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

  
19 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2006-005357-29-BG
(EUCTR)
18/06/200817/04/2008Clinical trial to study a drug in people with kidney disease related to lupusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis
MedDRA version: 15.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Sweden;United Kingdom;Germany;Netherlands;Bulgaria;Spain;Hungary;France;Portugal
2EUCTR2006-005355-16-GB
(EUCTR)
07/05/200816/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
3EUCTR2006-005357-29-GB
(EUCTR)
07/05/200816/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
369 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
4EUCTR2006-005355-16-SE
(EUCTR)
10/04/200821/12/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
5EUCTR2006-005355-16-PL
(EUCTR)
04/04/200803/01/2008A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Phase 3United Kingdom;Sweden;Portugal;France;Hungary;Spain;Poland;Netherlands;Germany
6EUCTR2006-005355-16-DE
(EUCTR)
25/03/200801/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Poland;Sweden
7EUCTR2006-005357-29-PT
(EUCTR)
07/03/200823/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Hungary;Portugal;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden
8EUCTR2006-005355-16-PT
(EUCTR)
07/03/200823/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Hungary;Portugal;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
9EUCTR2006-005357-29-NL
(EUCTR)
22/02/200822/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
369Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden
10EUCTR2006-005355-16-NL
(EUCTR)
22/02/200822/11/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
11NCT00626197
(ClinicalTrials.gov)
February 200820/2/2008A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus ErythematosusLupus Nephritis;Systemic Lupus ErythematosusDrug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted16 YearsN/AAll381Phase 3United States
12EUCTR2006-005357-29-DE
(EUCTR)
31/01/200801/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONGA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Portugal;Hungary;United Kingdom;Germany;Netherlands;Bulgaria;France;Spain;Sweden
13EUCTR2006-005357-29-SE
(EUCTR)
30/01/200821/12/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
14NCT00539838
(ClinicalTrials.gov)
December 19, 20073/10/2007A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: PlaceboGenentech, Inc.Roche Pharma AGTerminated16 YearsN/AAll33Phase 3United States
15EUCTR2006-005355-16-HU
(EUCTR)
21/11/200718/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
16EUCTR2006-005357-29-HU
(EUCTR)
21/11/200718/10/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
17EUCTR2006-005355-16-FR
(EUCTR)
15/11/200728/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
423Phase 3Portugal;France;Hungary;Poland;Spain;Netherlands;Germany;United Kingdom;Sweden
18EUCTR2006-005357-29-FR
(EUCTR)
09/11/200724/08/2007A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis
MedDRA version: 9.1;Level: LLT;Classification code 10025140;Term: Lupus nephritis
Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
19EUCTR2006-005357-29-PL
(EUCTR)
10/01/2008A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus Lupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
369Phase 3Portugal;France;Hungary;Spain;Poland;Bulgaria;Netherlands;Germany;United Kingdom;Sweden