatosis with Polyangitis, MPA, Microscopic Polyangitis, Systemic anti-neutrophil cytoplasmic antibodies (ANCA), Prednisone, glucocorticoids, Remission Maintenance, Rituximab, Cyclophosphamide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prednisone 5mg/day extended of 12 additional months
Arm Type
Experimental
Arm Description
Prednisone 5mg/day will be administered from Day 1 to Month 12
Arm Title
Placebo 5mg/day extended of 12 additional months
Arm Type
Placebo Comparator
Arm Description
Placebo 5mg/day will be administered from Day 1 to Month 12
Intervention Type
Drug
Intervention Name(s)
Prednisone 5mg/day extended of 12 additional months
Intervention Description
Prednisone 5mg/day orally during 12 Month + 1 mg/week tapering until 0mg.
Intervention Type
Drug
Intervention Name(s)
Placebo 5mg/day extended of 12 additionnal months.
Intervention Description
1mg/week orally tapering Prednisone until Month 1 + Placebo orally 5mg/day until Month 13
Primary Outcome Measure Information:
Title
Relapse-free survival, relapse being defined as BVAS > 0.
Description
rate of relapse-free survival of patients continuing low-dose prednisone treatment until Month 10 VS those who will have prednisone treatment cessation at Month 1, on remission maintenance with Rituximab therapy, after achievement of remission of GPA or MPA, defined as a survival of patients maintaining a BVAS=0 at Month 30, in patient with newly-diagnosed or relapsing GPA or MPA and who will all have received glucocorticoids for 12 months after diagnosis or last flare before inclusion.
Time Frame
from Screening to Month 30.
Secondary Outcome Measure Information:
Title
Compare the rate of serious adverse events between Inclusion and Month 30 after randomization
Description
Proportion of patients with at least one adverse event between inclusion and Month 30. Percentage of patients with at least one serious adverse event between inclusion and Month 30, corresponding to any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or congenital anomaly/birth defect or any other adverse event considered "medically significant". Number of deaths, whatever the cause at Month 30.
Time Frame
from Day 1 to Month 30
Title
Compare the rate of predefined severe events related to glucocorticoids between inclusion and Month 30 including osteoporotic fracture and weight gain.
Description
Percentage of patients with at least one predefined severe event corresponding to adverse events 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, symptomatic osteonecrosis, psychiatric or mood disorder requiring drug administration, weight gain >10 kg) between inclusion and Month 30 - Weight gain between inclusion and Month 30
Time Frame
From Screening to Month 30
Title
To compare the rate of vasculitis relapse at Month 30
Description
Proportion of patients with minor or major vasculitis relapse between inclusion and Month 30 (BVAS >0) and time to first vasculitis relapse
Time Frame
from Day 1 to Month 30
Title
To compare the prednisone use between inclusion and Month 30
Description
Prednisone area under the curve of administrated dose between inclusion and Month 30
Time Frame
from screening to Month 30
Title
To compare variation of the Bone mineral density and markers between inclusion and Month 30
Description
Variation of the Bone mineral density between inclusion and Month 30 - Variation of the Bone markers including C-terminal crosslinked telopeptide of type I collagen (CTX) and serum procollagen type 1 amino-terminal propeptide (P1NP) between inclusion and Month 30
Time Frame
From Screening to Month 30
Title
To compare sequelae assessed by BVAS (vasculitis activity) at 30 months
Description
BVAS (vasculitis activity) at 30 months - Variation of BVAS (Vasculitis activity)
Time Frame
From Screening to Month 30.
Title
To compare sequelae assessed by the Vasculitis Damage Index (VDI) at 30 months
Description
Vasculitis Damage Index at 30 months Variation of VDI,
Time Frame
From screening to Month 30.
Title
- To compare sequelae assessed by Combined Damage Assessment Index (CDA) at 30 months
Description
Combined Damage Assessment Index at 30 months Variation of CDA (damage),
Time Frame
From Screening to Month 30.
Title
- To compare functional disability at Month 30 after randomization (Day 1) in both arms
Description
Variation of HAQ (disability) between inclusion and at Month 30
Time Frame
From Day 1 to Month 30.
Title
To compare quality of life at Month 30 after randomization (Day 1) in both arms
Description
- Variation of SF-36 (quality of life) between inclusion and at Month 30
Time Frame
- From Day 1 to Month 30.
Title
- To compare healthcare resource utilization at Month 30 after randomization (Day 1) in both arms
Description
- Healthcare resource utilization between inclusion and Month 30 being defined as the percentage of patients being hospitalized at least once except only for rituximab infusions
Time Frame
From Day 1 to Month 30.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of MPA or GPA independently of ANCA status, Patient aged of 18 years or older, Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an inactive disease defined as a BVAS = 0, Patients receiving maintenance infusion of rituximab 500 mg at 6 and 12 months after the start of vasculitis induction Patients receiving 5-10 mg/day of prednisone at screening, Patient able to give written informed consent prior to participation in the study. 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 Exclusion Criteria: Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, Patients with vasculitis with active disease defined as a BVAS >0, Patients with acute infections or chronic active infections (including HIV, HBV or HCV), Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the all duration of the study, 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, Patients included in other investigational therapeutic study within the previous 3 months, Patients suspected not to be observant to the proposed treatments, Patients who have white blood cell count ≤4,000/mm3, Patients who have platelet count ≤100,000/mm3, Patients who have ALT or AST level greater than 3 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease, Patients unable to give written informed consent prior to participation in the study. Patients with contraindication to use rituximab,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe LEGA, Pr
Phone
04.78.86.19.79
Email
jean-christophe.lega@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Puéchal, Dr
Phone
01.58.41.32.41
Email
xavier.puechal@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe LEGA, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Hôpital Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean SCHMIDT, MD
Phone
3 22 66 82 30
Ext
+33
Email
jean.schmidt@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Jean SCHMIDT, MD
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian LAVIGNE, MD
Phone
2 41 35 38 24
Ext
+33
Email
chlavigne@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Christian LAVIGNE, MD
Facility Name
Clinique Rhône-Durance
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre GOBERT, MD
Phone
4 32 75 30 59
Ext
+33
Email
pgobert@ch-avignon.fr
First Name & Middle Initial & Last Name & Degree
Pierre GOBERT, MD
Facility Name
Hôpital Jeanne d'Arc
City
Bar-le-Duc
ZIP/Postal Code
55000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe EVON, MD
Phone
3.29.45.88.03
Ext
+33
Email
pevon@pssm.fr
First Name & Middle Initial & Last Name & Degree
Philippe EVON, MD
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin DHOTE, MD
Phone
1 48 95 58 70
Ext
+33
Email
robin.dhote@avc.aphp.fr
First Name & Middle Initial & Last Name & Degree
Robin DHOTE, MD
Facility Name
Hôpital La Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire DE MOREUIL, MD
Phone
2.98.34.73.36
Ext
+33
Email
claire.demoreuil@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Claire DE MOREUIL, MD
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent COTTIN, Pr
Phone
4 72 35 70 72
Ext
+33
Email
vincent.cottin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Vincent COTTIN, Pr
Facility Name
CHU de Caen - Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MARTIN-SILVA, MD
Phone
2 31 06 57 32
Ext
+33
Email
martinsilva.n@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Nicolas MARTIN-SILVA, MD
Facility Name
Hôpital Louis Pasteur
City
Chartres
ZIP/Postal Code
28018
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard DAMADE, MD
Phone
2 37 30 30 30
Ext
+33
Email
rdamade@ch-chartres.fr
First Name & Middle Initial & Last Name & Degree
Richard DAMADE, MD
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc RUIVARD, Pr
Phone
4 73 75 00 85
Ext
+33
Email
mruivard@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Marc RUIVARD, Pr
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier AUMAITRE, Pr
Phone
4 73 75 14 35
Ext
+33
Email
oaumaitre@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Olivier AUMAITRE, Pr
Facility Name
CHIC Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine FROISSART, MD
Phone
1 45 17 54 80
Ext
+33
Email
antoine.froissart@chicreteil.fr
First Name & Middle Initial & Last Name & Degree
Antoine FROISSART, MD
Facility Name
CHRU François Mitterrand
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard BONNOTTE, Pr
Phone
3 80 29 34 32
Ext
+33
Email
bernard.bonnotte@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Bernard BONNOTTE, Pr
Facility Name
CHRU François Mitterrand
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel REBIBOU, Pr
Phone
3 80 29 34 34
Ext
+33
Email
Jean-michel.rebibou@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel REBIBOU, Pr
Facility Name
CHRU Lille - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric HACHULLA, Pr
Phone
3 20 44 92 96
Ext
+33
Email
e-hachulla@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Eric HACHULLA, Pr
Facility Name
Centre Hospitalier Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal SEVE, Pr
Phone
4 26 73 26 36
Ext
+33
Email
pascal.seve@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Pascal SEVE, Pr
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69137
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud HOT, Pr
Phone
4 72 11 75 68
Ext
+33
Email
arnaud.hot@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Arnaud HOT, Pr
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69137
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent JULLIARD, Pr
Phone
4 72 11 02 51
Ext
+33
Email
laurent.juillard@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Laurent JULLIARD, Pr
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles KAPLANSKI, Pr
Phone
4 91 38 35 01
Ext
+33
Email
Gilles.kaplanski@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Gilles KAPLANSKI, Pr
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noémie JOURDE CHICHE, Pr
Phone
4 91 38 30 42
Ext
+33
Email
Noemie.jourde@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Noémie JOURDE CHICHE, Pr
Facility Name
Hôpital La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas SCHLEINITZ, Pr
Phone
4 91 38 87 62
Ext
+33
Email
nicolas.schleinitz@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Nicolas SCHLEINITZ, Pr
Facility Name
HP Site Belle Isle
City
Metz
ZIP/Postal Code
57045
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François MAURIER, MD
Phone
3 57 84 15 01
Ext
+33
Email
francois.maurier@hp-metz.fr
First Name & Middle Initial & Last Name & Degree
François MAURIER, MD
Facility Name
CHU Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine NEEL, MD
Phone
2 40 08 77 65
Ext
+33
Email
antoine.neel@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Antoine NEEL, MD
Facility Name
CHU de Nice - Hôpital Pasteur 2
City
Nice
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie TIEULIE, MD
Phone
4 92 03 54 77
Ext
+33
Email
tieulie.n@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Nathalie TIEULIE, MD
Facility Name
Hôpital la Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice CACOUB, Pr
Phone
1 42 17 80 27
Ext
+33
Email
patrice.cacoub@psl.aphp.fr
First Name & Middle Initial & Last Name & Degree
Patrice CACOUB, Pr
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier PUECHAL, Pr
Phone
1 58 41 29 71
Ext
+33
Email
xavier.puechal@aphp.fr
First Name & Middle Initial & Last Name & Degree
Xavier PUECHAL, Pr
Facility Name
Hôpital Européen G. Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre KARRAS, Pr
Phone
1 56 09 37 60
Ext
+33
Email
alexandre.karras@egp.aphp.fr
First Name & Middle Initial & Last Name & Degree
Alexandre KARRAS, Pr
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred MAHR, Pr
Phone
1 42 49 97 80
Ext
+33
Email
alfred.mahr@sls.aphp.fr
First Name & Middle Initial & Last Name & Degree
Alfred MAHR, Pr
Facility Name
Hôpital Haut Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Pr
Phone
5 57 65 64 83
Ext
+33
Email
jean-francois.viallard@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Pr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe LEGA, Pr
Phone
04.78.86.19.79
Email
jean-christophe.lega@chu-lyon.fr
Facility Name
CH Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde NOUVIER, Pr
Phone
4 72 67 87 01
Ext
+33
Email
mathilde.nouvier@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Mathilde NOUVIER, Pr
Facility Name
CH Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Christophe LEGA, Pr
Phone
4.78.86.19.79
Ext
+33
Email
jean-christophe.lega@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jean Christophe LEGA, Pr
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu PUYADE, MD
Phone
5 49 44 32 76
Ext
+33
Email
mathieu.puyade@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Mathieu PUYADE, MD
Facility Name
CHRU Rennes - Hôpital Sud
City
Rennes
ZIP/Postal Code
35200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas LE GALLOU, MD
Phone
2 99 26 71 28
Ext
+33
Email
Thomas.LE.GALLOU@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Thomas LE GALLOU, MD
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ygal BENHAMOU, MD
Phone
2 32 88 90 14
Ext
+33
Email
ygal.benhamou@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Ygal BENHAMOU, MD
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent POINDRON, MD
Phone
3 69 55 05 21
Ext
+33
Email
vincent.poindron@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Vincent POINDRON, MD
Facility Name
CHRU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques-Eric GOTTENBERG, Pr
Phone
3 88 12 79 54
Ext
+33
Email
jacques-eric.gottenberg@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Jacques-Eric GOTTENBERG, Pr
Facility Name
Hopitaux Universaitaire de Strasbourg Hopitaux
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry KRUMMEL, MD
Phone
3 69 55 13 22
Ext
+33
Email
Thierry.krummel@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Thierry KRUMMEL, MD
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu GROH, MD
Phone
1 46 25 24 16
Ext
+33
Email
je.kahn@hopital-foch.org
First Name & Middle Initial & Last Name & Degree
Mathieu GROH, MD
Facility Name
CHRU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth DIOT, MD
Phone
2 47 47 98 19
Ext
+33
Email
elisabeth.diot@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Elisabeth DIOT, MD
Facility Name
CH de Troyes
City
Troyes
ZIP/Postal Code
10003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale CHAUVEAU-JOUVE, MD
Phone
3 25 49 49 49
Ext
+33
Email
pascale.chauveau-jouve@ch-troyes.fr
First Name & Middle Initial & Last Name & Degree
Pascale CHAUVEAU-JOUVE, MD
Facility Name
CH Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas QUEMENEUR, MD
Phone
3 27 14 30 89
Ext
+33
Email
quemeneur-t@ch-valenciennes.fr
First Name & Middle Initial & Last Name & Degree
Thomas QUEMENEUR, MD
Facility Name
Hôpitaux de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolland JAUSSAUD, MD
Phone
3 83 15 40 60
Ext
+33
Email
r.jaussaud@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Rolland JAUSSAUD, MD
Facility Name
CH Bretagne Atlantique
City
Vannes
ZIP/Postal Code
56017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal GODMER, MD
Phone
2 97 01 41 45
Ext
+33
Email
pascal.godmer@ch-bretagne-atlantique.fr
First Name & Middle Initial & Last Name & Degree
Pascal GODMER, MD
Facility Name
CH de Verdun
City
Verdun
ZIP/Postal Code
55100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assetou DIARRASOUBA, MD
Phone
3 29 83 64 42
Ext
+33
Email
adiarrassouba@ch-verdun.fr
First Name & Middle Initial & Last Name & Degree
Assetou DIARRASOUBA, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.

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