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 | JPRN-jRCT2071220034 | 02/08/2022 | 03/08/2022 | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib - Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib. | Relapsing Multiple Sclerosis | Core Part -Remibrutinib(LOU064) tablet and matching placebo of teriflunomide capsule -Teriflunomide capsule and matching placebo LOU064 tablet Extension part LOU064 tablet | Yamada Hiroyuki | NULL | Recruiting | >= 18age old | <= 55age old | Both | 30 | Phase 3 | US;Italy;Portugal;South Africa;France;Poland;Slovakia;Slovenia;Spain;Sweden;Turkey;Japan |
| 2 | EUCTR2020-005929-89-GR (EUCTR) | 17/06/2022 | 16/12/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extendedtreatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 3 | EUCTR2020-005899-36-LV (EUCTR) | 01/06/2022 | 05/04/2022 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;United States;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany | ||
| 4 | EUCTR2020-005929-89-PL (EUCTR) | 26/04/2022 | 11/03/2022 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study,comparing the efficacy and safety of remibrutinib versus teriflunomide inparticipants with relapsing multiple sclerosis, followed by extendedtreatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 5 | EUCTR2020-005899-36-HR (EUCTR) | 15/04/2022 | 04/05/2022 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany | ||
| 6 | EUCTR2020-005929-89-HR (EUCTR) | 15/04/2022 | 04/05/2022 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 7 | EUCTR2020-005929-89-SI (EUCTR) | 04/04/2022 | 04/01/2022 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 8 | EUCTR2020-005899-36-IT (EUCTR) | 09/03/2022 | 26/11/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib - - | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: [L04AA31] INN or Proposed INN: Teriflunomide Product Name: remibrutinib Product Code: [LOU064C1] INN or Proposed INN: Remibrutinib Other descriptive name: LOU064C1 Product Name: colestiramina Product Code: [-] INN or Proposed INN: COLESTIRAMINA Product Name: Carbone vegetale polvere Product Code: [-] INN or Proposed INN: CARBONE VEGETALE | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Hong Kong;Slovakia;Spain;Guatemala;Chile;Russian Federation;Colombia;Italy;Switzerland;United Kingdom;India;Argentina;Malaysia;China | ||
| 9 | EUCTR2020-005899-36-SK (EUCTR) | 21/02/2022 | 22/11/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 10 | EUCTR2020-005929-89-ES (EUCTR) | 11/02/2022 | 22/12/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study,comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 11 | EUCTR2020-005899-36-ES (EUCTR) | 11/02/2022 | 29/12/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Farmacéutica S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Slovakia;Spain | ||
| 12 | EUCTR2020-005929-89-SE (EUCTR) | 01/02/2022 | 09/11/2021 | Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib | A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: remibrutinib Product Code: LOU064 INN or Proposed INN: Remibrutinib Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: Teriflunomide | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Germany;Sweden |