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 : 21 - 標的パスウェイ数 : 77

  
4 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2021-000679-35-FR
(EUCTR)
07/09/202125/06/2021SATELITE 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France
2NCT04871191
(ClinicalTrials.gov)
September 202126/2/2021Study of Salvage Therapy to Treat Patients With Granulomatosis With PolyangiitisSalvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis;Anti-neutrophil Cytoplasmic Antibody-associated VasculitisDrug: Rituximab;Drug: Tocilizumab;Drug: AbataceptAssistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinNot yet recruiting18 YearsN/AAll42Phase 2France
3JPRN-UMIN000024574
2018/07/0201/05/2017Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical 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 rheumatologyHokkaido 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 HospitalRecruiting20years-old85years-oldMale and Female48Phase 2Japan
4JPRN-JMA-IIA00325
01/07/201823/01/2018Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical 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 HarigaiNULLPending>=20 YEARS<80 YEARSBOTH48Phase 2Japan