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 44. 多発血管炎性肉芽腫症 [臨床試験数:40,薬物数:57(DrugBank:22),標的遺伝子数:13,標的パスウェイ数:34] 

Searched query = "Wegener granulomatosis", "Multiple vasculitis granulomatous disease", "Granulomatosis with 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
1NCT04157348October 29, 201911 November 2019A Study to Evaluate if Benralizumab Compared to Mepolizumab May be Beneficial in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA)A Randomized, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care TherapyEosinophilic Granulomatous VasculitisBiological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to BenralizumabAstraZenecaRecruiting18 Years130 YearsAll140Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom
2NCT03919435March 27, 201929 April 2019TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With PolyangiitisTrimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis;Wegener GranulomatosisDrug: Trimethoprim SulfamethoxazoleUniversity of PennsylvaniaRecruiting18 YearsN/AAll30Phase 1/Phase 2United States
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
6NCT03967925February 1, 201911 June 2019Rituximab and Belimumab Combination Therapy in PR3 COMBIVASA Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated VasculitisANCA Associated Vasculitis;Granulomatosis With PolyangiitisDrug: BelimumabRachel JonesGlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of CambridgeRecruiting18 YearsN/AAll30Phase 2United Kingdom
7EUCTR2018-000768-27-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
8NCT03712345October 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
9JPRN-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
10NCT03164473March 7, 201825 February 2019Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.MAINtenance of Remission With RITuximab Versus Azathioprine for Patients With Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Prospective, Randomized, Controlled, Double-blind Study: the MAINRITSEG TrialEosinophilic Granulomatosis With PolyangiitisDrug: Rituximab;Drug: Azathioprine;Drug: Placebo-rituximab;Drug: Placebo-azathioprineAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupRecruiting18 YearsN/AAll98Phase 4France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03430388January 31, 20186 May 2019Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNot recruiting2 Years60 YearsAll600N/ABrazil
12NCT02947945September 12, 201716 December 2017Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) StudyOpen-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE StudyAsthmaDrug: ReslizumabNational Jewish HealthTEVARecruiting18 YearsN/AAll10Phase 2United States
13NCT03010436April 15, 201716 December 2017Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) StudyThe Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITEAsthmaDrug: BenralizumabNational Jewish HealthAstraZenecaRecruiting18 Years100 YearsAll10Phase 2United States
14EUCTR2016-001121-14-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
15EUCTR2016-001121-14-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
16NCT02807103December 5, 20168 April 2019Rituximab in Eosinophilic Granulomatosis With PolyangiitisEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind StudyEosinophilic Granulomatosis With Polyangiitis (EGPA)Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamideAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study Group (FVSG)Recruiting18 YearsN/AAll108Phase 3France
17EUCTR2016-000275-25-FR21/03/201618 April 2016Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVASEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVASPatients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening
MedDRA version: 19.0 Level: PT Classification code 10048594 Term: Allergic granulomatous angiitis System Organ Class: 10021428 - Immune system disorders
Trade Name: RITUXIMAB
Product Name: RITUXIMAB
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 10mg/ml-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: CYCLOPHOSPHAMIDE
Product Name: CYCLOPHOSPHAMIDE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: CYCLOPHOSPHAMIDE
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: MESNA
Product Name: MESNA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mesna
Other descriptive name: MESNA
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 100mg/ml-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)AuthorisedFemale: yes
Male: yes
France
18NCT02626845December 201511 June 2018Rituximab for the Otolaryngologic Manifestations of Granulomatosis With PolyangiitisRituximab for the Otolaryngologic Manifestations of Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis (Wegener's Granulomatosis)Drug: Rituximab;Other: PlaceboHospital for Special Surgery, New YorkGenentech, Inc.;Roche Pharma AGNot recruiting18 YearsN/AAll3Phase 4United States
19EUCTR2014-003162-25-BE06/07/201528 February 2019Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)
MedDRA version: 20.0 Level: LLT Classification code 10018701 Term: Granulomatous disease System Organ Class: 100000004867
MedDRA version: 20.0 Level: LLT Classification code 10014956 Term: Eosinophilic granuloma System Organ Class: 100000004864
MedDRA version: 20.0 Level: LLT Classification code 10072580 Term: Granulomatous polyangiitis System Organ Class: 100000004866
MedDRA version: 20.1 Level: LLT Classification code 10014957 Term: Eosinophilic granulomatous vasculitis System Organ Class: 100000004870
MedDRA version: 20.0 Level: LLT Classification code 10056218 Term: Necrotising granulomatous vasculitis System Organ Class: 100000004866
MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10036023 Term: Polyangiitis System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB-240563 (mepolizumab)
Product Code: SB-240563 (mepolizumab)
Pharmaceutical Form: Injection
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Current Sponsor code: SB-240563
Other descriptive name: MEPOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
GlaxoSmithKline Research LtdAuthorisedFemale: yes
Male: yes
115Phase 3United States;Canada;Belgium;Germany;United Kingdom;Japan
20NCT02108860April 201513 May 2019Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)Granulomatosis With Polyangiitis (Wegener's);Granulomatosis With Polyangiitis;Wegener's Granulomatosis;ANCA-Associated VasculitisDrug: Abatacept;Drug: placeboUniversity of South FloridaThe Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting15 YearsN/AAll66Phase 3Canada;Germany;United States;Ireland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03298061March 21, 20157 October 2019Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)Churg-Strauss SyndromeDrug: Mepolizumab;Drug: PrednisoloneGlaxoSmithKlineNot recruiting18 YearsN/AAll104Phase 3United States;Belgium;Canada;France;Germany;Japan;United Kingdom
22EUCTR2014-003162-25-GB19/03/201528 February 2019Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)
MedDRA version: 20.0 Level: LLT Classification code 10018701 Term: Granulomatous disease System Organ Class: 100000004867
MedDRA version: 20.0 Level: LLT Classification code 10014956 Term: Eosinophilic granuloma System Organ Class: 100000004864
MedDRA version: 20.0 Level: LLT Classification code 10072580 Term: Granulomatous polyangiitis System Organ Class: 100000004866
MedDRA version: 20.1 Level: LLT Classification code 10014957 Term: Eosinophilic granulomatous vasculitis System Organ Class: 100000004870
MedDRA version: 20.0 Level: LLT Classification code 10056218 Term: Necrotising granulomatous vasculitis System Organ Class: 100000004866
MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10036023 Term: Polyangiitis System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB-240563 (mepolizumab)
Product Code: SB-240563 (mepolizumab)
Pharmaceutical Form: Injection
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Current Sponsor code: SB-240563
Other descriptive name: MEPOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
GlaxoSmithKline Research LtdAuthorised Female: yes
Male: yes
42Phase 3France;Canada;Belgium;Germany;Japan;United Kingdom
23EUCTR2014-003162-25-DE26/02/201528 February 2019Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)
MedDRA version: 20.0 Level: LLT Classification code 10018701 Term: Granulomatous disease System Organ Class: 100000004867
MedDRA version: 20.0 Level: LLT Classification code 10072580 Term: Granulomatous polyangiitis System Organ Class: 100000004866
MedDRA version: 20.0 Level: LLT Classification code 10014956 Term: Eosinophilic granuloma System Organ Class: 100000004864
MedDRA version: 20.1 Level: LLT Classification code 10014957 Term: Eosinophilic granulomatous vasculitis System Organ Class: 100000004870
MedDRA version: 20.0 Level: LLT Classification code 10056218 Term: Necrotising granulomatous vasculitis System Organ Class: 100000004866
MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10036023 Term: Polyangiitis System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB-240563 (mepolizumab)
Product Code: SB-240563 (mepolizumab)
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Current Sponsor code: SB-240563
Other descriptive name: MEPOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
GlaxoSmithKline Research LtdAuthorised Female: yes
Male: yes
115Phase 3France;Canada;Belgium;Germany;United Kingdom;Japan
24NCT01598857December 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
25NCT02198248October 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26JPRN-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
27NCT02169219June 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
28NCT02020889February 5, 201412 February 2018A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With PolyangiitisA Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care TherapyChurg-Strauss SyndromeBiological: Mepolizumab;Drug: PlaceboGlaxoSmithKlineNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 YearsN/AAll136Phase 3United States;Belgium;Canada;France;Germany;Italy;Japan;Spain;United Kingdom
29NCT01933724February 201422 October 2018The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric ApproachThe Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric ApproachGranulomatosis With Polyangiitis;Wegener Granulomatosis;VasculitisDrug: 5 mg prednisone;Drug: 0 mg prednisoneUniversity of South FloridaNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS);Rare Diseases Clinical Research NetworkRecruiting18 YearsN/AAll60Phase 3United States
30NCT01940094February 201422 October 2019The Assessment of Prednisone In Remission Trial - Centers of Excellence ApproachThe Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence ApproachGranulomatosis With PolyangiitisDrug: 5 mg Prednisone;Drug: 0 mg PrednisoneUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS);Rare Diseases Clinical Research NetworkRecruiting18 YearsN/AAll159Phase 3United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2012-004385-17-BE22/11/201330 April 2018Study of mepolizumab versus placebo in addition to standard of care for the treatment of Eosinophilic Granulomatosis with Polyangiitis.A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy.Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy.
MedDRA version: 17.1 Level: LLT Classification code 10018701 Term: Granulomatous disease System Organ Class: 100000004867
MedDRA version: 17.1 Level: LLT Classification code 10014956 Term: Eosinophilic granuloma System Organ Class: 100000004864
MedDRA version: 17.1 Level: LLT Classification code 10072580 Term: Granulomatous polyangiitis System Organ Class: 100000004866
MedDRA version: 17.1 Level: LLT Classification code 10014957 Term: Eosinophilic granulomatous vasculitis System Organ Class: 100000004870
MedDRA version: 17.1 Level: LLT Classification code 10056218 Term: Necrotising granulomatous vasculitis System Organ Class: 100000004866
MedDRA version: 17.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
MedDRA version: 17.1 Level: LLT Classification code 10036023 Term: Polyangiitis System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Mepolizumab
Product Code: SB-240563
Pharmaceutical Form: Injection
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Current Sponsor code: SB-240563
Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use
GlaxoSmithKline Research & Development LtdNot RecruitingFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Belgium;Germany;Japan;Italy;United Kingdom
32NCT01750697May 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
33NCT01697267April 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
34EUCTR2012-002062-13-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
35NCT01731561November 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01613599June 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
37EUCTR2011-001219-30-CZ18/08/201117 August 2015Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis)Relapse of Wegener’s Granulomatosis
MedDRA version: 13.1 Level: PT Classification code 10047888 Term: Wegener's granulomatosis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 13.1 Level: LLT Classification code 10047889 Term: Wegeners granulomatosis System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: gusperimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: cyclophosphamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: azathioprine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Nordic Pharma FranceNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
38NCT03919825May 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
39NCT00748644October 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
40NCT00647166May 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

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