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


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 198

  
5 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04702256
(ClinicalTrials.gov)
December 9, 202130/11/2020Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMFInduction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMFLupus Nephritis;Systemic Lupus Erythematosus (SLE)Drug: Obinutuzumab administration;Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil;Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramineAssistance Publique - Hôpitaux de ParisRoche Pharma AGRecruiting14 YearsN/AAll196Phase 3France
2NCT04963296
(ClinicalTrials.gov)
October 26, 20217/7/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus ErythematosusA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Obinutuzumab;Drug: Placebo;Drug: Acetaminophen/Paracetamol;Drug: Diphenhydramine hydrochloride;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years75 YearsAll200Phase 3United States;Argentina;France;Italy;Mexico;New Zealand;Peru;Russian Federation;South Africa;Spain;Brazil;Poland;United Kingdom
3EUCTR2020-005760-57-PL
(EUCTR)
25/10/202121/09/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus ErythematosusA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
INN or Proposed INN: OBINUTUZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Australia;Peru;South Africa;New Zealand
4EUCTR2020-005760-57-IT
(EUCTR)
09/09/202112/10/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus ErythematosusA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - ALLEGORY Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Gazyvaro
Product Code: [na]
INN or Proposed INN: OBINUTUZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand
5EUCTR2020-005760-57-ES
(EUCTR)
30/07/202123/06/2021A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus ErythematosusA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
INN or Proposed INN: OBINUTUZUMAB
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand