Infliximab (Remicade) ( DrugBank: Infliximab )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ13
96クローン病5
271強直性脊椎炎4

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02728934
(ClinicalTrials.gov)
February 25, 201631/3/2016Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid ArthritisComparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid ArthritisArthritis, RheumatoidBiological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar InfliximabJanssen Scientific Affairs, LLCNULLCompleted18 YearsN/AAll1279United States
2EUCTR2007-003288-36-GB
(EUCTR)
04/11/200903/10/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
3EUCTR2007-003288-36-FR
(EUCTR)
08/12/200821/10/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
4EUCTR2007-003288-36-FI
(EUCTR)
28/11/200830/09/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
5EUCTR2007-003288-36-DE
(EUCTR)
10/11/200803/09/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
6EUCTR2007-003288-36-NL
(EUCTR)
15/10/200811/07/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
7EUCTR2007-003288-36-AT
(EUCTR)
01/10/200818/08/2008A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTARTA Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
8NCT00714493
(ClinicalTrials.gov)
July 200810/7/2008RESTART C0168Z05 Rheumatoid Arthritis StudyA Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).Rheumatoid ArthritisBiological: InfliximabCentocor Ortho Biotech Services, L.L.C.Schering-PloughCompleted18 YearsN/AAll203Phase 4United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium
9EUCTR2007-004694-26-BE
(EUCTR)
17/09/200710/09/2007A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UAA Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -
Saint-Luc Universitary HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Belgium
10NCT00236028
(ClinicalTrials.gov)
November 20047/10/2005A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid ArthritisA Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid ArthritisRheumatoid ArthritisDrug: InfliximabCentocor, Inc.NULLCompleted18 Years75 YearsBoth607Phase 3NULL
11NCT00794898
(ClinicalTrials.gov)
July 1, 200319/11/2008Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate TreatmentArthritis, RheumatoidBiological: Infliximab (Remicade)Merck Sharp & Dohme Corp.NULLCompleted18 Years75 YearsAll19Phase 4NULL
12NCT00036387
(ClinicalTrials.gov)
October 20019/5/2002A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.Arthritis, RheumatoidDrug: InfliximabCentocor, Inc.NULLCompleted18 YearsN/ABoth347Phase 3United States
13NCT00036374
(ClinicalTrials.gov)
October 20019/5/2002A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid ArthritisA Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid ArthritisRheumatoid Arthritis, JuvenileDrug: InfliximabCentocor, Inc.NULLCompleted4 Years18 YearsBoth123Phase 3United States

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-005629-21-HU
(EUCTR)
14/08/201411/06/2014Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s diseaseDiagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease Crohn’s disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab
INN or Proposed INN: INFLIXIMAB
First Department of Medicine, University of SzegedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Hungary
2NCT00207675
(ClinicalTrials.gov)
February 200313/9/2005A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's DiseaseA Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.Crohn DiseaseDrug: infliximabCentocor, Inc.Centocor BVCompleted6 Years17 YearsBoth112Phase 3NULL
3NCT00261976
(ClinicalTrials.gov)
February 20022/12/2005A Long-term Safety Study of Infliximab (Remicade)Long-term Safety Follow-up of REMICADE (RESULTS)Arthritis, Rheumatoid;Crohn Disease;PsoriasisDrug: Infliximab (Remicade)Centocor, Inc.Centocor BVCompletedN/AN/ABoth2971United States;Argentina;Austria;Belgium;Canada;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Netherlands;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom
4NCT00207662
(ClinicalTrials.gov)
July 200013/9/2005A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's DiseaseACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: infliximab or placeboCentocor, Inc.NULLCompleted18 YearsN/ABoth580Phase 3NULL
5NCT00207766
(ClinicalTrials.gov)
June 200013/9/2005A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's DiseaseACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S DiseaseCrohn DiseaseDrug: infliximab or placeboCentocor, Inc.NULLCompleted18 YearsN/ABoth306Phase 3NULL

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02359903
(ClinicalTrials.gov)
February 201530/1/2015Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing SpondylitisInternational Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Infliximab (BCD-055);Drug: Infliximab (Remicade)BiocadNULLCompleted18 Years65 YearsAll90Phase 1Belarus;Russian Federation
2NCT00936143
(ClinicalTrials.gov)
January 20087/7/2009Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing SpondylitisAn Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing SpondylitisSpondylitisDrug: infliximabGu JieruoNULLCompleted16 Years65 YearsBoth70Phase 4China
3NCT00779935
(ClinicalTrials.gov)
October 1, 200423/10/2008Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot StudySpondylitis, AnkylosingBiological: RemicadeMerck Sharp & Dohme Corp.NULLCompleted18 Years70 YearsAll44Phase 4NULL
4NCT00207701
(ClinicalTrials.gov)
September 200213/9/2005A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug TherapyAnkylosing SpondylitisDrug: infliximabCentocor, Inc.Centocor BV, NetherlandsCompleted18 YearsN/ABoth279Phase 3NULL