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 43. 顕微鏡的多発血管炎 [臨床試験数:40,薬物数:51(DrugBank:19),標的遺伝子数:13,標的パスウェイ数:79] 

Searched query = "Microscopic polyangiitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03920722September 201929 April 2019Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic PolyangiitisEfficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic PolyangiitisMicroscopic Polyangiitis (MPA)Drug: Rituximab;Drug: placeboAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupNot recruiting18 YearsN/AAll106Phase 3France
2EUCTR2018-000637-12-FR29/03/201930 April 2019Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitisEfficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPROPatients with newly diagnosed or relapsing MPA, without any poor prognosis marker (FFS=0). Stratification will be made according to peripheral nerve involvement.
MedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RIXATHON 500mg
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)Authorised Female: yes
Male: yes
106Phase 3France
3NCT03895801March 22, 20194 November 2019Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)Polyangiitis, Granulomatosis WithDrug: IFX-1;Drug: Placebo-IFX-1;Drug: Glucocorticoid (GC);Drug: Placebo-Glucocorticoid (Placebo-GC)InflaRx GmbHRecruiting18 YearsN/AAll81Phase 2Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Russian Federation;Spain;Sweden;United Kingdom
4EUCTR2018-000768-27-NL10/03/201930 April 2019Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA)Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not yet available
Current Sponsor code: IFX-1 (former code: CaCP29)
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
InflaRx GmbHAuthorised Female: yes
Male: yes
81Phase 2France;Czech Republic;Belgium;Spain;Ireland;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Sweden
5NCT03482479February 4, 201922 October 2019Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaRecruiting18 YearsN/AAll60Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-000768-27-ES17/01/201928 February 2019Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA)Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not yet available
Current Sponsor code: IFX-1 (former code: CaCP29)
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
InflaRx GmbHAuthorised Female: yes
Male: yes
81Phase 2France;Czech Republic;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
7NCT03712345October 15, 20189 September 2019Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)Granulomatosis With Polyangiitis (GPA);Microscopic Polyangiitis (MPA)Drug: IFX-1;Drug: PlaceboInflaRx GmbHIqvia Pty LtdRecruiting18 YearsN/AAll36Phase 2United States;Canada
8JPRN-UMIN0000245742018/07/0221 May 2019Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZMicroscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)TCZ group
Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.


IVCY group
Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.
Tokyo women's medical university Institute of rheumatologyHokkaido university hospital Saitama medical center Tokyo women's medical university hospital Keio university hospital Juntendo university hospital Kyorin university hospital St. Marianna university hospital Okayama university hospital Kagawa university hospital Hospital of the university of occupational and environmental health, Japan Tokyo Medical Center Touhoku University Hospital Kyusyu University Hospital Hiroshima University HospitalRecruiting20years-old85years-oldMale and Female48Phase 2Japan
9EUCTR2016-001121-14-GB06/04/201728 February 2019A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/AzathioprineAnti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
Pharmaceutical Form: Capsule
INN or Proposed INN: Avacopan
CAS Number: 1346623-17-3
Current Sponsor code: CCX168
Other descriptive name: CCX168
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Prednison acis® 5 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Pednisone
CAS Number: 53-03-2
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Prednison acis® 20 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Pednisone
CAS Number: 53-03-2
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
ChemoCentryx, Inc.Authorised Female: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
10EUCTR2016-001121-14-SE13/02/201728 February 2019A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/AzathioprineAnti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1 Level: PT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
Pharmaceutical Form: Capsule
INN or Proposed INN: Avacopan
CAS Number: 1346623-17-3
Current Sponsor code: CCX168
Other descriptive name: CCX168
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Prednison acis® 5 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Prednison acis® 20 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
ChemoCentryx, Inc.Authorised Female: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02115997July 6, 201522 October 2019A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic PolyangitisWegener's Granulomatosis or Microscopic PolyangiitisDrug: Methylprednisolone;Drug: Prednisone;Drug: RituximabHoffmann-La RocheRecruiting18 YearsN/AAll30Phase 4India
12NCT01598857December 201410 August 2015BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisA Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNot recruiting18 YearsN/ABoth0Phase 2
13NCT02198248October 201411 February 2019Low-dose Glucocorticoid Vasculitis Induction StudyLow-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control TrialAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisDrug: Rituximab;Drug: GlucocorticoidsChiba UniversityNational Hospital Organization Chiba East HospitalRecruiting20 YearsN/AAll140Phase 4Japan
14JPRN-UMIN0000124092014/06/262 April 2019An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitisGranulomatosis With Polyangiitis (Wegener's) Microscopic PolyangiitisExperimental: Rituximab Maintenance.
Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper.

Active Comparator: Azathioprine Maintenance.
Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27.
University of Miyazaki HospitalThe European Vasculitis Society Vasculitis Clinical Research ConsortiumNot Recruiting18years-oldNot applicableMale and Female190Phase 3Japan,North America,South America,Australia,Europe
15NCT02169219June 201420 August 2018Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated VasculitisShort-Course Glucocorticoids and Rituximab in ANCA-Associated VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Glucocorticoids;Drug: RituximabMassachusetts General HospitalGenentech, Inc.Not recruiting18 Years85 YearsAll20Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16JPRN-JapicCTI-13239407/3/201416 July 2019Phase 3 study of GGS in patients with microscopic polyangiitis (MPA)Randomized, placebo-controlled, double-blind, parallel-group clinical study of GGS in patients with microscopic polyangiitis (MPA) (Phase 3 study)Microscopic polyangiitis (MPA)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : Placebo (physiological saline)
INN of the control intervention : -
Dosage And administration of the control intervention : Intravenous drip infusion
TEIJIN PHARMA LIMITEDRecruiting20BOTH36Phase 3Japan
17JPRN-UMIN0000120722013/12/012 April 2019A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitisMicroscopic polyangiitisTocilizumab groupDepartment of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical UniversitityNot Recruiting20years-old80years-oldMale and Female20Phase 3Japan
18JPRN-UMIN0000112422013/09/012 April 2019Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitisMicroscopic polyangiitistocilizumab monotherapySaitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical ImmunologyNot Recruiting20years-old80years-oldMale and Female10Not selectedJapan
19JPRN-UMIN0000112442013/09/012 April 2019A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitisMicroscopic polyangiitisTocilizumab group
Cyclophosphamide group
Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical ImmunologyNot Recruiting20years-old80years-oldMale and Female40Not selectedJapan
20NCT01750697May 23, 201310 September 2018A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisA Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisGranulomatosis With PolyangiitisDrug: RituximabHoffmann-La RocheNot recruiting2 Years17 YearsAll25Phase 2Germany;Italy;Serbia;Turkey;United Kingdom;United States;Canada;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01697267April 201325 February 2019Rituximab Vasculitis Maintenance StudyAn International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisBiological: Rituximab;Drug: AzathioprineCambridge University Hospitals NHS Foundation TrustArthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of PennsylvaniaNot recruiting15 YearsN/AAll190Phase 3United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic
22NCT01663623March 20, 201311 June 2018Belimumab in Remission of VASculitisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic PolyangiitisVasculitisBiological: Placebo;Biological: Belimumab 10 mg/kg;Drug: AzathioprineHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll106Phase 3United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Norway;Peru;Poland;Romania;Russian Federation;Spain;Sweden;Switzerland;United Kingdom;Austria;Brazil;Czech Republic;Finland;India
23EUCTR2012-002062-13-GB18/01/201313 June 2016A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitisA Phase IIa, International, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety and Pharmacokinetics of 4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients with Severe Granulomatosis with Polyangiitis (Wegener’s) or Microscopic Polyangiitisgranulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis
MedDRA version: 19.0 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: MabThera®
Product Code: RO0452294/V01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: RO0452294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: MabThera®
Product Code: RO0452294/V02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: RO0452294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes
25Phase 2Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
24NCT01731561November 16, 201211 June 2018Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis IIGranulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited FormsDrug: Rituximab (Arm B);Drug: Rituximab (Arm A)Assistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/AAll166Phase 3France
25NCT01613599June 20, 201220 August 2018An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisProspective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With RituximabGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: RituximabGenentech, Inc.Not recruiting18 YearsN/AAll100Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03919825May 201029 April 2019Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - GlucocorticoidsPlasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial [Glucocorticoids]Granulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA)Drug: Glucocorticoids - Standard Dose;Drug: Glucocorticoids - Reduced DoseUniversity of PennsylvaniaNot recruiting15 YearsN/AAll704Phase 3
27NCT00748644October 200811 June 2018Efficacy Study of Two Treatments in the Remission of VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated VasculitisWegener Granulomatosis;Microscopic PolyangiitisDrug: Rituximab;Drug: AzathioprineAssistance Publique - Hôpitaux de ParisNot recruiting18 Years75 YearsAll117Phase 3France
28NCT00751517September 200819 February 2015Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing VasculitidesCyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis;Polyarteritis NodosaDrug: Methotrexate;Drug: CyclophosphamideUniversity of ParmaNot recruiting18 Years80 YearsBothPhase 2Italy
29NCT00647166May 200819 October 2015Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis FactorsMPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of CorticosteroidsDrug: corticosteroid and azathioprine;Drug: corticosteroid and placeboAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/ABoth114Phase 3France
30NCT00307671July 200519 February 2015Treatment of Necrotizing Vasculitides for Patients Older Than 65 YearsTreatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without ImmunosuppressantsVasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis NodosaDrug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexateAssistance Publique - Hôpitaux de ParisNot recruiting65 YearsN/ABoth108Phase 4France
No.TrialIDDate_
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31NCT00104299January 200516 December 2017Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic PolyangiitisRituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)Vasculitis;Wegener's Granulomatosis;Microscopic PolyangiitisDrug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: PrednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Genentech, Inc.Not recruiting15 YearsN/AAll197Phase 2/Phase 3United States;Netherlands
32NCT00103792December 200419 February 2015Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated VasculitisWegener's Granulomatosis;VasculitisDrug: mycophenolate mofetil;Drug: cyclophosphamideUniversity Medical Centre GroningenRecruiting18 YearsN/ABoth90Phase 3Netherlands
33NCT00307593May 200419 February 2015RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing VasculitidesInfliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant TherapiesWegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic PolyangiitisDrug: Infliximab;Drug: RituximabAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/ABoth20N/AFrance
34NCT00307645May 200319 February 2015IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic VasculitisMycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic VasculitisANCA Associated Systemic Vasculitis Including Wegener’s;Granulomatosis and Microscopic Polyangiitis and;Renal Limited VasculitisDrug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Prednisone (and methylprednisolone)Assistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/ABoth160Phase 3France;United Kingdom
35NCT00753103January 200319 February 2015Anti-Cytokine Therapy for VasculitisPhase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated VasculitisWegener's Granulomatosis;Renal Limited Vasculitis;Microscopic PolyangiitisBiological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: MethylprednisoloneUniversity Hospital Birmingham NHS Foundation TrustNot recruiting18 YearsN/ABoth37Phase 2United Kingdom
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
36NCT00405860December 200219 February 2015CellCept in p-ANCA VasculitisA Pilot Study of Mycophenolate Mofetil (MMF) in Patients With p-ANCA Microscopic Polyangiitis and Mild to Moderate Renal Dysfunction.MPO-ANCA Vasculitis;Microscopic PolyangiitisDrug: CellCept (mycophenolate mofetil)Mayo ClinicRoche Pharma AGNot recruiting18 YearsN/ABoth18Phase 1United States
37NCT00307658March 200119 February 2015Intravenous Immunoglobulin After Relapse in VasculitisIntravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener’s Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective TrialANCA + Vasculitides Relapsing Either Under Corticosteroid;and Immunosuppressant Therapies or After One Year;Post Treatment.Drug: Intravenous immunoglobulins (human immunoglobulins G)Assistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/ABoth40Phase 3France
38NCT00430105February 199819 February 2015Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated VasculitidesRandomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated VasculitidesANCA Associated Systemic Vasculitis;Wegener's Granulomatosis;Microscopic PolyangiitisDrug: cyclophosphamideCambridge University Hospitals NHS Foundation TrustNot recruiting18 Years80 YearsBoth160Phase 2/Phase 3
39NCT00400075July 199619 February 2015CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis FactorsCHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 PatientsPolyarteritis Nodosa;Microscopic PolyangiitisDrug: azathioprine;Drug: cyclophosphamideHospices Civils de LyonNot recruiting15 Years90 YearsBoth124Phase 4Switzerland
40NCT01408836March 199519 February 2015Plasma Exchange for Renal VasculitisRandomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal VasculitisWegener's Granulomatosis;Microscopic PolyangiitisProcedure: Plasma exchange;Drug: Intravenous methyl prednisolone;Drug: Methyl prednisoloneCambridge University Hospitals NHS Foundation TrustUniversity Hospital Birmingham;Imperial College London;London North West Healthcare NHS Trust;University Hospitals, Leicester;Lund University Hospital;University Medical Centre Groningen;Fundacio Clinic;Helsinki UniversityNot recruiting18 Years80 YearsBoth150Phase 2/Phase 3United Kingdom

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