Sifalimumab ( DrugBank: Sifalimumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス9

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2010-024069-30-BG
(EUCTR)
21/08/201208/08/2012A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Netherlands;Germany
2EUCTR2010-024069-30-DE
(EUCTR)
21/12/201119/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany
3EUCTR2010-024069-30-NL
(EUCTR)
05/08/201104/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.0;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
544Phase 2Hungary;Germany;Netherlands;France;Chile;Italy;South Africa;Brazil;India;United Kingdom;Canada;Peru;Mexico;Argentina;Romania;Spain;Thailand;United States;Philippines;Poland
4EUCTR2010-024069-30-IT
(EUCTR)
05/07/201119/01/2012A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
544Phase 2United States;Philippines;Spain;Thailand;Chile;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Brazil;Peru;Bulgaria;South Africa;Germany;Netherlands
5EUCTR2010-024069-30-ES
(EUCTR)
19/05/201119/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 13.1;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
544Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Netherlands
6EUCTR2010-024069-30-GB
(EUCTR)
18/05/201113/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Romania;Peru;Bulgaria;South Africa;Netherlands;Germany;Brazil;United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland
7NCT01283139
(ClinicalTrials.gov)
March 31, 201120/1/2011A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus ErythematosusA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: PlaceboMedImmune LLCNULLCompleted18 Years75 YearsAll834Phase 2United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;United Kingdom
8NCT00979654
(ClinicalTrials.gov)
August 201017/9/2009A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or MyositisA Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or MyositisSystemic Lupus ErythematosusDrug: SifalimumabMedImmune LLCPPDCompleted18 Years99 YearsAll118Phase 2United States;Brazil;Canada;Chile
9EUCTR2010-024069-30-HU
(EUCTR)
17/05/2011A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune systemA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 14.1;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]
Product Name: Sifalimumab
Product Code: MEDI-545
INN or Proposed INN: sifalimumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany