13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240

  
19 trials found
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1NCT05199688
(ClinicalTrials.gov)
February 28, 20223/12/2021A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum Disorder;NMOSDDrug: SatralizumabHoffmann-La RocheNULLNot yet recruiting2 Years11 YearsAll8Phase 3United States;Argentina;Italy;Mexico;Ukraine
2EUCTR2021-001088-26-IT
(EUCTR)
21/12/202118/10/2021A Clinical, Imaging and Biomarker Study in Neuromyelitis Optica Spectrum Disorder (NMOSD) with Satralizumab as an InterventionSAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION - SAKURABONSAI Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: satralizumab
Product Code: [RO5333787]
INN or Proposed INN: Satralizumab
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Canada;Turkey;Germany;Italy;Korea, Republic of;India
3EUCTR2020-003413-35-BG
(EUCTR)
16/04/202117/02/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
4JPRN-jRCT2031200333
02/03/202129/01/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optica Spectrum Disorder (NMOSD)Satralizumab: 120 mg SC injection every 4 weeks (Q4W)Hans-Christian von BuedingenNULLNot RecruitingNot applicableNot applicableBoth127Phase 4Italy;Taiwan;United States;Poland;Canada;United Kingdom;Ukraine;Bulgaria;Turkey;Korea;Romania;Georgia;Malaysia;Croatia;Hungary;Spain;Germany;Japan
5NCT04660539
(ClinicalTrials.gov)
March 2, 202124/11/2020A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum DisorderDrug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroidsHoffmann-La RocheNULLActive, not recruiting18 YearsN/AAll127Phase 3United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom
6EUCTR2020-003413-35-IT
(EUCTR)
10/02/202124/05/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) - - Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: [RO5333787]
INN or Proposed INN: SATRALIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of
7EUCTR2020-003413-35-HU
(EUCTR)
05/02/202116/11/2020A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
8EUCTR2020-003413-35-DE
(EUCTR)
03/02/202127/10/2020A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
9EUCTR2020-003413-35-HR
(EUCTR)
11/01/202102/09/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of
10JPRN-JapicCTI-205119
15/10/201920/01/2020A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patientsA compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD)Intervention name : SA237
INN of the intervention : satralizumab
Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Chugai Pharmaceutical Co., Ltd.F. Hoffmann-La Roche Ltdcomplete1274BOTH30NAJapan
11EUCTR2015-005431-41-PL
(EUCTR)
16/10/201707/04/2016A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
12EUCTR2015-005431-41-HR
(EUCTR)
30/11/201615/12/2016A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
12Phase 3United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
13EUCTR2013-003752-21-PL
(EUCTR)
31/08/201404/07/2014A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng /SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom
14NCT02073279
(ClinicalTrials.gov)
August 5, 201425/2/2014Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)Drug: Satralizumab;Drug: PlaceboHoffmann-La RocheChugai PharmaceuticalActive, not recruiting18 Years74 YearsAll95Phase 3United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore
15EUCTR2013-003752-21-DE
(EUCTR)
22/05/201420/12/2013A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom
16EUCTR2013-003752-21-GB
(EUCTR)
19/05/201415/10/2013A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom
17JPRN-JapicCTI-132397
20/2/201426/12/2013Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSDA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)Intervention name : SA237
INN of the intervention : satralizumab
Dosage And administration of the intervention : subcutaneous administration of SA237
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Chugai Pharmaceutical Co., Ltd.F. Hoffmann-La Roche Ltdcomplete1274BOTH85Phase 3Japan, Asia except Japan, North America, Europe
18NCT02028884
(ClinicalTrials.gov)
February 20, 20146/1/2014Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)Drug: Satralizumab;Drug: Placebo;Drug: Baseline TreatmentHoffmann-La RocheChugai PharmaceuticalActive, not recruiting12 Years74 YearsAll83Phase 3United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom
19EUCTR2020-003413-35-PL
(EUCTR)
01/03/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of