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 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2019-003625-16-HR (EUCTR) | 26/08/2020 | 12/11/2020 | An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis | An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis | Relapsing 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: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603, TGTX1101 | TG Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia | ||
| 2 | EUCTR2017-000639-15-HR (EUCTR) | 19/12/2017 | 13/04/2018 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Serbia;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;Georgia;United Kingdom | ||
| 3 | EUCTR2017-000638-75-PL (EUCTR) | 13/12/2017 | 20/09/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Serbia;Belarus;Spain;Poland;Ukraine;Russian Federation;Georgia;United Kingdom | ||
| 4 | EUCTR2017-000639-15-PL (EUCTR) | 06/12/2017 | 22/09/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Belarus;Spain;Poland;Ukraine;Romania;Croatia;Russian Federation;United Kingdom | ||
| 5 | EUCTR2017-000638-75-ES (EUCTR) | 05/12/2017 | 10/10/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Serbia;Belarus;United States;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom | ||
| 6 | EUCTR2017-000639-15-ES (EUCTR) | 05/12/2017 | 10/10/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Belarus;United States;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom | ||
| 7 | EUCTR2017-000638-75-GB (EUCTR) | 05/12/2017 | 06/09/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Serbia;Belarus;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom | ||
| 8 | EUCTR2017-000639-15-GB (EUCTR) | 04/12/2017 | 06/09/2017 | Ublituximab In Multiple Sclerosis Treatment Effects | Phase III: UbliTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - Ultimate II Study | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ubltuximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom | ||
| 9 | NCT03277261 (ClinicalTrials.gov) | August 1, 2017 | 7/9/2017 | A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) | UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) | Relapsing Multiple Sclerosis (RMS) | Biological: Ublituximab;Drug: Teriflunomide | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 500 | Phase 3 | United States |
| 10 | NCT03277248 (ClinicalTrials.gov) | August 1, 2017 | 7/9/2017 | A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2) | ubLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) | Relapsing Multiple Sclerosis (RMS) | Biological: Ublituximab;Drug: Teriflunomide | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 500 | Phase 3 | United States |