97. 潰瘍性大腸炎 [臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
34 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003558-26-GB11/02/202005/11/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
2EUCTR2018-003558-26-FR10/12/201908/02/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
ABIVAXNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
232 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany
3EUCTR2018-003558-26-DE30/10/201915/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands
4EUCTR2018-003558-26-BE29/08/201927/05/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
5EUCTR2018-003558-26-SI12/06/201907/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03760003June 11, 201929/11/2018Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative ColitisA Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid TreatmentUlcerative ColitisDrug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: PlaceboAbivax S.A.NULLRecruiting18 Years75 YearsAll232Phase 2United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
7EUCTR2018-003558-26-SK23/05/201920/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;United States;Belarus;Serbia;Slovakia;Hungary;Canada;Belgium;Poland;Germany
8EUCTR2018-003558-26-HU21/05/201925/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
232Phase 2United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
9EUCTR2018-003558-26-PL20/05/201912/04/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2Serbia;United States;Belarus;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany
10EUCTR2016-004112-35-SE04/04/201821/06/2017A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel diseaseLow-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11JPRN-UMIN0000309882018/02/0101/02/2018Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy Ulcerative ColitisInduce azathioprine and continue maintenance therapy by azathioprine
Induce adalimumab and continue maintenance therapy by adalimumab
Sakura Medical Center, Toho universityNULLPending15years-oldNot applicableMale and Female53Not appl1cableJapan
12NCT03151525May 8, 20178/5/2017Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative ColitisComparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by InfliximabColitis, UlcerativeDrug: Azathioprine;Drug: InfliximabIstituto Clinico HumanitasAgenzia Italiana del FarmacoRecruiting18 Years65 YearsAll100Phase 4Italy
13NCT03101800December 14, 201627/1/2017Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative ColitisLow-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled TrialColitis, Ulcerative;Colitis Ulcerative ExacerbationDrug: Azathioprine and Allopurinol;Drug: AzathioprineHvidovre University HospitalAalborg University Hospital;Zealand University Hospital;University of Copenhagen;Odense University Hospital;Aarhus University Hospital;Regional Hospital Viborg;Vejle Hospital;Sydvestjysk Hospital EsbjergUnknown status18 Years80 YearsAll84Phase 3Denmark
14NCT02425852December 201621/4/2015A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLRecruiting18 YearsN/AAll146Phase 4France
15EUCTR2016-002433-30-DK25/08/201621/06/2016Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitisLow-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Allopurinol
INN or Proposed INN: ALLOPURINOL
Hvidovre HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02579733February 1, 201616/10/2015Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: Azathioprine;Drug: PlaceboKyungpook National University HospitalCelltrionTerminated18 Years80 YearsAll16Phase 4Korea, Republic of
17NCT02413047May 20156/3/2015Evaluate if Response to Infliximab or Adalimumab May be Regained With an ImmunomodulatorA Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an ImmunomodulatorInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: Azathioprine;Drug: 6 mercaptopurine;Drug: MethotrexateIndiana UniversityNULLTerminated18 Years80 YearsAll3N/AUnited States
18EUCTR2012-001653-13-IT10/07/201327/03/2013New Therapeutic Strategy in Ulcerative ColitisNew Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in PediatricPatients Ulcerative Colitis
MedDRA version: 15.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: AZAFOR 50mg
Product Name: AZATIOPRINA
Product Code: AZA
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE
Dipartimento di Pediatria Università Federico II di NapoliNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Italy
19JPRN-UMIN0000037852010/07/0101/07/2010Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. Ulcerative colitis5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).

5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female80Phase 3Japan
20NCT00984568November 200924/9/2009Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter StudyColitis, UlcerativeBiological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: AzathioprineMerck Sharp & Dohme Corp.NULLTerminated18 YearsN/AAll28Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-010065-23-DE17/08/200914/04/2009Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXConventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10033007Term: Other ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone
Essex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
22EUCTR2006-002670-22-GB11/06/200801/08/2007 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
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): Therapeut1c exploratory (Phase 2): Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4):Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
23EUCTR2006-002670-22-SK08/02/200815/04/2008 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
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): Therapeut1c exploratory (Phase 2): Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4):Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
24EUCTR2006-002670-22-IT27/11/200704/10/2007Comparison 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: 14.1Level: PTClassification code 10009900Term: Colitis ulcerativeSystem 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
25EUCTR2006-002670-22-DE31/10/200712/06/2007Comparison 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: 9.1Level: LLTClassification code 10045365Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-002670-22-PT12/10/200720/07/2007Comparison 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: 9.1Level: LLTClassification code 10045365Term: 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
27EUCTR2006-002670-22-ES20/09/200726/07/2007 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
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom
28EUCTR2006-002670-22-FR07/09/200714/06/2007Comparison 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: 9.1Level: LLTClassification code 10045365Term: 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
29NCT00521950September 200727/8/2007Cost-effectiveness of TPMT PharmacogeneticsPharmacogenetic Testing in the Clinical Setting: is Screening for TPMT Genotype a Cost-effective Treatment Strategy? - The First Prospective Randomized Controlled Trial Within the Dutch Health Care System.Inflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisGenetic: TPMT genotyping; Drug: azathioprine or 6-mercaptopurine;Drug: azathioprine (AZA) or 6-mercaptopurine (6-MP)ZonMw: The Netherlands Organisation for Health Research and DevelopmentRadboud UniversityCompleted18 YearsN/ABoth853N/ANetherlands
30EUCTR2006-002670-22-CZ29/08/200720/07/2007Comparison 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: 9.1Level: LLTClassification code 10045365Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-002670-22-HU09/08/200704/07/2007Comparison 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: 9.1Level: LLTClassification code 10045365Term: 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
32EUCTR2006-002670-22-BE25/07/200715/06/2007 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
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
33NCT00537316July 200728/9/2007Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)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 ColitisBiological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusionMerck Sharp & Dohme Corp.NULLTerminated21 YearsN/AAll242Phase 3Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
34EUCTR2005-000695-40-GB27/09/200517/08/2005A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trialA randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial The medical condition is Ulcerative Colitis.University of NottinghamNULLNot Recruiting Female: yes
Male: yes
420 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom