Chimeric IgG1 monoclonal antibody ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
96Crohn disease4

96. Crohn disease


Clinical trials : 2,442 Drugs : 1,278 - (DrugBank : 248) / Drug target genes : 142 - Drug target pathways : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-002815-10-DE
(EUCTR)
12/12/200525/04/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
2EUCTR2004-002815-10-GB
(EUCTR)
25/07/200526/05/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Spain;Denmark;Austria;Germany;United Kingdom;Sweden
3EUCTR2004-002815-10-DK
(EUCTR)
07/07/200510/07/2008Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
4EUCTR2004-002815-10-SE
(EUCTR)
24/05/200511/04/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden