Urbason ( DrugBank: - )

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3 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
13	多発性硬化症／視神経脊髄炎	5
97	潰瘍性大腸炎	1
222	一次性ネフローゼ症候群	1

13. 多発性硬化症／視神経脊髄炎

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臨床試験数 : 3,342 /  薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

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	EUCTR2012-004807-10-DE (EUCTR)	17/07/2013	26/10/2012	Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis	Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis	MS patients who suffer from severe Optic Neuritis without satisfying improvement after treatment with steroids (3-5 days with 1 g daily at least 7 days prior to randomization) and with persisting visual acuity < 0.7, duration of symptoms should be = 4 weeks MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Urbason® solubile forte 1000 mg Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE	University Medical Center Hamburg Eppendorf	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Germany
2	EUCTR2012-001965-34-ES (EUCTR)	07/11/2012	09/08/2012	Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.	Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.	Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Urbason 40 mg Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE	Servicio de Neurología, HU. Germans Trias i Pujol	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Spain
3	EUCTR2009-017490-38-DE (EUCTR)	03/05/2010	01/02/2010	Randomized Treatment Interruption of Natalizumab - RESTORE	Randomized Treatment Interruption of Natalizumab - RESTORE	Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months. MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: TYSABRI Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: COPAXONE Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: AVONEX Trade Name: Urbason Forte INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: URBASON FORTE	Biogen Idec	NULL	Not Recruiting			Female: yes Male: yes	200		Germany;Spain
4	EUCTR2007-000888-15-ES (EUCTR)	19/05/2008	27/02/2008	ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple	ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple	Pacientes afectos de esclerosis múltiple MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: SOLU-MODERIN 1 g INN or Proposed INN: METHYLPREDNISOLONE Trade Name: URBASON 40 mg comprimidos INN or Proposed INN: METHYLPREDNISOLONE	Servicio de Neurología	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
5	EUCTR2005-005592-14-DE (EUCTR)	27/07/2006	12/05/2006	Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision Protect	Double blind, placebo-controlled study to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis (VISION PROTECT) - Vision Protect	Multiple sclerosis (MS) is a chronic disease of the central nervous system.Optic neuritis represents one of the most common and frequently the first clinical manifestation of MS. Optic neuritis is mainly characterized by a subacute loss of vision.	Trade Name: Erypo/Erypo FS Product Name: Erypo/Erypo FS INN or Proposed INN: Epoetin alfa Other descriptive name: Epo Trade Name: Urbason solubile forte 1000mg Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolon-21-hydrogensuccinat, Natriumsalz	IFSgGmbH, Institute for clinical research	NULL	Not Recruiting			Female: yes Male: yes			Germany

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97. 潰瘍性大腸炎

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臨床試験数 : 2,527 /  薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

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	EUCTR2016-001170-15-ES (EUCTR)	19/10/2017	02/08/2017	Intravenous corticosteroids in moderate ulcerative colitis	Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM	Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Urbason INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE	GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Phase 4	Spain

222. 一次性ネフローゼ症候群

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臨床試験数 : 285 /  薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191

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	EUCTR2011-006115-59-IT (EUCTR)	11/06/2012	08/06/2012	A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)	A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011	MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp MedDRA version: 14.1;Level: PT;Classification code 10018372;Term: Glomerulonephritis membranous;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: MABTHERA*EV 1FL 50ML 500MG Trade Name: URBASON*IM EV 1F 250MG+1F 5ML Trade Name: MEDROL*10CPR DIV 4MG Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG	AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy

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