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.
| 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 | NCT03920722 | September 2019 | 29 April 2019 | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis | Microscopic Polyangiitis (MPA) | Drug: Rituximab;Drug: placebo | Assistance Publique - Hôpitaux de Paris | French Vasculitis Study Group | Not recruiting | 18 Years | N/A | All | 106 | Phase 3 | France |
| 2 | EUCTR2018-000637-12-FR | 29/03/2019 | 30 April 2019 | Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis | Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPRO | Patients 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 | 106 | Phase 3 | France | |||
| 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 | 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 | |||
| 7 | 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 |
| 8 | 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 |
| 9 | 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 | |||
| 10 | 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 |
| 11 | NCT02115997 | July 6, 2015 | 22 October 2019 | A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis | Wegener's Granulomatosis or Microscopic Polyangiitis | Drug: Methylprednisolone;Drug: Prednisone;Drug: Rituximab | Hoffmann-La Roche | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | India | ||
| 12 | 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 | ||
| 13 | 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 |
| 14 | 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 | |
| 15 | 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 |
| 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 | JPRN-JapicCTI-132394 | 07/3/2014 | 16 July 2019 | Phase 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 LIMITED | Recruiting | 20 | BOTH | 36 | Phase 3 | Japan | ||
| 17 | JPRN-UMIN000012072 | 2013/12/01 | 2 April 2019 | A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis | Microscopic polyangiitis | Tocilizumab group | Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity | Not Recruiting | 20years-old | 80years-old | Male and Female | 20 | Phase 3 | Japan | ||
| 18 | JPRN-UMIN000011242 | 2013/09/01 | 2 April 2019 | Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitis | Microscopic polyangiitis | tocilizumab monotherapy | Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology | Not Recruiting | 20years-old | 80years-old | Male and Female | 10 | Not selected | Japan | ||
| 19 | JPRN-UMIN000011244 | 2013/09/01 | 2 April 2019 | A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis | Microscopic polyangiitis | Tocilizumab group Cyclophosphamide group | Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology | Not Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan | ||
| 20 | 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 | |
| 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 | 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 |
| 22 | NCT01663623 | March 20, 2013 | 11 June 2018 | Belimumab in Remission of VASculitis | A 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 Polyangiitis | Vasculitis | Biological: Placebo;Biological: Belimumab 10 mg/kg;Drug: Azathioprine | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 106 | Phase 3 | United 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 |
| 23 | 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 | |||
| 24 | 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 | |
| 25 | 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 | |
| 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 | 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 | ||
| 27 | 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 | |
| 28 | NCT00751517 | September 2008 | 19 February 2015 | Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides | Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial. | Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis;Polyarteritis Nodosa | Drug: Methotrexate;Drug: Cyclophosphamide | University of Parma | Not recruiting | 18 Years | 80 Years | Both | Phase 2 | Italy | ||
| 29 | 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 | |
| 30 | NCT00307671 | July 2005 | 19 February 2015 | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis Nodosa | Drug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexate | Assistance Publique - Hôpitaux de Paris | Not recruiting | 65 Years | N/A | Both | 108 | 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 |
| 31 | NCT00104299 | January 2005 | 16 December 2017 | Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis | Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis | Drug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: Prednisone | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN);Genentech, Inc. | Not recruiting | 15 Years | N/A | All | 197 | Phase 2/Phase 3 | United States;Netherlands |
| 32 | NCT00103792 | December 2004 | 19 February 2015 | Mycophenolate 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 Vasculitis | Wegener's Granulomatosis;Vasculitis | Drug: mycophenolate mofetil;Drug: cyclophosphamide | University Medical Centre Groningen | Recruiting | 18 Years | N/A | Both | 90 | Phase 3 | Netherlands | |
| 33 | NCT00307593 | May 2004 | 19 February 2015 | RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides | Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies | Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis | Drug: Infliximab;Drug: Rituximab | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | Both | 20 | N/A | France | |
| 34 | NCT00307645 | May 2003 | 19 February 2015 | IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis | Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis | ANCA Associated Systemic Vasculitis Including Wegener’s;Granulomatosis and Microscopic Polyangiitis and;Renal Limited Vasculitis | Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Prednisone (and methylprednisolone) | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | Both | 160 | Phase 3 | France;United Kingdom | |
| 35 | NCT00753103 | January 2003 | 19 February 2015 | Anti-Cytokine Therapy for Vasculitis | Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis | Wegener's Granulomatosis;Renal Limited Vasculitis;Microscopic Polyangiitis | Biological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: Methylprednisolone | University Hospital Birmingham NHS Foundation Trust | Not recruiting | 18 Years | N/A | Both | 37 | Phase 2 | 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 |
| 36 | NCT00405860 | December 2002 | 19 February 2015 | CellCept in p-ANCA Vasculitis | A Pilot Study of Mycophenolate Mofetil (MMF) in Patients With p-ANCA Microscopic Polyangiitis and Mild to Moderate Renal Dysfunction. | MPO-ANCA Vasculitis;Microscopic Polyangiitis | Drug: CellCept (mycophenolate mofetil) | Mayo Clinic | Roche Pharma AG | Not recruiting | 18 Years | N/A | Both | 18 | Phase 1 | United States |
| 37 | NCT00307658 | March 2001 | 19 February 2015 | Intravenous Immunoglobulin After Relapse in Vasculitis | Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener’s Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial | ANCA + Vasculitides Relapsing Either Under Corticosteroid;and Immunosuppressant Therapies or After One Year;Post Treatment. | Drug: Intravenous immunoglobulins (human immunoglobulins G) | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | Both | 40 | Phase 3 | France | |
| 38 | NCT00430105 | February 1998 | 19 February 2015 | Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides | Randomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated Vasculitides | ANCA Associated Systemic Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis | Drug: cyclophosphamide | Cambridge University Hospitals NHS Foundation Trust | Not recruiting | 18 Years | 80 Years | Both | 160 | Phase 2/Phase 3 | ||
| 39 | NCT00400075 | July 1996 | 19 February 2015 | CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors | CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients | Polyarteritis Nodosa;Microscopic Polyangiitis | Drug: azathioprine;Drug: cyclophosphamide | Hospices Civils de Lyon | Not recruiting | 15 Years | 90 Years | Both | 124 | Phase 4 | Switzerland | |
| 40 | NCT01408836 | March 1995 | 19 February 2015 | Plasma Exchange for Renal Vasculitis | Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis | Wegener's Granulomatosis;Microscopic Polyangiitis | Procedure: Plasma exchange;Drug: Intravenous methyl prednisolone;Drug: Methyl prednisolone | Cambridge University Hospitals NHS Foundation Trust | University Hospital Birmingham;Imperial College London;London North West Healthcare NHS Trust;University Hospitals, Leicester;Lund University Hospital;University Medical Centre Groningen;Fundacio Clinic;Helsinki University | Not recruiting | 18 Years | 80 Years | Both | 150 | Phase 2/Phase 3 | United Kingdom |