44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 92 / 薬物数 : 106 - (DrugBank : 27) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 78
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-000679-35-FR (EUCTR) | 07/09/2021 | 25/06/2021 | SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” | SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” - SATELITE | Granulomatosis with Polyangiitis;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Trade Name: ORENCIA INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Mycophénolate mofétil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Azathioprine Other descriptive name: AZATHIOPRINE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | France | ||
| 2 | JPRN-UMIN000024574 | 2018/07/02 | 01/05/2017 | 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 universityInstitute of rheumatology | Hokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University Hospital | Recruiting | 20years-old | 85years-old | Male and Female | 48 | Phase 2 | Japan |
| 3 | JPRN-JMA-IIA00325 | 01/07/2018 | 23/01/2018 | 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 | Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA) | Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen: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. . Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen: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 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.. | Masayoshi Harigai | NULL | Pending | >=20 YEARS | <80 YEARS | BOTH | 48 | Phase 2 | Japan |
| 4 | NCT03164473 (ClinicalTrials.gov) | March 7, 2018 | 22/5/2017 | 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 |
| 5 | JPRN-UMIN000012409 | 2014/06/26 | 04/12/2013 | An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis | An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM | 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 SocietyVasculitis Clinical Research Consortium | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 190 | Phase 3 | Japan,North America,South America,Australia,Europe |
| 6 | NCT01697267 (ClinicalTrials.gov) | April 2013 | 31/8/2012 | 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 | Completed | 15 Years | N/A | All | 188 | Phase 3 | United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic |
| 7 | EUCTR2011-001219-30-DE (EUCTR) | 17/01/2012 | 20/06/2011 | 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: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;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 INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 8 | EUCTR2011-001219-30-GB (EUCTR) | 08/11/2011 | 12/07/2011 | 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: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;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 INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 9 | NCT01446211 (ClinicalTrials.gov) | November 2011 | 20/9/2011 | Clinical Study Comparing the New Immunosuppressive 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) | Wegeners Granulomatosis | Drug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids | Nordic Pharma SAS | NULL | Terminated | 18 Years | 75 Years | Both | 4 | Phase 3 | Czech Republic |
| 10 | EUCTR2011-001219-30-ES (EUCTR) | 14/10/2011 | 04/07/2011 | 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: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;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 INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | United Kingdom;Slovakia;Russian Federation;Germany;Czech Republic;Netherlands;France;Spain;Italy;United States;Sweden | |||
| 11 | EUCTR2011-001219-30-SK (EUCTR) | 28/09/2011 | 05/10/2011 | 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: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;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 INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 12 | EUCTR2011-001219-30-SE (EUCTR) | 31/08/2011 | 21/06/2011 | 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 INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 13 | EUCTR2011-001219-30-CZ (EUCTR) | 18/08/2011 | 20/06/2011 | 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 INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 14 | NCT00748644 (ClinicalTrials.gov) | October 2008 | 5/9/2008 | 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 | NULL | Completed | 18 Years | 75 Years | All | 117 | Phase 3 | France |
| 15 | NCT00647166 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | 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 | NULL | Completed | 18 Years | N/A | Both | 114 | Phase 3 | France |