Cimzia 200 mg solution for injection ( DrugBank: - )


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1
96クローン病1
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
1EUCTR2009-017998-37-BE
(EUCTR)
08/06/201211/04/2012Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Product Name: 99mTc-S-HYNIC Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Ghent University HospitalNULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium

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
1EUCTR2009-017998-37-BE
(EUCTR)
08/06/201211/04/2012Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Product Name: 99mTc-S-HYNIC Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Ghent University HospitalNULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium

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
1EUCTR2017-000957-37-NL
(EUCTR)
18/07/201831/10/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of
2EUCTR2017-000957-37-DE
(EUCTR)
15/11/201714/07/2017Study to test the efficacy and safety of bimekizumab andcertolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of
3EUCTR2017-000957-37-GR
(EUCTR)
05/10/201713/09/2017Study to test the efficacy and safety of Bimekizumab andCertolizumab Pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Moldova, Republic of;Germany;Netherlands;Russian Federation;Australia;Poland;Greece;Czech Republic;United States
4EUCTR2017-000957-37-CZ
(EUCTR)
25/09/201712/07/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitis A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of