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 125 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 | NCT05414487 (ClinicalTrials.gov) | October 15, 2022 | 6/6/2022 | Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases Effects of OfatumumabTreatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Dem ... | Exploring the Effects of B Cell Depletion With Ofatumumab on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases - a Prospective Observational Study Exploring the Effects of B Cell Depletion With Ofatumumabon Immune Cells and Meningeal Lymphatic Dra ... | Multiple Sclerosis;Neuromyelitis Optica Spectrum Disorder;Demyelinating Diseases of the Central Nervous System Multiple Sclerosis;Neuromyelitis Optica Spectrum Disorder;Demyelinating Diseases of the Central Nerv ... | Drug: Ofatumumab | Tianjin Medical University General Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 34 | China | |
| 2 | NCT05199571 (ClinicalTrials.gov) | July 22, 2022 | 6/1/2022 | Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China | A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Eff ... | Relapsing Multiple Sclerosis | Biological: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 100 | Phase 4 | China |
| 3 | NCT05090371 (ClinicalTrials.gov) | March 2, 2022 | 12/10/2021 | A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation A Multicenter Study of Continued Current Therapy vs Transition to OfatumumabAfter Neurofilament (NfL ... | A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS) A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerab ... | Relapsing-Remitting Multiple Sclerosis | Drug: Ofatumumab;Drug: Disease modifying treatment (DMT) | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 50 Years | All | 150 | Phase 4 | United States;Canada |
| 4 | NCT05171972 (ClinicalTrials.gov) | January 29, 2022 | 10/12/2021 | Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment | Assessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients With Multiple Sclerosis Following Treatment With Ofatumumab Assessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients W ... | Relapsing Remitting Multiple Sclerosis | Drug: Ofatumumab | University of Southern California | Novartis Pharmaceuticals | Recruiting | 18 Years | 65 Years | All | 40 | United States | |
| 5 | NCT05084638 (ClinicalTrials.gov) | January 25, 2022 | 7/10/2021 | Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. Study to Assess the Effect of Ofatumumabin Treatment Naïve, Very Early RRMS Patients Benchmarked Aga ... | AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes. AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab20mg SC Monthly ... | Relapse Remitting Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 35 Years | All | 168 | Phase 4 | United States;Puerto Rico |
| 6 | 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 ofatumumaband siponimod compared 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; ... | ||
| 7 | 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 Ofatumumaband Siponimod Compared 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 ... |
| 8 | 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 ofatumumaband siponimod compared 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; ... | ||
| 9 | 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 ofatumumaband siponimod compared 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 | EUCTR2020-004505-32-IT (EUCTR) | 24/09/2021 | 12/10/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients Study of efficacy and tolerability of ofatumumabvs. First Line disease modifying treatment (DMT) - p ... | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mgSC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS) - STHENOS An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Asses ... | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclero ... | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE Product Name: COPAXONE Product Code: [-] INN or Proposed INN: glatiramer acetato Trade Name: Rebif Product Name: Rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: Rebif Product Name: rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: plegridy Product Name: plegridy Product Code: [-] INN or Proposed INN: peginterferone beta 1a Trade Name: Avonex Product Name: Avonex Product Code: [-] INN or Proposed INN: Interferone beta 1a Trade Name: Extavia Product Name: Extavia Product Code: [-] INN or Proposed INN: interferone beta-1b Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN Trade Name: COPAXONE- 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE Product Name: COPAXONE Pr ... | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;Italy |