43. 顕微鏡的多発血管炎 Microscopic polyangiitis Clinical trials / Disease details
臨床試験数 : 87 / 薬物数 : 84 - (DrugBank : 20) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 88
| 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 | 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 |
| 2 | 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 |
| 3 | JPRN-UMIN000012072 | 2013/12/01 | 01/12/2013 | 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 | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Phase 3 | Japan | |
| 4 | JPRN-UMIN000011242 | 2013/09/01 | 01/09/2013 | Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitis | Microscopic polyangiitis | tocilizumab monotherapy | Saitama Medical Center, Saitama Medical UniversityDepartment of Rheumatology and Clinical Immunology | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 10 | Not selected | Japan | |
| 5 | JPRN-UMIN000011244 | 2013/09/01 | 01/09/2013 | 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 UniversityDepartment of Rheumatology and Clinical Immunology | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan |