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 |
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1 | EUCTR2020-004505-32-DE (EUCTR) | 06/07/2021 | 25/05/2021 | 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 | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS | 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] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: Glatiramer acetate INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Product Name: Glatiramer acetate INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Product Name: Interferon ß-1b INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;United Kingdom;Italy | ||
2 | EUCTR2020-004505-32-FR (EUCTR) | 09/06/2021 | 26/04/2021 | 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 | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS | 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] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Product Name: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Product Name: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Product Name: Interferon ß-1b Other descriptive name: INTERFERON BETA-1B Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a Product Name: Interferon ß-1a INN or Proposed INN: Interferon beta-1a | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Germany | ||
3 | NCT01158183 (ClinicalTrials.gov) | July 2007 | 7/7/2010 | Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis | Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: BAY86-5046_Interferon-beta-1b | Bayer | NULL | Completed | 18 Years | 65 Years | Both | 226 | N/A | United States |
4 | NCT00270816 (ClinicalTrials.gov) | November 2005 | 27/12/2005 | Interferon ß-1b Treatment by Cyclical Administration | Effect of Cyclical Administration of Interferon ß-1b in Multiple Sclerosis - Comparison With Normal Dose. | Multiple Sclerosis | Drug: Interferon-ß-1b;Drug: Interferon ß-1b | S. Andrea Hospital | Italian Multiple Sclerosis Foundation | Completed | 18 Years | 55 Years | All | 60 | Phase 2/Phase 3 | Italy |