AIN ( DrugBank: - )


1 disease
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16

13. 多発性硬化症/視神経脊髄炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-004019-29-PL
(EUCTR)
07/10/201302/09/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
380Phase 2United States;Portugal;Finland;Spain;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
2EUCTR2012-004019-29-DE
(EUCTR)
19/09/201306/05/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: Secukinumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
3EUCTR2012-004019-29-PT
(EUCTR)
02/08/201303/06/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
4EUCTR2012-004019-29-CZ
(EUCTR)
18/07/201313/05/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
5EUCTR2012-004019-29-IT
(EUCTR)
10/07/201311/01/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebocontrolled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Level: PT;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]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
470Phase 2United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;Canada;Argentina;Poland;Germany;Japan;Sweden
6EUCTR2012-004019-29-SE
(EUCTR)
19/06/201312/04/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
7EUCTR2012-004019-29-FI
(EUCTR)
19/06/201316/05/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
8JPRN-JapicCTI-132178
01/6/2013A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisA Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis Multiple SclerosisIntervention name : AIN457
INN of the intervention : secukinumab
Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose.
Control intervention name : Placebo
Dosage And administration of the control intervention : Matching placebo will be administered intravenously.
Novartis Pharma K.K.NULL1855BOTH380Phase 2NULL
9NCT01874340
(ClinicalTrials.gov)
June 201328/5/2013Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisA Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: AIN457Novartis PharmaceuticalsNULLTerminated18 Years55 YearsAll28Phase 2Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States
10EUCTR2012-004019-29-ES
(EUCTR)
24/05/201324/06/2013Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden
11EUCTR2012-004019-29-BE
(EUCTR)
29/04/201323/10/2012Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosisA Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
380Phase 2Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden
12NCT01433250
(ClinicalTrials.gov)
February 201226/8/2011A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple SclerosisAn Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: AIN457Novartis PharmaceuticalsNULLCompleted18 Years55 YearsAll39Phase 2Czech Republic;Russian Federation;Ukraine
13EUCTR2011-001629-25-CZ
(EUCTR)
10/01/201211/10/2011A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapsesAn open label extension study to evaluate the safety, tolerability and efficacy of AIN457 in patients with relapsing-remitting multiple sclerosis relapsing-remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: rhumAb to IL-17A igG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
40Czech Republic;Ukraine;Russian Federation
14NCT01051817
(ClinicalTrials.gov)
December 200919/1/2010POC-MD MRI-based Trial in Relapsing-remitting Multiple SclerA Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple Sclerosis;RRMSDrug: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll73Phase 2Czech Republic;Russian Federation;Ukraine;Serbia;Sweden
15EUCTR2009-011626-34-SE
(EUCTR)
28/10/200920/07/2009A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88Phase 2Czech Republic;Sweden
16EUCTR2009-011626-34-CZ
(EUCTR)
21/09/200927/07/2009A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 Relapsing-remitting multiple sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88Russian Federation;Czech Republic;Ukraine;Serbia;Sweden