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.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04157348 | October 29, 2019 | 11 November 2019 | A 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 Therapy | Eosinophilic Granulomatous Vasculitis | Biological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to Benralizumab | AstraZeneca | Recruiting | 18 Years | 130 Years | All | 140 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom | |
| 2 | NCT03919435 | March 27, 2019 | 29 April 2019 | TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis | Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis | Granulomatosis With Polyangiitis;Wegener Granulomatosis | Drug: Trimethoprim Sulfamethoxazole | University of Pennsylvania | Recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States | |
| 3 | NCT03895801 | March 22, 2019 | 4 November 2019 | Study 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 With | Drug: IFX-1;Drug: Placebo-IFX-1;Drug: Glucocorticoid (GC);Drug: Placebo-Glucocorticoid (Placebo-GC) | InflaRx GmbH | Recruiting | 18 Years | N/A | All | 81 | Phase 2 | Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Russian Federation;Spain;Sweden;United Kingdom | |
| 4 | EUCTR2018-000768-27-NL | 10/03/2019 | 30 April 2019 | Efficacy 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 GmbH | Authorised | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Belgium;Spain;Ireland;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 5 | NCT03482479 | February 4, 2019 | 22 October 2019 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03967925 | February 1, 2019 | 11 June 2019 | Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS | A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis | ANCA Associated Vasculitis;Granulomatosis With Polyangiitis | Drug: Belimumab | Rachel Jones | GlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of Cambridge | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United Kingdom |
| 7 | EUCTR2018-000768-27-ES | 17/01/2019 | 28 February 2019 | Efficacy 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 GmbH | Authorised | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 8 | NCT03712345 | October 15, 2018 | 9 September 2019 | Safety 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: Placebo | InflaRx GmbH | Iqvia Pty Ltd | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States;Canada |
| 9 | JPRN-UMIN000024574 | 2018/07/02 | 21 May 2019 | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ | Microscopic 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 rheumatology | Hokkaido 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 Hospital | Recruiting | 20years-old | 85years-old | Male and Female | 48 | Phase 2 | Japan |
| 10 | NCT03164473 | March 7, 2018 | 25 February 2019 | Maintenance 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 Trial | Eosinophilic Granulomatosis With Polyangiitis | Drug: Rituximab;Drug: Azathioprine;Drug: Placebo-rituximab;Drug: Placebo-azathioprine | Assistance Publique - Hôpitaux de Paris | French Vasculitis Study Group | Recruiting | 18 Years | N/A | All | 98 | Phase 4 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03430388 | January 31, 2018 | 6 May 2019 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | Not recruiting | 2 Years | 60 Years | All | 600 | N/A | Brazil | |
| 12 | NCT02947945 | September 12, 2017 | 16 December 2017 | Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study | Open-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE Study | Asthma | Drug: Reslizumab | National Jewish Health | TEVA | Recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 13 | NCT03010436 | April 15, 2017 | 16 December 2017 | Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study | The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE | Asthma | Drug: Benralizumab | National Jewish Health | AstraZeneca | Recruiting | 18 Years | 100 Years | All | 10 | Phase 2 | United States |
| 14 | EUCTR2016-001121-14-GB | 06/04/2017 | 28 February 2019 | A 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/Azathioprine | Anti-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 | 300 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 15 | EUCTR2016-001121-14-SE | 13/02/2017 | 28 February 2019 | A 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/Azathioprine | Anti-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 | 300 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02807103 | December 5, 2016 | 8 April 2019 | Rituximab in Eosinophilic Granulomatosis With Polyangiitis | Evaluation 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 | Eosinophilic Granulomatosis With Polyangiitis (EGPA) | Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamide | Assistance Publique - Hôpitaux de Paris | French Vasculitis Study Group (FVSG) | Recruiting | 18 Years | N/A | All | 108 | Phase 3 | France |
| 17 | EUCTR2016-000275-25-FR | 21/03/2016 | 18 April 2016 | Evaluation 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. - REOVAS | Evaluation 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. - REOVAS | Patients 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) | Authorised | Female: yes Male: yes | France | |||||
| 18 | NCT02626845 | December 2015 | 11 June 2018 | Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis | Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis | Granulomatosis With Polyangiitis (Wegener's Granulomatosis) | Drug: Rituximab;Other: Placebo | Hospital for Special Surgery, New York | Genentech, Inc.;Roche Pharma AG | Not recruiting | 18 Years | N/A | All | 3 | Phase 4 | United States |
| 19 | EUCTR2014-003162-25-BE | 06/07/2015 | 28 February 2019 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 | Mepolizumab 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 Ltd | Authorised | Female: yes Male: yes | 115 | Phase 3 | United States;Canada;Belgium;Germany;United Kingdom;Japan | |||
| 20 | NCT02108860 | April 2015 | 13 May 2019 | Abatacept 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 Vasculitis | Drug: Abatacept;Drug: placebo | University of South Florida | The Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 15 Years | N/A | All | 66 | Phase 3 | Canada;Germany;United States;Ireland;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03298061 | March 21, 2015 | 7 October 2019 | Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921 | Mepolizumab 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 Syndrome | Drug: Mepolizumab;Drug: Prednisolone | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 104 | Phase 3 | United States;Belgium;Canada;France;Germany;Japan;United Kingdom | |
| 22 | EUCTR2014-003162-25-GB | 19/03/2015 | 28 February 2019 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 | Mepolizumab 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 Ltd | Authorised | Female: yes Male: yes | 42 | Phase 3 | France;Canada;Belgium;Germany;Japan;United Kingdom | |||
| 23 | EUCTR2014-003162-25-DE | 26/02/2015 | 28 February 2019 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 | Mepolizumab 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 Ltd | Authorised | Female: yes Male: yes | 115 | Phase 3 | France;Canada;Belgium;Germany;United Kingdom;Japan | |||
| 24 | NCT01598857 | December 2014 | 10 August 2015 | BIANCA-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 Vasculitis | A 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 Vasculitis | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | ||
| 25 | NCT02198248 | October 2014 | 11 February 2019 | Low-dose Glucocorticoid Vasculitis Induction Study | Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis | Drug: Rituximab;Drug: Glucocorticoids | Chiba University | National Hospital Organization Chiba East Hospital | Recruiting | 20 Years | N/A | All | 140 | Phase 4 | Japan |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | JPRN-UMIN000012409 | 2014/06/26 | 2 April 2019 | An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis | Granulomatosis With Polyangiitis (Wegener's) Microscopic Polyangiitis | Experimental: 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 Hospital | The European Vasculitis Society Vasculitis Clinical Research Consortium | Not Recruiting | 18years-old | Not applicable | Male and Female | 190 | Phase 3 | Japan,North America,South America,Australia,Europe | |
| 27 | NCT02169219 | June 2014 | 20 August 2018 | Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis | Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Glucocorticoids;Drug: Rituximab | Massachusetts General Hospital | Genentech, Inc. | Not recruiting | 18 Years | 85 Years | All | 20 | Phase 4 | United States |
| 28 | NCT02020889 | February 5, 2014 | 12 February 2018 | A Study to Investigate Mepolizumab in 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 | Churg-Strauss Syndrome | Biological: Mepolizumab;Drug: Placebo | GlaxoSmithKline | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | N/A | All | 136 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Japan;Spain;United Kingdom |
| 29 | NCT01933724 | February 2014 | 22 October 2018 | The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach | The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach | Granulomatosis With Polyangiitis;Wegener Granulomatosis;Vasculitis | Drug: 5 mg prednisone;Drug: 0 mg prednisone | University of South Florida | National 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 Network | Recruiting | 18 Years | N/A | All | 60 | Phase 3 | United States |
| 30 | NCT01940094 | February 2014 | 22 October 2019 | The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach | The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach | Granulomatosis With Polyangiitis | Drug: 5 mg Prednisone;Drug: 0 mg Prednisone | University of Pennsylvania | 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 Network | Recruiting | 18 Years | N/A | All | 159 | Phase 3 | United States;Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2012-004385-17-BE | 22/11/2013 | 30 April 2018 | Study 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 Ltd | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Belgium;Germany;Japan;Italy;United Kingdom | |||
| 32 | NCT01750697 | May 23, 2013 | 10 September 2018 | A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | A 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 Polyangiitis | Granulomatosis With Polyangiitis | Drug: Rituximab | Hoffmann-La Roche | Not recruiting | 2 Years | 17 Years | All | 25 | Phase 2 | Germany;Italy;Serbia;Turkey;United Kingdom;United States;Canada;France | |
| 33 | NCT01697267 | April 2013 | 25 February 2019 | Rituximab Vasculitis Maintenance Study | An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis | Biological: Rituximab;Drug: Azathioprine | Cambridge University Hospitals NHS Foundation Trust | Arthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of Pennsylvania | Not recruiting | 15 Years | N/A | All | 190 | Phase 3 | United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic |
| 34 | EUCTR2012-002062-13-GB | 18/01/2013 | 13 June 2016 | A 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 polyangiitis | A 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 Polyangiitis | granulomatosis 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. | Authorised | Female: yes Male: yes | 25 | Phase 2 | Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom | |||
| 35 | NCT01731561 | November 16, 2012 | 11 June 2018 | Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis | MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II | Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited Forms | Drug: Rituximab (Arm B);Drug: Rituximab (Arm A) | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | All | 166 | Phase 3 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT01613599 | June 20, 2012 | 20 August 2018 | An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Rituximab | Genentech, Inc. | Not recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States | |
| 37 | EUCTR2011-001219-30-CZ | 18/08/2011 | 17 August 2015 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, 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 France | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | ||||
| 38 | NCT03919825 | May 2010 | 29 April 2019 | Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids | Plasma 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 Dose | University of Pennsylvania | Not recruiting | 15 Years | N/A | All | 704 | Phase 3 | ||
| 39 | NCT00748644 | October 2008 | 11 June 2018 | Efficacy Study of Two Treatments in the Remission of Vasculitis | MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis | Wegener Granulomatosis;Microscopic Polyangiitis | Drug: Rituximab;Drug: Azathioprine | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | 75 Years | All | 117 | Phase 3 | France | |
| 40 | NCT00647166 | May 2008 | 19 October 2015 | Association 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 Factors | MPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids | Drug: corticosteroid and azathioprine;Drug: corticosteroid and placebo | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | Both | 114 | Phase 3 | France |