97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,468 - (DrugBank : 259) / 標的遺伝子数 : 143 - 標的パスウェイ数 : 201

  
140 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001811-26-BE
(EUCTR)
18/11/202122/07/2021IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Belgium;Netherlands
2NCT04999228
(ClinicalTrials.gov)
October 1, 20215/8/2021Top Down Versus Step up in Pediatric Ulcerative ColitisFirst-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative ColitisUlcerative Colitis;Infliximab;ChildrenDrug: Infliximab;Drug: CorticosteroidsChildren's Hospital of Fudan UniversityNULLNot yet recruiting6 Years18 YearsAll40Phase 4NULL
3EUCTR2018-003524-36-NO
(EUCTR)
06/09/202116/06/2021Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Trade Name: Metoject
Trade Name: Puri-Nethol
Trade Name: Remsima
Trade Name: Inflectra
UMC Amsterdam location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 4France;Ireland;Netherlands;Norway;United Kingdom
4EUCTR2021-002211-65-ES
(EUCTR)
13/08/202111/06/2021EFFECT OF TOFACITINIB ON COAGULATIONEFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Level: PT;Classification code 10009790;Term: Coagulation time;System Organ Class: 10022891 - Investigations
MedDRA version: 21.0;Classification code 10061684;Term: Platelet function test;System Organ Class: 10022891 - Investigations;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Trade Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: Tofacitinib
INN or Proposed INN: TOFACITINIB
Fundación Española de GastroenterologíaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Spain
5NCT04879966
(ClinicalTrials.gov)
May 17, 20216/5/2021A Cohort Study Comparing IFX to CS for Moderate to Severe UCA Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisDrug: Infliximab;Drug: CorticosteroidSixth Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting18 Years70 YearsAll342China
6EUCTR2019-002942-19-DK
(EUCTR)
12/03/202105/11/2020Nordic study of treatment strategy in inflammatory bowel diseaseNORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile Crohn's disease and Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Trade Name: Puri-nethol
INN or Proposed INN: MERCAPTOPURINE
Region Örebro länNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 4Denmark
7JPRN-UMIN000043165
2021/02/0131/01/2021Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel diseaseSafety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease Crohn's disease, Ulcerative colitis, IBDUwitching from originator infliximab to infliximab biosimilar CT-P13Fukuoka University Chikushi HospitalNULLPendingNot applicableNot applicableMale and Female220Not selectedJapan
8JPRN-jRCT1031200329
28/01/202128/01/2021UC Bio StudyOpen-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness Ulcerative colitis
Biologics;D003093
Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks.
Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks
Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy.
Body weight dose
55kg or less 260mg
55-85kg 390mg
85kg or more 520mg

After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks.
Naganuma MakotoNULLRecruiting>= 16age oldNot applicableBoth231N/AJapan
9NCT04331639
(ClinicalTrials.gov)
November 1, 202023/3/2020High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic TherapyImplementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or VedolizumabInflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D DeficiencyDietary Supplement: vitamin D3Boston Children's HospitalNULLRecruiting5 Years25 YearsAll50Phase 2United States
10EUCTR2020-001811-26-NL
(EUCTR)
30/09/202008/07/2020IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Netherlands
11NCT04205643
(ClinicalTrials.gov)
September 2, 202018/12/2019CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisBiological: CT-P13 SC (Infliximab);Other: Placebo SCCelltrionNULLActive, not recruiting18 Years75 YearsAll548Phase 3Poland
12EUCTR2019-004652-11-SI
(EUCTR)
28/08/202031/08/2020A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative ColitisRANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: RO5490261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany
13EUCTR2019-003849-15-HR
(EUCTR)
05/06/202020/11/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
14EUCTR2019-003849-15-CZ
(EUCTR)
28/05/202016/03/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3Belarus;Serbia;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of
15EUCTR2019-003849-15-ES
(EUCTR)
12/05/202028/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
16EUCTR2019-003849-15-IT
(EUCTR)
15/04/202017/06/2021Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis - NA Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Name: Remsima (CT-P13)
Product Code: [Remsima (CT-P13)]
INN or Proposed INN: INFLIXIMAB
Product Name: CT-P13
Product Code: [CT-p13]
INN or Proposed INN: INFLIXIMAB
CELLTRION INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
17EUCTR2019-003849-15-FR
(EUCTR)
03/04/202003/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
18EUCTR2019-003849-15-BG
(EUCTR)
03/04/202007/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
615Phase 3Serbia;Belarus;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of
19EUCTR2019-003849-15-GR
(EUCTR)
03/04/202002/04/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
20EUCTR2018-003524-36-IE
(EUCTR)
25/03/202005/11/2019Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: NA
Product Code: NA
INN or Proposed INN: INFLIXIMAB
Trade Name: Metoject
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
UMC Amsterdam location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 4Ireland;Netherlands
21EUCTR2019-003849-15-AT
(EUCTR)
20/03/202006/02/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative ColitisA Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
615Phase 3Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany;Serbia;Belarus;United States
22EUCTR2019-003068-39-NL
(EUCTR)
20/11/201904/11/2019In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
UMC UtrechtNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Netherlands
23EUCTR2017-004496-31-NL
(EUCTR)
20/09/201927/09/2018A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: CNTO312
INN or Proposed INN: INFLIXIMAB
Janssen Biologics BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of
24NCT03885713
(ClinicalTrials.gov)
September 10, 20194/3/2019Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel DiseaseIdentification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry ApproachesInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisBiological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumabFundación de Investigación Biomédica - Hospital Universitario de La PrincesaNULLRecruiting18 YearsN/AAll180Phase 4Spain
25NCT03937609
(ClinicalTrials.gov)
September 4, 201930/4/2019TITRATE (inducTIon for acuTe ulceRATivE Colitis)Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients With Acute Severe Ulcerative ColitisColitis, UlcerativeDrug: InfliximabAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)PfizerRecruiting18 YearsN/AAll120Phase 4Netherlands
26EUCTR2018-003524-36-NL
(EUCTR)
25/04/201919/11/2018Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Trade Name: Metoject
Trade Name: Puri-Nethol
UMC Amsterdam location AMCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
27EUCTR2018-004587-61-NL
(EUCTR)
23/04/201913/05/2019Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximabDeep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: TOFACITINIB
Trade Name: Inflectra
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Erasmus Medical CenterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
28NCT03884439
(ClinicalTrials.gov)
March 18, 20194/3/2019Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)Crohn's Disease;Ulcerative ColitisDrug: Infliximab [infliximab biosimilar 3]PfizerNULLRecruitingN/AN/AAll300Japan
29NCT03942861
(ClinicalTrials.gov)
February 21, 201925/4/2019Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Ulcerative Colitis;Ultrasound Therapy; ComplicationsDrug: Solu-MedrolCopenhagen University Hospital at HerlevNULLRecruiting18 Years70 YearsAll50Denmark
30EUCTR2017-004496-31-IT
(EUCTR)
18/02/201917/06/2021A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: [CNTO148]
INN or Proposed INN: GOLIMUMAB
Trade Name: SIMPONI
Product Name: Golimumab
Product Code: [CNTO148]
INN or Proposed INN: GOLIMUMAB
Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml
Trade Name: Simponi
Product Name: Golimumab
Product Code: [CNTO148]
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: [CNTO312]
INN or Proposed INN: INFLIXIMAB
Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 3France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of
31EUCTR2017-004496-31-PL
(EUCTR)
30/01/201906/12/2018A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: CNTO312
INN or Proposed INN: INFLIXIMAB
Janssen Biologics BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Taiwan;Spain;Belgium;Brazil;Poland;Israel;Netherlands;Italy;Korea, Republic of
32NCT03679546
(ClinicalTrials.gov)
January 4, 201918/9/2018EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative ColitisEFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical TrialUlcerative ColitisDrug: Infliximab;Drug: Vedolizumab InjectionRennes University HospitalNULLRecruiting18 Years75 YearsAll150Phase 4France
33EUCTR2018-002925-47-ES
(EUCTR)
28/12/201816/11/2018prediction of response to therapy in inflammatory bowel diseaseIdentification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches Inflammatory bowel disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;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: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Vedolizumab
INN or Proposed INN: VEDOLIZUMAB
Other descriptive name: VEDOLIZUMAB
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
34NCT03765450
(ClinicalTrials.gov)
December 21, 20184/12/2018Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative ColitisPharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative ColitisUlcerative ColitisDrug: InfliximabAlimentiv Inc.NULLRecruiting18 YearsN/AAll30United States;Canada
35EUCTR2017-004496-31-FR
(EUCTR)
17/12/201814/09/2018A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Janssen Biologics BVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
36EUCTR2017-004496-31-BE
(EUCTR)
07/11/201825/07/2018A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: CNTO312
INN or Proposed INN: INFLIXIMAB
Janssen Biologics BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Taiwan;Spain;Poland;Brazil;Belgium;Israel;Netherlands;Italy;Korea, Republic of
37NCT03596645
(ClinicalTrials.gov)
October 29, 201813/7/2018A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Golimumab;Drug: InfliximabJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll100Phase 3United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan
38EUCTR2017-004496-31-ES
(EUCTR)
15/10/201828/08/2018A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative ColitisA Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Janssen Biologics BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 3France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
39EUCTR2018-002673-21-FR
(EUCTR)
04/09/201806/07/2018EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Centre Hospitalier Universitaire de RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4France
40NCT03452501
(ClinicalTrials.gov)
August 26, 201826/2/2018Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia PatientsAn Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CDInflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative ColitisDrug: InfliximabHikma Pharmaceuticals LLCNULLCompleted18 YearsN/AAll157Saudi Arabia
41EUCTR2017-002108-28-DE
(EUCTR)
25/07/201827/03/2018A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remissionA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: PF-06687234
Other descriptive name: F8IL10
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
76Phase 2United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
42EUCTR2018-001546-33-GB
(EUCTR)
11/07/201814/05/2018The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s diseaseIBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0 Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Flixabi
Product Name: Flixabi
INN or Proposed INN: Infliximab
University Southampton Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
200Phase 4United Kingdom
43NCT04775732
(ClinicalTrials.gov)
June 1, 201825/2/2021Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel DiseaseUltra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic TrialCrohn Disease;Ulcerative ColitisBiological: infliximab therapeutic drug monitoringImelda GI Clinical Research CenterNULLCompletedN/AN/AAll187Phase 4Belgium
44EUCTR2017-002108-28-IT
(EUCTR)
15/05/201822/01/2021A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remissionA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Dekavil
Product Code: [PF-06687234]
INN or Proposed INN: PF-06687234
PFIZER INCNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;Serbia;Saudi Arabia;Spain;Belgium;Korea, Democratic People's Republic of;Australia;Israel;Germany;Italy
45NCT03209232
(ClinicalTrials.gov)
April 16, 20181/7/2017Infliximab Accelerated Induction in Moderate to Severe Pediatric UCInfliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) TrialUlcerative ColitisDrug: InfliximabSchneider Children's Medical Center, IsraelNULLTerminated6 Years18 YearsAll10N/AIsrael
46EUCTR2017-002108-28-ES
(EUCTR)
12/04/201820/04/2018A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remissionA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: Dekavil
Other descriptive name: F8IL10
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of
47EUCTR2017-002108-28-BE
(EUCTR)
30/03/201822/03/2018A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remissionA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: PF-06687234
Other descriptive name: F8IL10
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
76Phase 2United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
48NCT03269695
(ClinicalTrials.gov)
December 20, 201730/8/2017Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)Ulcerative ColitisDrug: PF-06687234;Drug: PlaceboPfizerNULLTerminated18 Years75 YearsAll20Phase 2United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain
49JPRN-UMIN000027465
2017/05/2924/05/2017Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitisEfficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients ulcerative colitisInfliximab (5mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)
University of ToyamaNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
50NCT03151525
(ClinicalTrials.gov)
May 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
51NCT02994836
(ClinicalTrials.gov)
April 21, 201724/10/2016GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic EvaluationCrohn's Disease;Inflammatory Bowel Disease;Ulcerative ColitisBiological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus)Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaNULLActive, not recruiting18 YearsN/AAll194Phase 4Spain
52EUCTR2016-002707-25-IT
(EUCTR)
31/03/201713/01/2021n.a.Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a. patients with ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
INN or Proposed INN: INFLIXIMAB
Trade Name: AZAFOR - 50 MG COMPRESSE RIVESTITE CON FILM 50 COMPRESSE IN BLISTER PVC/PVDC/AL
INN or Proposed INN: AZATIOPRINA
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Italy
53EUCTR2016-001409-18-NO
(EUCTR)
06/12/201609/05/2016A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrenceA prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: 1.Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Helse More og Romsdal Hospital TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Norway
54NCT02425852
(ClinicalTrials.gov)
December 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
55JPRN-UMIN000024936
2016/11/3022/11/2016Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis Ulcerative colitispatients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.Keio University Gastroenterology and HepatologyNULLRecruiting16years-old150years-oldMale and Female30Not selectedJapan
56EUCTR2016-002061-54-IT
(EUCTR)
13/10/201615/11/2018Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINULLNot RecruitingFemale: yes
Male: yes
250Phase 4Italy
57EUCTR2014-004904-31-BE
(EUCTR)
21/09/201629/07/2016A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remsima (infliximab)Mundipharma Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
156Phase 4Belgium;Netherlands
58NCT02770040
(ClinicalTrials.gov)
July 20169/5/2016Optimising Infliximab Induction Therapy for Acute Severe Ulcerative ColitisPREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled TrialUlcerative ColitisDrug: InfliximabAustin HealthUniversity of MelbourneActive, not recruiting18 Years80 YearsAll138Phase 4Australia
59EUCTR2016-001278-13-FI
(EUCTR)
08/06/201615/04/2016Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitisImmunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD Ulcerative colitis and Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB
Taina SipponenNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Finland
60EUCTR2015-004618-10-BE
(EUCTR)
19/04/201620/11/2015PhArmaCo-kinetics of InFliximab during treatment InductionStudy of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Inflectra
CUB- Hopital ErasmeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Belgium
61EUCTR2015-001954-14-NL
(EUCTR)
14/09/201525/08/2015Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research ulcerative colitis and 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: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion
Product Name: Inflectra 100 mg powder for concentrate for solution for infusion
Trade Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Code: EMEA/H/C/000240
SanteonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
62JPRN-UMIN000018745
2015/09/0101/09/2015The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy ulcerative colitisAdministration of Infliximab and enteral nutrition
Administration of Infliximab
Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatologyNULLPending15years-old75years-oldMale and Female40Not selectedJapan
63EUCTR2014-004904-31-NL
(EUCTR)
19/05/201526/01/2015A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Remsima (infliximab)Mundipharma Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
64NCT02413047
(ClinicalTrials.gov)
May 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
65NCT02539368
(ClinicalTrials.gov)
April 22, 201522/7/2015Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel DiseasePOST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's DiseaseDrug: CT-P13;Drug: RemicadePfizerHospira, now a wholly owned subsidiary of PfizerCompleted18 YearsN/AAll2565Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
66EUCTR2013-004282-14-NL
(EUCTR)
13/01/201504/08/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of
67EUCTR2013-004282-14-PT
(EUCTR)
09/01/201523/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
68NCT02136069
(ClinicalTrials.gov)
December 24, 201415/4/2014A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection)Hoffmann-La RocheNULLCompleted18 Years80 YearsAll397Phase 3Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam
69EUCTR2013-004282-14-BE
(EUCTR)
11/12/201427/08/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
70EUCTR2013-004282-14-ES
(EUCTR)
25/11/201406/08/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Roche Farma S.A. en nombre de F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
71EUCTR2013-004282-14-IT
(EUCTR)
10/11/201416/09/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
72EUCTR2013-004282-14-DE
(EUCTR)
10/11/201418/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
73EUCTR2013-004282-14-HU
(EUCTR)
29/10/201430/10/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
74EUCTR2013-004282-14-NO
(EUCTR)
17/10/201404/08/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of;Canada;Belgium;Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary
75NCT02148640
(ClinicalTrials.gov)
October 201423/5/2014The NOR-SWITCH StudyA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDYRheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis ChronicDrug: Innovator infliximab;Drug: Biosimilar infliximabDiakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityCompleted18 YearsN/AAll482Phase 4Norway
76EUCTR2013-004282-14-GB
(EUCTR)
29/09/201415/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
77EUCTR2013-004282-14-CZ
(EUCTR)
16/09/201418/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania
78JPRN-UMIN000015068
2014/09/0505/09/2014An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis Ulcerative colitisInfliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks
GMA will be administrated 10 times
Hiroshima University Hospital, Department of EndoscopyNULLEnrolling by invitation20years-oldNot applicableMale and Female150Not applicableJapan
79EUCTR2013-004282-14-AT
(EUCTR)
03/09/201422/07/2014A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
80EUCTR2014-002056-40-NO
(EUCTR)
12/08/201413/06/2014A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasisA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Diakonhjemmet Hospital ASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway
81EUCTR2013-004282-14-FR
(EUCTR)
28/07/201422/06/2015A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
82JPRN-UMIN000014275
2014/06/2424/06/2014Efficacy of infliximab for refractory pouchitis with complexed anal fistula ulcerative colitisinfliximabHyogo College of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female10Phase 1Japan
83JPRN-UMIN000013716
2014/04/1515/04/2014A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis ulcerative colitisAfter administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg.
Infliximab monotherapy
Yokohama City University Medical CenterNULLComplete: follow-up complete16years-oldNot applicableMale and Female40Phase 2Japan
84EUCTR2013-002651-15-NL
(EUCTR)
03/03/201418/09/2013Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study Crohns diseaseUlcerative colitis
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade (infliximab)
Product Name: infliximab
Zon MWNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
85JPRN-UMIN000013033
2014/02/0101/02/2014Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. Ulcerative colitisStudy start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)Department of Internal Medicine,Juntendo UniversityNULLPending20years-oldNot applicableMale and Female30Not selectedJapan
86EUCTR2011-001332-29-AT
(EUCTR)
02/12/201307/11/2013The degradation and elimination of InfliximabPharmacokinetics of Infliximab Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und HepatologieNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
87NCT01971814
(ClinicalTrials.gov)
November 201317/10/2013Early Serum Infliximab Levels in Severe Ulcerative Colitis.Early Serum Infliximab Levels in Severe Ulcerative ColitisUlcerative Colitis (UC);Inflammatory Bowel DiseaseDrug: InfliximabUniversity of California, San FranciscoNULLCompleted18 YearsN/ABoth11Phase 1United States
88JPRN-UMIN000013370
2013/06/0707/03/2014Efficacy of infliximab therapy for refractory pouchitis ulcerative colitis, pouchitisinfliximabInflammatory bowel disease center, Hyogo college of medicineNULLComplete: follow-up complete18years-old80years-oldMale and Female10Phase 1Japan
89JPRN-UMIN000013371
2013/06/0507/03/2014Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis ulcerative colitisinfliximabHyogo college of medicineNULLComplete: follow-up complete20years-old80years-oldMale and Female10Not selectedJapan
90JPRN-UMIN000010612
2013/05/0101/05/2013A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis Ulcerative colitisTacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period.
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female130Phase 4Japan
91NCT02073526
(ClinicalTrials.gov)
May 20139/1/2014Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel DiseaseAnti-TNF-alpha Trough Level Measurements in Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisDrug: Infliximab, adalimumab, certolizumab pegolOslo University HospitalNULLCompleted18 YearsN/ABoth1230N/ANorway
92NCT01846026
(ClinicalTrials.gov)
April 201330/4/2013Ulcerative Colitis and Vitamin D SupplementationImmunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.Ulcerative ColitisDrug: Vitamin D;Drug: placeboUniversity Hospital of North NorwayNULLWithdrawn18 YearsN/ABoth0Phase 1/Phase 2Norway
93NCT01804166
(ClinicalTrials.gov)
March 21, 20131/2/2013A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)Hepatosplenic T-Cell LymphomaDrug: Infliximab;Drug: GolimumabJanssen Scientific Affairs, LLCNULLCompletedN/AN/AAll1Phase 4United States
94EUCTR2011-006084-22-GB
(EUCTR)
04/10/201215/08/2012Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatmentUtilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease Inflammatory bowel disease
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;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
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Royal Liverpool University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
0United Kingdom
95JPRN-UMIN000015297
2012/09/1901/10/2014The feasibility study of accelated infliximab infusion from initial administrationThe feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNULLRecruiting20years-old70years-oldMale and Female54Phase 2Japan
96JPRN-UMIN000007806
2012/06/0101/05/2012The feasibility study of accelated infliximab infusion during maintenance phase patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female54Phase 2Japan
97NCT01551290
(ClinicalTrials.gov)
April 20127/3/2012A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: Infliximab;Drug: PlaceboXian-Janssen Pharmaceutical Ltd.NULLCompleted18 Years65 YearsBoth99Phase 3China
98JPRN-UMIN000007341
2012/02/0121/02/2012The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximabThe study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab ulcerative colitisPatients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54).
Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54).
Tohoku University Graduate School of Medicine (Tohoku University Hospital)NULLComplete: follow-up complete20years-oldNot applicableMale and Female90Not applicableJapan
99JPRN-UMIN000006141
2011/10/0112/08/2011Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis ulcerative colitisPatients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).
Department of Gastroenterology and Hepatology, Kyoto University HospitalNULLComplete: follow-up complete16years-old75years-oldMale and Female50Not applicableJapan
100EUCTR2011-002061-38-BE
(EUCTR)
29/06/201108/06/2011Treating patients with infliximab based on their trough levelsA randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT 2) Crohn's disease and ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade
Product Name: Remicade
Product Code: Remicade
INN or Proposed INN: INFLIXIMAB
Katholieke Universiteit LeuvenNULLNot RecruitingFemale: yes
Male: yes
Phase 4Belgium
101NCT01346826
(ClinicalTrials.gov)
May 20112/5/2011Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled TrialCrohn's Disease;Ulcerative ColitisDrug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusionAsan Medical CenterNULLCompleted16 Years80 YearsBoth145Phase 4Korea, Republic of
102NCT01408810
(ClinicalTrials.gov)
February 201120/7/2011Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative ColitisHistological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis PatientsUlcerative ColitisDrug: InfliximabGrupo de Estudo da Doença Inflamatória IntestinalNULLCompleted18 Years64 YearsBoth21Phase 4Portugal
103EUCTR2009-013890-16-PT
(EUCTR)
28/05/201021/12/2009Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - HericaHerica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients.
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
Trade Name: Remicade
Product Name: Remicade
GEDII - Grupo de Estudo da Doença inflamatória IntestinalNULLNot RecruitingFemale: yes
Male: yes
20Portugal
104EUCTR2008-005237-30-NL
(EUCTR)
01/12/200918/08/2009A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative ColitisA Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP Pediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima and Inflectra
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6000United States;Canada;Netherlands;Sweden
105NCT00984568
(ClinicalTrials.gov)
November 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
106EUCTR2009-015649-21-NO
(EUCTR)
21/10/200916/09/2009Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab. Ulcerative colitisTrade Name: Dekristol
Product Name: cholecalciferol
Product Code: na
Medical clinic, University Hospital of North NorwayNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Norway
107NCT02322008
(ClinicalTrials.gov)
September 200917/12/2014Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeAnti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseBiological: infliximab and adalimumabRegionshospitalet Viborg, SkiveNULLCompleted18 YearsN/ABoth1035N/ANULL
108EUCTR2009-010065-23-DE
(EUCTR)
17/08/200914/04/2009Conventional 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: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System 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
109EUCTR2008-007519-34-SE
(EUCTR)
17/04/200902/03/2009Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSIONFeasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns withTrade Name: RemicadeUniversity of Leuven Hospitals, Division of GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Sweden
110NCT00791557
(ClinicalTrials.gov)
October 200813/11/2008Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel DiseaseAn Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma GangrenosumPyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseDrug: InfliximabUniversity Hospitals Cleveland Medical CenterCentocor, Inc.Completed18 Years75 YearsAll2N/AUnited States
111EUCTR2008-001968-36-GB
(EUCTR)
27/08/200815/07/2008Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCTComparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT Acute severe steroid resistant ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
Trade Name: Sandimmun
Trade Name: Neoral Soft Gelatin Capsules
Swansea UniversityNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
112EUCTR2006-002670-22-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
113EUCTR2006-005299-42-BE
(EUCTR)
20/05/200807/03/2008A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIFA randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: CICLOSPORIN
Other descriptive name: SANDINUM
INN or Proposed INN: CICLOSPORIN
Other descriptive name: NEORAL
Trade Name: CYCLOSPORIN
Trade Name: CYCLOSPORIN
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain
114EUCTR2006-005299-42-ES
(EUCTR)
19/05/200803/03/2008Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIFEstudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)Trade Name: Sandimmum
Product Name: ciclosporina
Trade Name: Remicade
Product Name: infliximab
GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain
115EUCTR2007-006692-37-GB
(EUCTR)
10/04/200825/01/2008 The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM
Imperial College LondonNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
116EUCTR2007-007702-30-IT
(EUCTR)
03/04/200808/07/2008Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - NDFeasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND Ulcerative colitis
MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: no
Male: yes
Italy
117EUCTR2006-005299-42-FI
(EUCTR)
25/02/200827/12/2007A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDYA randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti
INN or Proposed INN: CICLOSPORIN
Trade Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten
INN or Proposed INN: INFLIXIMAB
Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)NULLNot RecruitingFemale: yes
Male: yes
100France;Finland;Belgium;Spain
118EUCTR2006-002670-22-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
119EUCTR2006-002670-22-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
120EUCTR2006-000410-20-NL
(EUCTR)
13/11/200709/08/2007A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: RemicadeCentocor BVNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Netherlands;Belgium;Denmark;Italy
121EUCTR2006-002670-22-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
122EUCTR2006-002670-22-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
123EUCTR2006-002670-22-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
124EUCTR2006-002670-22-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
125EUCTR2006-002670-22-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
126EUCTR2006-000410-20-DK
(EUCTR)
13/08/200709/01/2007A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
INN or Proposed INN: infliximab
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
60Phase 3Netherlands;Belgium;Denmark;Italy
127EUCTR2006-002670-22-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
128EUCTR2006-000410-20-IT
(EUCTR)
02/08/200708/08/2007A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72 Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: REMICADE
INN or Proposed INN: Infliximab
CENTOCORNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Netherlands;Belgium;Denmark;Italy
129EUCTR2006-002670-22-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
130NCT00537316
(ClinicalTrials.gov)
July 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
131NCT00705484
(ClinicalTrials.gov)
June 1, 200723/6/2008European Safety Registry in Ulcerative Colitis (P04808)Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance ProgramUlcerative ColitisBiological: infliximab;Drug: Standard TherapyMerck Sharp & Dohme Corp.Centocor, Inc.Completed18 YearsN/AAll2239Austria;Belgium;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom;United States
132NCT00542152
(ClinicalTrials.gov)
June 20078/10/2007Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative ColitisA Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative ColitisUlcerative Colitis;Steroid RefractoryDrug: CYCLOSPORINE VS INFLIXIMABGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth115Phase 4Belgium;Finland;France;Italy;Spain
133NCT00606346
(ClinicalTrials.gov)
May 31, 200721/1/2008A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel DiseaseA Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel DiseasesBiological: Anti TNF therapy including infliximab;Drug: No BiologicsJanssen Biotech, Inc.NULLActive, not recruiting1 Month17 YearsAll4970United States;Canada
134EUCTR2006-005299-42-FR
(EUCTR)
16/05/200706/03/2007A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIFA randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: CICLOSPORIN
Other descriptive name: SANDINUM
INN or Proposed INN: CICLOSPORIN
Other descriptive name: NEORAL
Trade Name: CYCLOSPORIN
Trade Name: CYCLOSPORIN
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain
135EUCTR2006-000410-20-BE
(EUCTR)
18/04/200711/01/2007A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
INN or Proposed INN: infliximab
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Netherlands;Denmark;Belgium;Italy
136NCT00336492
(ClinicalTrials.gov)
September 20069/6/2006A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative ColitisA Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE?) in Pediatric Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisBiological: infliximabCentocor, Inc.NULLCompleted6 Years17 YearsAll60Phase 3United States;Belgium;Canada;Denmark;Netherlands
137NCT00207688
(ClinicalTrials.gov)
August 31, 200413/9/2005A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis PatientsA Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative ColitisUlcerative ColitisDrug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: PlaceboJanssen Research & Development, LLCJanssen Biologics BVCompletedN/AN/AAll505New Zealand;Switzerland;United Kingdom;Argentina;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Israel;Netherlands;United States;Czech Republic
138NCT00096655
(ClinicalTrials.gov)
May 200212/11/2004A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative ColitisA Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: InfliximabCentocor, Inc.NULLCompleted18 YearsN/ABoth364Phase 3NULL
139NCT00036439
(ClinicalTrials.gov)
February 200210/5/2002A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative ColitisA Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: InfliximabCentocor, Inc.NULLCompleted18 YearsN/ABoth364Phase 3United States;Belgium
140JPRN-JapicCTI-060298
24/08/2006Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitisClinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis Ulcerative colitisIntervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion
Mitsubishi Tanabe Pharma CorporationNULL16BOTHPhase 3NULL