Imuran ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病13
97潰瘍性大腸炎10

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000469-33-NL
(EUCTR)
12/10/202125/03/2021Scientific medical research comparing the effectiveness of Infliximab by injection in the abdominal tissiue (subcutaneous) monotherapy and infliximab subcutaneous injection with anti-inflammatory drugs in the treatment of moderate to severe chronic inflammatory bowel disease.A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn’s Disease. - DIRECT CD Crohns disease;Therapeutic area: Body processes [G] - Biological Phenomena [G16]Trade Name: Remsima
Product Name: Remsima
Product Code: EMEA/H/C/002576
Trade Name: Puri Nethol
Product Name: Puri Nethol
Product Code: RVG00859
Trade Name: Imuran
Product Name: Imuran
Trade Name: Thiosix
Product Name: Thiosix
Product Code: RVG 114681
Trade Name: Ebetrex 15 mg = 0,75 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml
Product Name: Ebetrex
Product Code: RVG 116648
Amsterdam UMC location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 3;Phase 4Netherlands
2EUCTR2016-000522-18-NL
(EUCTR)
28/12/201703/07/2017Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. - REDUCE-RISKincd-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprine
Product Name: imuran
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: methotrexate
Product Name: methotrexate
Product Code: L01BA
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBDNetNULLNot RecruitingFemale: yes
Male: yes
312Phase 4France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
3EUCTR2014-002311-41-GB
(EUCTR)
14/07/201530/06/2015A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapyA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy (SPARE) - SPARE Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Remicade
Product Name: INFLIXIMAB
Trade Name: Imuran
Product Name: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Mercaptopurine
Product Name: Mercaptopurine
University of EdinburghNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300France;Belgium;Germany;United Kingdom;Sweden
4EUCTR2008-001131-35-NL
(EUCTR)
14/05/200829/05/2008Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trialAzathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 monthsTrade Name: Remicade
Product Name: Infliximab
Product Code: EU/1/99/116/003
Trade Name: Imuran
Product Name: Azathioprine
Product Code: RVG 05565
Academic Medical Center, department of Gastroenterology and hepatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
5EUCTR2004-002815-10-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
6EUCTR2004-002815-10-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
7EUCTR2004-002815-10-ES
(EUCTR)
18/07/200516/05/2006Multicenter, 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: 7.1;Classification code 10011401
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product 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
8EUCTR2004-002815-10-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
9NCT00113503
(ClinicalTrials.gov)
July 20058/6/2005Imuran Dosing in Crohn's Disease StudyA Multi-site Trial of Azathioprine Dosing in Crohn's DiseaseCrohn's DiseaseDrug: Azathioprine weight-based dose;Drug: Azathioprine individualised doseNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Prometheus LaboratoriesTerminated10 Years70 YearsAll50Phase 2United States;Canada
10EUCTR2005-001148-22-SK
(EUCTR)
27/06/200512/05/2005A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicableA 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable Crohn's disease
MedDRA version: 7.1;Level: Low;Classification code 10011401
Trade Name: Certican
Product Name: Certican
Product Code: RAD001
INN or Proposed INN: Everolimus
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: Azathioprine
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Slovakia
11EUCTR2004-002815-10-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
12EUCTR2004-002815-10-AT
(EUCTR)
04/05/200530/03/2005Multicenter, 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: 7.1;Classification code 10011401
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product 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
500Spain;Denmark;Austria;Germany;United Kingdom;Sweden
13NCT00098111
(ClinicalTrials.gov)
April 20053/12/2004Imuran (Azathioprine) Dose-Ranging Study in Crohn's DiseaseA Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS)Crohn's DiseaseDrug: azathioprineMassachusetts General HospitalNULLTerminated14 YearsN/ABoth31Phase 3United States

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-002670-22-GB
(EUCTR)
11/06/200801/08/2007 Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
2EUCTR2006-002670-22-SK
(EUCTR)
08/02/200815/04/2008 Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
3EUCTR2006-002670-22-IT
(EUCTR)
27/11/200704/10/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) moderately to severely active Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: imuran
INN or Proposed INN: azathioprine
SCHERING-PLOUGHNULLNot RecruitingFemale: yes
Male: yes
600Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy
4EUCTR2006-002670-22-DE
(EUCTR)
31/10/200712/06/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
600Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
5EUCTR2006-002670-22-PT
(EUCTR)
12/10/200720/07/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
6EUCTR2006-002670-22-ES
(EUCTR)
20/09/200726/07/2007 Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). Colitis Ulcerosa
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom
7EUCTR2006-002670-22-FR
(EUCTR)
07/09/200714/06/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
8EUCTR2006-002670-22-CZ
(EUCTR)
29/08/200720/07/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
600Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy
9EUCTR2006-002670-22-HU
(EUCTR)
09/08/200704/07/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
600Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
10EUCTR2006-002670-22-BE
(EUCTR)
25/07/200715/06/2007 Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom