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
Showing 1 to 10 of 47 diseases
| 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 | EUCTR2020-002700-39-HR (EUCTR) | 29/11/2021 | 06/12/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumab and siponimodcompared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation; ... | ||
| 2 | EUCTR2020-005947-22-IT (EUCTR) | 17/11/2021 | 12/10/2021 | Effect of siponimod on progressive multiple sclerosis | Effect of siponimod on relevant imaging and immunological hallmarks of progressive multiple sclerosis - Effect of siponimod on progressive multiple sclerosis Effect of siponimodon relevant imaging and immunological hallmarks of progressive multiple sclerosis ... | Active progressive MS course after an initial relapse clinical course MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Active progressive MS course after an initial relapse clinical course MedDRA version: 21.1;Level: PT ... | Product Name: Siponimod 2 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod Product Name: Siponimod 0,25 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod Product Name: Siponimod 1 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod Product Name: Siponimod2 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod Product Name: Sipo ... | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 3 | NCT04926818 (ClinicalTrials.gov) | October 5, 2021 | 14/6/2021 | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis Efficacy and Safety of Ofatumumab and SiponimodCompared to Fingolimod in Pediatric Patients With Mul ... | A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of ... | Multiple Sclerosis (MS) | Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimod placebo;Other: Siponimod placebo;Other: Ofatumumab placebo Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimodplacebo;Other: Siponimodplacebo;O ... | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 17 Years | All | 180 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Croatia;Estonia;France;Germany;Guatemala;India;Israel;Italy;Latvia;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Taiwan;Turkey United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Croatia;Estonia;France;Germany;Guatemala ... |
| 4 | EUCTR2020-002700-39-SK (EUCTR) | 04/10/2021 | 16/06/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumab and siponimodcompared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation; ... | ||
| 5 | EUCTR2020-002700-39-PL (EUCTR) | 29/09/2021 | 10/08/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumab and siponimodcompared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile; ... | ||
| 6 | NCT04925557 (ClinicalTrials.gov) | September 27, 2021 | 24/5/2021 | Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis | Open-label, Single-blind, Observational, Comparative, Prospective, 36-month, Longitudinal, Controlled Study to Assess Efficacy of Siponimod (Mayzent®) on Microglia in Patients With Active Secondary Progressive Forms of Multiple Sclerosis Open-label, Single-blind, Observational, Comparative, Prospective, 36-month, Longitudinal, Controlle ... | Secondary-progressive Multiple Sclerosis | Drug: Mayzent;Drug: Ocrevus | State University of New York at Buffalo | NULL | Recruiting | 18 Years | 60 Years | All | 60 | Phase 4 | United States |
| 7 | NCT05688436 (ClinicalTrials.gov) | September 24, 2021 | 9/1/2023 | A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate | Pregnancy Outcomes in Women Exposed to Diroximel Fumarate | Multiple Sclerosis | Drug: Diroximel Fumarate;Biological: Alemtuzumab;Drug: Fingolimod;Drug: Glatiramer acetate;Biological: Interferon beta;Biological: Natalizumab;Biological: Ocrelizumab;Biological: Peginterferon beta-1a;Drug: Siponimod Drug: Diroximel Fumarate;Biological: Alemtuzumab;Drug: Fingolimod;Drug: Glatirameracetate;Biological ... | Biogen | NULL | Recruiting | 18 Years | 49 Years | Female | 825 | United States | |
| 8 | EUCTR2020-002700-39-IT (EUCTR) | 15/09/2021 | 17/08/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumab and siponimodcompared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-labelextension (NEOS). - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Product Name: siponimob Product Code: [BAF312] INN or Proposed INN: siponimob Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimob Product Code: [BAF312] INN or Proposed INN: Siponimob Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: ofatumumab Product Name: fingolimod Product Code: [FTY720] INN or Proposed INN: fingolimob Other descriptive name: FINGOLIMOD HYDROCHLORIDE Product Name: Siponimob Product Code: [BAF312] INN or Proposed INN: Siponimob Product Name: siponimob Product Code: [BAF312] INN or Proposed INN: siponimob Other descriptive name: S ... | NOVARTIS PHARMA SERVICES AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile; ... | ||
| 9 | EUCTR2020-002700-39-DE (EUCTR) | 10/09/2021 | 20/05/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumab and siponimodcompared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile; ... | ||
| 10 | EUCTR2020-002700-39-LV (EUCTR) | 09/09/2021 | 28/07/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. Efficacy and safety of ofatumumab and siponimodcompared to fingolimod in pediatric patients with mul ... | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ... | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245 ... | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent Product Code: BAF312 INN or Proposed INN: Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 3 | Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile; ... |