Teriflunomide 14 MG ( DrugBank: Teriflunomide )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎6

13. 多発性硬化症/視神経脊髄炎


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
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PhaseCountries
1EUCTR2020-005899-36-IT
(EUCTR)
09/03/202226/11/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Hong Kong;Slovakia;Spain;Guatemala;Chile;Russian Federation;Colombia;Italy;Switzerland;United Kingdom;India;Argentina;Malaysia;China
2NCT04410965
(ClinicalTrials.gov)
May 20, 202028/5/2020Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 WeeksEvaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 WeeksMultiple SclerosisDrug: TERIFLUNOMIDESanofiNULLCompleted18 Years55 YearsAll82Phase 4China
3NCT04129736
(ClinicalTrials.gov)
October 10, 201915/10/2019Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple SclerosisDetermination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.Multiple Sclerosis, PharmacokineticsDrug: Teriflunomide 14 MGJan LyckeNULLCompleted18 Years65 YearsAll12Phase 4Sweden
4EUCTR2016-004414-10-SE
(EUCTR)
23/02/201802/01/2018Determination 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Sweden
5NCT03122652
(ClinicalTrials.gov)
September 25, 201712/4/2017Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated SyndromeMulti-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS StudyMultiple SclerosisDrug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral TabletCentre Hospitalier Universitaire de NiceGenzyme, a Sanofi CompanyCompleted18 YearsN/AAll125Phase 3France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom
6NCT02587195
(ClinicalTrials.gov)
December 18, 201522/9/2015A 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 PeriodA 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 PeriodMultiple SclerosisDrug: TeriflunomideCentre Hospitalier Universitaire de NiceNULLUnknown status18 Years55 YearsAll5Phase 3France