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 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2012-004019-29-PL (EUCTR) | 07/10/2013 | 02/09/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | United States;Portugal;Finland;Spain;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 2 | EUCTR2012-004019-29-DE (EUCTR) | 19/09/2013 | 06/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 3 | EUCTR2012-004019-29-PT (EUCTR) | 02/08/2013 | 03/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 4 | EUCTR2012-004019-29-CZ (EUCTR) | 18/07/2013 | 13/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 5 | EUCTR2012-004019-29-IT (EUCTR) | 10/07/2013 | 11/01/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;Canada;Argentina;Poland;Germany;Japan;Sweden | ||
| 6 | EUCTR2012-004019-29-FI (EUCTR) | 19/06/2013 | 16/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 7 | EUCTR2012-004019-29-SE (EUCTR) | 19/06/2013 | 12/04/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 8 | JPRN-JapicCTI-132178 | 01/6/2013 | A 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 | A 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 Sclerosis | Intervention 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. | NULL | 18 | 55 | BOTH | 380 | Phase 2 | NULL | ||
| 9 | NCT01874340 (ClinicalTrials.gov) | June 2013 | 28/5/2013 | Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A 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 Sclerosis | Drug: Placebo;Drug: AIN457 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 28 | Phase 2 | Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States |
| 10 | EUCTR2012-004019-29-ES (EUCTR) | 24/05/2013 | 24/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 11 | EUCTR2012-004019-29-BE (EUCTR) | 29/04/2013 | 23/10/2012 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 12 | EUCTR2011-001629-25-CZ (EUCTR) | 10/01/2012 | 11/10/2011 | A clinical extension study to evaluate the safety, tolerability and efficacy of AIN457 in multiple sclerosis patients with relapses | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Ukraine;Russian Federation |