49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

  
2 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2018-001735-49-GB
(EUCTR)
01/07/201922/01/2019RIvaroxaban for Stroke patients with AntiPhospholipid SyndromeRivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial - RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome Patients with stroke or other ischaemic brain injury who have antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Rivaroxaban
Product Name: Rivaroxaban
INN or Proposed INN: Rivaroxaban
Other descriptive name: Trade Name Xarelto
Trade Name: Warfarin Sodium
Product Name: Warfarin Sodium
INN or Proposed INN: Warfarin sodium
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2;Phase 3United Kingdom
2EUCTR2012-002345-38-GB
(EUCTR)
30/10/201208/10/2012Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without 'lupus' (systemic lupus erythematosus)A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. - Rivaroxaban in Antiphospholipid Syndrome (RAPS) Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE).
MedDRA version: 14.1;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xarelto
Product Name: Rivaroxaban
INN or Proposed INN: Rivaroxaban
Other descriptive name: Trade name Xarelto
Trade Name: The generic name is warfarin and many producers will be involved
Product Name: Warfarin
INN or Proposed INN: Warfarin
University College LondonNULLNot Recruiting Female: yes
Male: yes
156 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom