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 | EUCTR2020-005899-36-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 | ||
2 | NCT04410965 (ClinicalTrials.gov) | May 20, 2020 | 28/5/2020 | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Multiple Sclerosis | Drug: TERIFLUNOMIDE | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 82 | Phase 4 | China |
3 | NCT04129736 (ClinicalTrials.gov) | October 10, 2019 | 15/10/2019 | Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis | Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily. | Multiple Sclerosis, Pharmacokinetics | Drug: Teriflunomide 14 MG | Jan Lycke | NULL | Completed | 18 Years | 65 Years | All | 12 | Phase 4 | Sweden |
4 | EUCTR2016-004414-10-SE (EUCTR) | 23/02/2018 | 02/01/2018 | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | MS Centrum, Department of Neurology, Sshlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Sweden | ||
5 | NCT03122652 (ClinicalTrials.gov) | September 25, 2017 | 12/4/2017 | Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome | Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study | Multiple Sclerosis | Drug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral Tablet | Centre Hospitalier Universitaire de Nice | Genzyme, a Sanofi Company | Completed | 18 Years | N/A | All | 125 | Phase 3 | France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom |
6 | NCT02587195 (ClinicalTrials.gov) | December 18, 2015 | 22/9/2015 | A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | Multiple Sclerosis | Drug: Teriflunomide | Centre Hospitalier Universitaire de Nice | NULL | Unknown status | 18 Years | 55 Years | All | 5 | Phase 3 | France |