Fingolimob ( DrugBank: - )


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2

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
1EUCTR2020-002700-39-IT
(EUCTR)
15/09/202117/08/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.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-labelextension (NEOS). - NEOS 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]
Product Name: siponimob
Product Code: [BAF312]
INN or Proposed INN: siponimob
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimob
Product Code: [BAF312]
INN or Proposed INN: Siponimob
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: ofatumumab
Product Name: fingolimod
Product Code: [FTY720]
INN or Proposed INN: fingolimob
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Product Name: Siponimob
Product Code: [BAF312]
INN or Proposed INN: Siponimob
NOVARTIS PHARMA SERVICES AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3Portugal;Serbia;United States;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;Belgium;Poland;Croatia;Romania;Germany
2NCT02769689
(ClinicalTrials.gov)
June 12, 201917/3/2016Methylprednisolone During the Switch Between Natalizumab and FingolimodOnce a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)Multiple SclerosisDrug: Methylprednisolone;Drug: Placebo;Drug: natalizumab (NTZ);Drug: fingolimob (FTY)University Hospital, Clermont-FerrandNULLRecruiting18 Years65 YearsAll56Phase 4France