96. Crohn disease
2,209 clinical trials,   1,276 drugs   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
2000 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
1NCT04151225
(ClinicalTrials.gov)
April 5, 20214/11/2019Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's DiseaseA Multicentre, Randomised, Double-blind, Placebo-controlled, Repeat Dose, Dose-ranging Phase 2a/2b Study to Evaluate the Safety, Tolerability and Efficacy of an Anti-oncostatin M Monoclonal Antibody (GSK2330811) in Patients With Moderate to Severe Crohn's DiseaseCrohns DiseaseDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLWithdrawn18 YearsN/AAll0Phase 2NULL
2NCT03870334
(ClinicalTrials.gov)
March 20218/3/2019Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseaseA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: BT-11 1,000 mg;Drug: PlaceboLandos Biopharma Inc.NULLNot yet recruiting18 Years75 YearsAll130Phase 2NULL
3NCT04118088
(ClinicalTrials.gov)
January 15, 20214/10/2019Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal FistulaCrohn's Disease;Complex Perianal FistulaBiological: DarvadstrocelMillennium Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll50Phase 4Austria;Czechia;France;Germany;Spain
4ChiCTR2000036845
2021-01-012020-08-25A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's diseaseA single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease Crohn's diseaseProctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ;Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineNULLPending1870BothProctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60;Phase 4China
5NCT04643483
(ClinicalTrials.gov)
January 202119/11/2020A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Certolizumab pegol;Drug: Adalimumab;Drug: PlaceboUCB Biopharma SRLNULLNot yet recruiting6 Years17 YearsAll150Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
6NCT03992469
(ClinicalTrials.gov)
January 202118/6/2019Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's DiseaseStudy to Evaluate Safety, Tolerability, and Early Efficacy of Oral B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's DiseaseCrohn's DiseaseDrug: BFAHF-2;Drug: PlaceboIcahn School of Medicine at Mount SinaiNULLNot yet recruiting18 Years30 YearsAll28Phase 1United States
7NCT04629196
(ClinicalTrials.gov)
January 202110/11/2020Induction Optimization With Stelara for Crohn's DiseaseInduction Optimization With Stelara for Crohn's DiseaseCrohn DiseaseDrug: UstekinumabNYU Langone HealthNULLNot yet recruiting18 Years70 YearsAll113Phase 4United States
8NCT04655807
(ClinicalTrials.gov)
December 16, 202030/11/2020A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: UstekinumabJanssen Research & Development, LLCNULLNot yet recruiting18 Years65 YearsAll70Phase 2United States;France;Germany;Italy;Spain;Sweden
9NCT03414788
(ClinicalTrials.gov)
December 7, 20208/1/2018Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's DiseasePHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTSInflammatory Bowel DiseaseBiological: PF 06687234;Biological: [124I]IB PF 06687234PfizerNULLWithdrawn18 Years75 YearsAll0Phase 1United States
10EUCTR2020-002674-26-GB
(EUCTR)
02/12/202026/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
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]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04660136
(ClinicalTrials.gov)
December 1, 20202/12/2020Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric PatientsUsefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric PatientsCrohn's Disease in Pediatric PatientBiological: contrast enhanced ultrasoundYonsei UniversityNULLRecruiting2 Years18 YearsAll20Phase 4Korea, Republic of
12NCT03747718
(ClinicalTrials.gov)
December 1, 20208/3/2018Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in ChildrenA Study for Evaluation of Clinical Response to Single vs. Maintenance Fecal Microbiota Transplantation in Pediatric Patients With Refractory Crohn's DiseaseCrohn DiseaseBiological: Fecal Microbiota Transplantation;Other: PlaceboStanford UniversityNULLNot yet recruiting2 Years25 YearsAll30Phase 1United States
13NCT04530877
(ClinicalTrials.gov)
December 1, 202024/8/2020Exclusive Enteral Nutrition vs. Infliximab in Chinese CD PatientsComparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's DiseaseCrohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal HealingBiological: Infliximab;Dietary Supplement: Exclusive Enteral NutritionChildren's Hospital of Fudan UniversityNULLNot yet recruiting1 Year18 YearsAll80Phase 4NULL
14NCT04073472
(ClinicalTrials.gov)
December 1, 202023/8/2019Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn'sA Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchCrohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, IleoanalDrug: mesenchymal stem cells (MSCs)The Cleveland ClinicNULLNot yet recruiting18 Years75 YearsAll15Phase 1United States
15NCT04263831
(ClinicalTrials.gov)
December 1, 20207/2/2020LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASELOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASECrohn DiseaseDrug: Interleukin-2 (aldesleukin).Boston Children's HospitalNULLNot yet recruiting18 Years80 YearsAll30Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04456517
(ClinicalTrials.gov)
December 202029/6/2020Reduce Crohn's-Associated Diarrhea With Sodium Channel TherapyREACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated DiarrheaCrohn's Disease;Inflammatory Bowel DiseaseDrug: Ranolazine;Drug: PlaceboVanderbilt University Medical CenterNULLNot yet recruiting18 YearsN/AAll16Phase 2United States
17EUCTR2020-002674-26-AT
(EUCTR)
23/11/202018/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
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]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
18NCT04519671
(ClinicalTrials.gov)
November 19, 202017/8/2020Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's DiseaseA Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's DiseasePerianal Crohn Disease;Perianal Fistula;Crohn DiseaseDrug: Mesenchymal Stem Cells;Other: PlaceboThe Cleveland ClinicNULLRecruiting18 Years75 YearsAll20Phase 1;Phase 2United States
19EUCTR2017-003090-34-DK
(EUCTR)
12/11/202015/06/2020A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Belgium;Austria;Denmark;Netherlands;Germany
20NCT04112212
(ClinicalTrials.gov)
November 4, 202025/9/2019NIR FME of Labelled Vedolizumab to Elucidate the Mechanism of Action and Predicting Response in IBD Patients.Near-infrared Fluorescence Molecular Endoscopy Imaging of Labelled Vedolizumab-800CW to Elucidate the Mechanism of Action and Predicting Response in IBD Patients. A Prospective Pilot Intervention Study:Crohn Disease;Colitis, UlcerativeDrug: Vedolizumab-800CW;Device: Fluorescence endoscopy and spectroscopyUniversity Medical Center GroningenNULLRecruiting18 YearsN/AAll35Phase 1Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2020-002674-26-NL
(EUCTR)
29/10/202015/09/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
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]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
22NCT04519697
(ClinicalTrials.gov)
October 28, 202017/8/2020Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's DiseaseA Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.Rectovaginal Fistula;Crohn Disease;Crohn Disease of Vulva;Rectolabial; FistulaDrug: Mesenchymal Stem Cells;Other: PlaceboThe Cleveland ClinicNULLRecruiting18 Years75 YearsFemale20Phase 1;Phase 2United States
23NCT04519684
(ClinicalTrials.gov)
October 28, 202017/8/2020Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's DiseaseA Phase IB/IIA Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchIleal Pouch;Crohn DiseaseDrug: Mesenchymal stem cells;Other: PlaceboThe Cleveland ClinicNULLRecruiting18 Years75 YearsAll20Phase 1;Phase 2United States
24NCT04535882
(ClinicalTrials.gov)
October 1, 202028/8/2020Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBDAssociation Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease ColitisLRG LevelsDiagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levelsShowa Inan General HospitalNULLRecruitingN/AN/AAll100Japan
25ChiCTR2000035737
2020-10-012020-08-16Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trialApplication of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial Crohn's diseaseExperimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience;Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of MedicineNULLPending1870BothExperimental group:45;Control group:45;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04276649
(ClinicalTrials.gov)
October 202017/2/2020Exploring the Effects of Caltrate Supplement on the Chronic Course of Ulcerative Colitis Patients With Vitamin D DeficiencyExploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort StudyUlcerative Colitis;Vitamin D Deficiency;Vitamin D SupplementDrug: Caltrate PillSecond Affiliated Hospital of Wenzhou Medical UniversityNULLNot yet recruitingN/AN/AAll60Early Phase 1China
27NCT04276636
(ClinicalTrials.gov)
October 202017/2/2020Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D DeficiencyExploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort StudyCrohn's Disease;Vitamin D Deficiency;Vitamin D SupplementDrug: Caltrate PillSecond Affiliated Hospital of Wenzhou Medical UniversityNULLNot yet recruitingN/AN/AAll60Early Phase 1China
28NCT04308850
(ClinicalTrials.gov)
October 202024/2/2020Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D DeficiencyExploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency,a Prospective Cohort StudyCrohn's Disease;Vitamin D Deficiency;Vitamin D SupplementDrug: Vitamin D dropsSecond Affiliated Hospital of Wenzhou Medical UniversityNULLNot yet recruitingN/AN/AAll60Early Phase 1China
29EUCTR2020-001811-26-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
30NCT04524611
(ClinicalTrials.gov)
September 30, 202020/8/2020Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF TherapyCrohn's Disease (CD)Drug: Risankizumab;Drug: UstekinumabAbbVieNULLRecruiting18 Years80 YearsAll517Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04223518
(ClinicalTrials.gov)
September 20, 20206/1/2020Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel DiseaseInflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: PlaceboMonisha Hitesh ShahNULLRecruiting6 Years30 YearsAll43Early Phase 1United States
32EUCTR2018-004614-18-DK
(EUCTR)
08/09/202005/08/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
33ChiCTR2000037094
2020-09-012020-08-26Discovery and detection of a novel antigen for Crohn’s disease (CD)Discovery and detection of a novel antigen for Crohn’s disease (CD) Inflammatory Bowel DiseaseGold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA;The First Affiliated Hospital of Anhui Medical UniversityNULLCompleted1880BothTarget condition:100;Difficult condition:100China
34NCT04398836
(ClinicalTrials.gov)
September 202018/7/2019Preoperative Nutrition for Crohn's Disease PatientsPreoperative Nutrition for Crohn's Disease PatientsMalnutrition;Crohn DiseaseDietary Supplement: Exclusive Enteral Nutrition;Other: High energy / protein diet.;Other: Standard nutritionTel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years70 YearsAll144Phase 3Israel
35NCT04331639
(ClinicalTrials.gov)
September 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 HospitalNULLNot yet recruiting5 Years25 YearsAll50Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04502303
(ClinicalTrials.gov)
September 20204/8/202018F-FDG and 68Ga-FAPI PET/CT in Crohn's DiseaseA Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CTCrohn DiseaseDiagnostic Test: 18F-FDG and 68Ga-FAPI PET/CTPeking Union Medical College HospitalNULLNot yet recruiting18 YearsN/AAll30Phase 2NULL
37EUCTR2018-004614-18-HR
(EUCTR)
24/08/202023/11/2020Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
38EUCTR2017-002491-10-AT
(EUCTR)
19/08/202011/05/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
39EUCTR2019-002895-14-GB
(EUCTR)
05/08/202002/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202 Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Slovenia;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China
40EUCTR2019-002895-14-NL
(EUCTR)
05/08/202023/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03943446
(ClinicalTrials.gov)
August 4, 20207/5/2019TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD)A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease RecurrenceCrohn DiseaseDrug: TAK-018;Drug: TAK-018 PlaceboMillennium Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll96Phase 2United States;Austria;France;Germany;United Kingdom;Netherlands
42NCT04362735
(ClinicalTrials.gov)
August 1, 202019/4/2020Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological TherapyEfficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world StudyCrohn DiseaseDrug: VedolizumabPontifícia Universidade Católica do ParanáTakedaNot yet recruiting18 YearsN/AAll100NULL
43EUCTR2019-002895-14-PT
(EUCTR)
27/07/202006/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
44EUCTR2017-002491-10-FR
(EUCTR)
17/07/202009/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
45NCT04312659
(ClinicalTrials.gov)
July 15, 20203/3/2020A Study of Infliximab in the Treatment of Chinese Children With Crohn's DiseaseA Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's DiseaseCrohn DiseaseDrug: InfliximabJohnson & Johnson (China) Investment Ltd.NULLRecruiting6 Years17 YearsAll40China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2019-001673-93-HU
(EUCTR)
07/07/202009/06/2020A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of
47NCT03935451
(ClinicalTrials.gov)
July 1, 202023/4/2019Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel DiseaseA Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot StudyIBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal DisordersDrug: Apixaban 2.5 milligram;Drug: Placebo Oral TabletMcMaster UniversityNULLNot yet recruiting18 YearsN/AAll60Early Phase 1NULL
48EUCTR2019-003335-37-DE
(EUCTR)
29/06/202027/11/2019A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: JNJ-67864238
Product Code: JNJ-67864238
INN or Proposed INN: Not available
Other descriptive name: PTG-200
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2United States;Argentina;Poland;Russian Federation;Germany;Italy
49EUCTR2017-001240-35-FR
(EUCTR)
22/06/202009/03/2020A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
50NCT04232553
(ClinicalTrials.gov)
June 22, 202015/1/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's DiseaseCrohn's DiseaseDrug: MirikizumabEli Lilly and CompanyNULLRecruiting18 YearsN/AAll778Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Romania;Russian Federation;Spain;Turkey;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2017-002491-10-DE
(EUCTR)
22/06/202009/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom
52NCT04163016
(ClinicalTrials.gov)
June 19, 202024/10/2019A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque PsoriasisDrug: Pharmacokinetics of certolizumab pegolUCB Biopharma S.P.R.L.NULLRecruiting18 YearsN/AFemale20Phase 1United States;Canada;Switzerland
53EUCTR2018-004346-42-AT
(EUCTR)
18/06/202021/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
54NCT04397263
(ClinicalTrials.gov)
June 10, 202018/5/2020A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohns DiseaseDrug: GuselkumabJanssen Pharmaceutical K.K.NULLRecruiting18 YearsN/AAll25Phase 3Japan
55JPRN-JapicCTI-205298
10/6/202026/05/2020A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease Crohn's DiseaseIntervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Janssen Pharmaceutical K.K.NULLpending18BOTH25Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-004346-42-BG
(EUCTR)
28/05/202008/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
57EUCTR2019-002687-27-NL
(EUCTR)
28/05/202018/05/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
58EUCTR2019-002895-14-BG
(EUCTR)
21/05/202023/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
59EUCTR2018-004614-18-LT
(EUCTR)
20/05/202025/11/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
60EUCTR2019-001673-93-DE
(EUCTR)
19/05/202002/03/2020A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolilmab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT04362254
(ClinicalTrials.gov)
May 15, 202023/4/2020A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous TrialsAn Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Fistulising Crohn's Disease Who Have Completed Previous Spesolimab TrialsCrohn DiseaseDrug: SpesolimabBoehringer IngelheimNULLRecruiting18 YearsN/AAll20Phase 2Austria;Germany
62NCT04372108
(ClinicalTrials.gov)
May 14, 202030/4/2020A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's DiseaseAn Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records DatabaseCrohn DiseaseDrug: Ustekinumab;Drug: Other Biologic TherapiesJanssen Scientific Affairs, LLCNULLRecruiting18 YearsN/AAll1536United States
63EUCTR2019-002895-14-ES
(EUCTR)
14/05/202015/05/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
64EUCTR2019-000176-41-HU
(EUCTR)
07/05/202016/03/2020A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment Crohn's Disease
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]
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy
65EUCTR2019-000886-19-AT
(EUCTR)
06/05/202006/09/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
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]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2019-000333-39-BE
(EUCTR)
04/05/202021/01/2020Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
67EUCTR2019-002895-14-NO
(EUCTR)
04/05/202020/12/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;Belarus;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
68ChiCTR2000031344
2020-05-012020-03-28Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical studyEndoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study Crohn's diseaseGroup 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection;The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of MedicineNULLPendingBothGroup 1:35;Group 2:35;China
69EUCTR2019-002687-27-HU
(EUCTR)
28/04/202009/03/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
70EUCTR2019-004219-29-NL
(EUCTR)
21/04/202004/02/2020Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s DiseasePersonalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Azithromycin
Product Name: Azithromycin
INN or Proposed INN: Azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: METRONIDAZOLE
Amsterdam UMCNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Canada;Israel;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2018-004346-42-BE
(EUCTR)
15/04/202003/03/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
72NCT03905109
(ClinicalTrials.gov)
April 15, 20203/4/2019Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's DiseaseA Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid TreatmentCrohn DiseaseDrug: ABX464;Drug: PlaceboAbivax S.A.NULLNot yet recruiting18 Years75 YearsAll30Phase 2Belgium
73NCT04225819
(ClinicalTrials.gov)
April 1, 20203/1/2020Adjunctive Treatment With Vitamin D3 in Patients With Active IBDAdjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled TrialIBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 DeficiencyDietary Supplement: Vitamin D3;Other: PlaceboMassachusetts General HospitalNULLNot yet recruiting18 YearsN/AAll100N/ANULL
74EUCTR2018-004346-42-HU
(EUCTR)
25/03/202031/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
75EUCTR2018-004346-42-CZ
(EUCTR)
24/03/202022/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2019-001337-13-FR
(EUCTR)
18/03/202002/03/2020USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD studyUSTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: STELARA
Trade Name: STELARA 90 mg solution for injection in pre-filled syringe
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
146Phase 4France
77EUCTR2018-002629-51-GB
(EUCTR)
16/03/202008/01/2020A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
78EUCTR2017-002491-10-CZ
(EUCTR)
10/03/202027/11/2019Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
79NCT03492944
(ClinicalTrials.gov)
March 6, 202012/2/2018Contrast Enhanced Ultrasound in Human Crohn's Disease-LumasonContrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI EnterographyCrohn DiseaseDrug: Ultrasound Microbubble Contrast Agent;Device: Ultrasound ImagingChildren's Hospital Medical Center, CincinnatiNULLRecruiting10 Years18 YearsAll25United States
80EUCTR2019-000886-19-NL
(EUCTR)
06/03/202017/09/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
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]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2017-001976-48-FR
(EUCTR)
06/03/202009/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Portugal;Taiwan;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;China;Japan;Korea, Republic of
82NCT04188990
(ClinicalTrials.gov)
March 5, 20202/12/2019Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related MalnutritionEvaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related MalnutritionPancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal CancerDietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current careHospital Galdakao-UsansoloNULLNot yet recruiting18 YearsN/AAll900N/ANULL
83NCT04014517
(ClinicalTrials.gov)
March 1, 20208/7/2019Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease PatientsEffect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease PatientsCrohn DiseaseOther: Standard of Care;Dietary Supplement: ImmunonutritionIstituto Clinico HumanitasNULLNot yet recruiting18 YearsN/AAll350N/ANULL
84ChiCTR2000029323
2020-03-012020-01-25Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trialLaparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial Crohn's diseaseExperimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab;Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityNULLPending1880BothExperimental group:30;Control group:30;China
85EUCTR2019-002895-14-SK
(EUCTR)
26/02/202010/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2018-004614-18-LV
(EUCTR)
19/02/202012/12/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
87EUCTR2019-002895-14-FR
(EUCTR)
17/02/202008/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States
88NCT04254783
(ClinicalTrials.gov)
February 16, 20203/2/2020A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseA Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis (UC);Crohn's DiseaseDrug: Risankizumab;Drug: Cytochrome P450 (CYP) SubstratesAbbVieNULLRecruiting18 Years80 YearsAll20Phase 1United States;Germany;Israel
89EUCTR2019-002895-14-LT
(EUCTR)
13/02/202019/12/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
90NCT04173273
(ClinicalTrials.gov)
February 12, 202020/11/2019A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLRecruiting18 Years80 YearsAll1265Phase 2;Phase 3United States;Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2019-000176-41-IT
(EUCTR)
11/02/202005/11/2020A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment - - Crohn's Disease
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]
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Otsuka Pharmaceutical Development and Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Belgium;Germany;Italy
92ChiCTR2000029543
2020-02-082020-02-03A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's DiseaseA Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease Crohn's DiseaseGold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines;The First Hospital Affiliated to Sun Yat sen UniversityNULLRecruitingBothTarget condition:350;Difficult condition:0China
93NCT03999580
(ClinicalTrials.gov)
February 7, 202024/6/2019The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in ChildrenCrohn DiseaseDrug: vitamin D3Jantchou PrevostNULLRecruiting4 Years18 YearsAll316Phase 3Canada
94EUCTR2019-001673-93-AT
(EUCTR)
05/02/202013/12/2019A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
95NCT03950336
(ClinicalTrials.gov)
February 4, 202013/5/2019Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease PatientsInfluence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's PatientsHealthy First Degree Relatives of Crohn's Disease PatientsDietary Supplement: Prebiotics;Other: Low n-6 PUFA Diet;Dietary Supplement: Maltodextrin;Other: Control DietUniversity of AlbertaNULLRecruiting15 Years50 YearsAll32N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2019-002895-14-HU
(EUCTR)
03/02/202004/02/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Switzerland;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
97NCT03961815
(ClinicalTrials.gov)
February 3, 20208/5/2019Open-label Extension Study of Brazikumab in Crohn's DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: BrazikumabAllerganNULLEnrolling by invitation16 Years80 YearsAll1000Phase 3United States
98EUCTR2019-000852-32-NL
(EUCTR)
30/01/202008/10/2019A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study Inflammatory Bowel Disease, Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Naltrexone hydrochlorideErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
122Phase 2Netherlands
99EUCTR2019-000886-19-FR
(EUCTR)
20/01/202026/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
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]
Millennium Pharmaceuticals, Inc (a wholly owned subsidiaryNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75Phase 2United States;France;Germany;United Kingdom
100EUCTR2019-000176-41-PL
(EUCTR)
17/01/202006/09/2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment Crohn's Disease
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]
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240Phase 2United States;Canada;Belgium;Poland;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2019-002895-14-GR
(EUCTR)
14/01/202003/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
102EUCTR2019-002895-14-CZ
(EUCTR)
09/01/202009/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
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]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
103NCT04224558
(ClinicalTrials.gov)
January 1, 20204/4/2018Stem Cell Transplantation in Crohn's DiseaseAutologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's DiseaseCrohn DiseaseDrug: Mesna;Drug: Cyclophosphamide;Drug: Filgrastim;Procedure: Apheresis catheter placement;Procedure: Leukapheresis;Drug: Fludarabine;Drug: Methylprednisolone;Drug: Diphenhydramine;Drug: Acetaminophen;Drug: anti-thymocyte globulin (rabbit);Drug: lymphocyte immune globulin;Biological: Peripheral Blood Stem Cell Infusion;Drug: CytoxanCedars-Sinai Medical CenterNULLNot yet recruiting16 Years24 YearsAll15Phase 1;Phase 2United States
104NCT04239248
(ClinicalTrials.gov)
January 202027/11/2019Tasty&Healthy Dietary Approach for Crohn's DiseaseTasty&Healthy is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's DiseaseCrohn DiseaseDietary Supplement: Tasty&Healthy intervention group;Dietary Supplement: EEN intervention groupShaare Zedek Medical CenterNULLNot yet recruiting6 Years24 YearsAll192N/AIsrael
105NCT04233463
(ClinicalTrials.gov)
January 202015/1/2020The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's DiseaseThe Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized StudyCrohn DiseaseDietary Supplement: Modulen;Drug: BudesonideHillel Yaffe Medical CenterNULLNot yet recruiting18 Years70 YearsAll50N/AIsrael
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2018-004346-42-ES
(EUCTR)
26/12/201911/11/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2000Phase 2;Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden
107EUCTR2019-003662-40-DE
(EUCTR)
18/12/201922/10/2019Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED
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: Amgevita 40 mg Injektionslösung in einer Fertigspritze
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen
INN or Proposed INN: ADALIMUMAB
Universitätsklinikum ErlangenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
82Phase 4Germany
108EUCTR2019-003816-29-FR
(EUCTR)
16/12/201914/10/2019Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawalFecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal - MIRACLE Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors
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]
ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200Phase 3France
109EUCTR2018-005086-39-HR
(EUCTR)
16/12/201917/01/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
110EUCTR2017-001976-48-PT
(EUCTR)
16/12/201922/05/2019A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
144Phase 2Portugal;United States;Taiwan;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;Japan;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2018-004346-42-DE
(EUCTR)
10/12/201917/06/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
112NCT03915262
(ClinicalTrials.gov)
December 2, 20199/4/2019Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's DiseaseExocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological TherapyCrohn DiseaseBiological: Search for exocrine pancreatic insufficiency at week 0 and 12Hospices Civils de LyonNULLRecruiting18 YearsN/AAll50France
113EUCTR2017-004294-14-FR
(EUCTR)
02/12/201909/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
114NCT04134065
(ClinicalTrials.gov)
December 1, 201917/10/2019the Effect of Vitamin D in Crohn's Diseasethe Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's DiseaseVitamin D Deficiency;Crohn DiseaseDrug: Vitamin D;Drug: Placebo oral capsuleNanjing University School of MedicineShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityNot yet recruiting20 Years60 YearsAll30Early Phase 1NULL
115NCT02677350
(ClinicalTrials.gov)
December 1, 20191/2/2016AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)A Phase I, Pilot Trial to Evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn's Disease.Crohn's Disease;Fistulizing Crohn's Disease;Stem CellsDrug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)Joshua M HareNULLWithdrawn18 YearsN/AAll0Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2019-001087-30-AT
(EUCTR)
28/11/201912/09/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan
117EUCTR2017-001240-35-SI
(EUCTR)
27/11/201912/11/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
118EUCTR2019-000886-19-DE
(EUCTR)
26/11/201929/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
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]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (A wholly owned subsidiary of Takeda Pharmaceutical Company Limited)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Netherlands;Germany;United Kingdom
119EUCTR2018-001895-39-HR
(EUCTR)
21/11/201920/01/2020A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 2Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
120EUCTR2019-003068-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-002629-51-AT
(EUCTR)
12/11/201927/06/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
122EUCTR2017-004293-33-FR
(EUCTR)
12/11/201909/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
123EUCTR2019-001087-30-HR
(EUCTR)
11/11/201917/01/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
124ChiCTR1900027370
2019-11-112019-11-10The pathogenic genes and flora of Crohn's disease with anal fistulaThe pathogenic genes and flora of Crohn's disease with anal fistula Crohn's disease with anal fistulaCD anal fistula and CD without anal fistula:N/A;Nanfang Hospital, Southern Medical UniversityNULLRecruitingBothCD anal fistula and CD without anal fistula:50;N/AChina
125EUCTR2019-000886-19-GB
(EUCTR)
06/11/201929/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence - TAK-018 for Prevention of the Recurrence of Postoperative Crohn’s Disease Crohn’s Disease
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]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiaryNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2017-004292-31-FR
(EUCTR)
05/11/201909/08/2019Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
127EUCTR2018-004346-42-FR
(EUCTR)
05/11/201910/07/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2000Phase 2;Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden
128NCT04075825
(ClinicalTrials.gov)
November 4, 201922/8/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II StudyCrohn's Disease;Complex Perianal FistulaBiological: DarvadstrocelMillennium Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll150Phase 3United States;Belgium;Czechia;France;Hungary;Israel;Italy;Poland;Spain
129NCT04154735
(ClinicalTrials.gov)
November 20198/3/2019Autologous Transplant Targeted Against Crohn'sAutologous Hematopoietic Stem Cell Transplant for Crohn's DiseaseCrohn's DiseaseDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: TacrolimusNorthwestern UniversityNULLWithdrawn18 Years49 YearsAll0Phase 2United States
130EUCTR2019-001087-30-DE
(EUCTR)
31/10/201901/07/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2019-001087-30-BG
(EUCTR)
30/10/201924/10/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
132EUCTR2018-005086-39-HU
(EUCTR)
28/10/201908/04/2019A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested
Landos Biopharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
133NCT03945019
(ClinicalTrials.gov)
October 28, 20198/5/2019CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's DiseaseA 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 Crohn's DiseaseCrohn's DiseaseBiological: CT-P13 SC (Infliximab);Other: Placebo SCCelltrionNULLRecruiting18 Years75 YearsAll600Phase 3United States
134NCT03962998
(ClinicalTrials.gov)
October 27, 201922/5/2019Oral Administration of MB-102 Versus Dual Sugar Testing for Gut PermeabilityA Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's DiseaseCrohn DiseaseDrug: Lactulose/Rhamnose solution;Drug: MB-102MediBeaconNULLRecruiting18 YearsN/AAll20Early Phase 1United States
135EUCTR2019-002093-32-SE
(EUCTR)
24/10/201928/06/2019A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease. None. Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial. Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated.
MedDRA version: 20.1;Level: LLT;Classification code 10011603;Term: CT scan;System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Lument ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2018-004614-18-NL
(EUCTR)
21/10/201927/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
137EUCTR2019-000333-39-CZ
(EUCTR)
15/10/201903/09/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
138EUCTR2018-004614-18-DE
(EUCTR)
15/10/201925/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
139EUCTR2017-004295-55-FR
(EUCTR)
08/10/201909/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
140EUCTR2018-005086-39-PL
(EUCTR)
07/10/201906/05/2019A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT04131322
(ClinicalTrials.gov)
October 201910/10/2019Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH StudyCrohn Disease;Ulcerative ColitisDrug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for InjectionFundación Pública Andaluza para la gestión de la Investigación en SevillaNULLNot yet recruiting18 YearsN/AAll216Phase 4NULL
142EUCTR2018-001895-39-NL
(EUCTR)
27/09/201903/06/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 2Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany
143NCT04102111
(ClinicalTrials.gov)
September 23, 201923/9/2019A Study Evaluating Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-67864238;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll90Phase 2United States;Argentina;France;Germany;Italy;Poland;Russian Federation;Ukraine
144ChiCTR1900026091
2019-09-192019-09-20Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's diseaseDevelopment of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study Crohn's diseaseCase series:infliximab;The First Affiliated Hospital of Sun Yat-sen UniversityNULLPending958BothCase series:343;China
145EUCTR2018-004614-18-GB
(EUCTR)
16/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2018-004614-18-ES
(EUCTR)
12/09/201904/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 Moderately to severely active Crohn’s disease
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]
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
147EUCTR2018-004614-18-FR
(EUCTR)
11/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
148EUCTR2018-004346-42-GB
(EUCTR)
10/09/201930/05/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
149EUCTR2017-004588-11-NL
(EUCTR)
10/09/201910/09/2019Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial The Chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Maastricht University Medical CentreNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
146Phase 4Netherlands
150NCT03885713
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2019-001087-30-PL
(EUCTR)
09/09/201924/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
152EUCTR2018-001895-39-BG
(EUCTR)
05/09/201916/07/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 2Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
153EUCTR2019-001948-21-FR
(EUCTR)
03/09/201915/05/2019Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas.Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas. - ADICROHN-II Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: autologous ADIpose derived stromal vascular fraction
Product Code: ADSVF
Trade Name: vialebex 200mg
Product Name: VIALEBEX
Product Code: SERUM ALBUMINE 5%
INN or Proposed INN: ALBUMINE HUMAINE
Other descriptive name: HUMAN ALBUMIN AS MACROAGGREGATES
Trade Name: serum physiologique 0.9 %
Product Name: chlorure de sodium
INN or Proposed INN: CHLORURE DE SODIUM
Other descriptive name: SODIUM CHLORIDE
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2France
154EUCTR2018-004614-18-PL
(EUCTR)
03/09/201909/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
155EUCTR2019-001087-30-GR
(EUCTR)
28/08/201926/07/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2019-001087-30-ES
(EUCTR)
14/08/201910/09/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
157EUCTR2019-001087-30-FR
(EUCTR)
13/08/201914/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
158EUCTR2019-001087-30-HU
(EUCTR)
09/08/201910/08/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
159EUCTR2019-001087-30-CZ
(EUCTR)
06/08/201906/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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: REMSINA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
160EUCTR2018-002629-51-FR
(EUCTR)
31/07/201924/04/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200Phase 3United States;France;Spain;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2019-001087-30-LV
(EUCTR)
25/07/201904/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA 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 Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
162EUCTR2018-004614-18-HU
(EUCTR)
25/07/201911/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
163NCT03926130
(ClinicalTrials.gov)
July 23, 201923/4/2019A Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Mirikizumab;Drug: Ustekinumab;Drug: PlaceboEli Lilly and CompanyNULLRecruiting15 Years80 YearsAll1150Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
164EUCTR2016-003191-50-FR
(EUCTR)
17/07/201928/01/2019A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
959Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
165EUCTR2017-000725-12-DE
(EUCTR)
17/07/201928/02/2019A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2017-001226-18-SI
(EUCTR)
15/07/201906/03/2019A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
167NCT04056442
(ClinicalTrials.gov)
July 7, 201913/8/2019A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease PatientsA Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease PatientsSteroid Dependent Crohn's DiseaseDrug: Cannabidiol , synthetic form;Drug: PlaceboStero Biotechs Ltd.NULLRecruiting18 YearsN/AAll28Phase 2Israel
168NCT03914261
(ClinicalTrials.gov)
July 1, 201911/4/2019Expanded Access to RisankizumabExpanded Access to RisankizumabCrohn's Disease;Ulcerative Colitis (UC)Drug: RisankizumabAbbVieNULLAvailable18 YearsN/AAllBelgium;Israel;Spain;Switzerland;United States
169NCT04002180
(ClinicalTrials.gov)
July 1, 201926/6/2019Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]Crohn's DiseaseDrug: Vedolizumab (Genetical Recombination)TakedaNULLRecruitingN/AN/AAll300Japan
170ChiCTR1900023696
2019-07-012019-06-08Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trialEndoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial Chron's diseaseGroup 1:EBD;Group 2:EBD combined with local injection of betamethasone;The Sixth Affiliated Hospital of Sun Yat-sen UniversityNULLPending1875BothGroup 1:45;Group 2:45;N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171JPRN-JapicCTI-194830
01/7/201927/06/2019Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] Crohn's diseaseIntervention name : Vedolizumab (Genetical Recombination)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLpendingBOTH300NAJapan
172NCT04089514
(ClinicalTrials.gov)
June 30, 201912/9/2019A Real-world Study of Imraldi® UsePan-EU Real-World Experience With Imraldi®Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC)Drug: AdalimumabBiogenNULLRecruiting18 YearsN/AAll1400Germany;United Kingdom
173EUCTR2019-000717-37-ES
(EUCTR)
27/06/201928/06/2019Loss of response of the Adalimumba biosimilar compared with the original drug LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY. ADA-SWITCH Study - ADA-SWITCH Study Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
136Phase 4Spain
174EUCTR2019-002038-35-BE
(EUCTR)
27/06/201907/06/2019A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patientsA prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST Crohn's disease
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: Stelara
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
UZ LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Belgium
175EUCTR2017-004997-32-DE
(EUCTR)
25/06/201914/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT04254549
(ClinicalTrials.gov)
June 14, 20193/2/2020Rifaximin in Patients With Diabetic GastroparesisEvaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.Crohn Disease;Diabetic GastroparesisDrug: Rifaximin;Drug: PlaceboMayo ClinicNULLRecruiting18 Years75 YearsAll40Phase 2United States
177EUCTR2017-002195-13-GB
(EUCTR)
05/06/201928/02/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
178NCT03941418
(ClinicalTrials.gov)
June 1, 20195/5/2019Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseImpact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseUlcerative Colitis;Crohn DiseaseDietary Supplement: Boulardii;Dietary Supplement: PlaceboUniversity Clinic Dr Dragisa Misovic-DedinjeUniversity Clinic ZvezdaraNot yet recruiting18 Years80 YearsAll150N/ANULL
179NCT03677648
(ClinicalTrials.gov)
May 14, 201917/9/2018A Phase II Study in Patients With Moderate to Severe Active Crohn's DiseaseA Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseDrug: SHR0302;Drug: PlacebosReistone Biopharma Company LimitedNULLRecruiting18 Years75 YearsAll144Phase 2United States;China;Poland;Ukraine
180EUCTR2017-003090-34-HU
(EUCTR)
10/05/201925/03/2019A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
28Phase 2Hungary;Belgium;Austria;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2016-003190-17-FR
(EUCTR)
07/05/201914/03/2019A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
182ChiCTR1900022728
2019-05-012019-04-23Cohort study combined with omics screening for the early diagnostic markers in Crohn's diseaseCohort study combined with omics screening for the early diagnostic markers in Crohn's disease Crohn's diseaseGold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD;The 7th Medical Center of the PLA General Hospital (Army general hospital)NULLPendingBothTarget condition:310;Difficult condition:160China
183EUCTR2018-004967-30-GB
(EUCTR)
30/04/201914/01/2019Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over StudyIBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imraldi
Product Name: Imraldi
INN or Proposed INN: adalimumab
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab
University Hospital Southampton NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United Kingdom
184EUCTR2018-003594-95-NL
(EUCTR)
30/04/201930/04/2019Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapyMethotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response Inflammatory bowel disease: Crohn's disease and Ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Amsterdam UMC location AMCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 4Netherlands
185NCT03733314
(ClinicalTrials.gov)
April 25, 20195/11/2018A Study of E6011 in Participants With Active Crohn's DiseaseEarly Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: E6011;Drug: PlaceboEA Pharma Co., Ltd.NULLRecruiting18 Years64 YearsAll40Phase 2Czechia;Hungary;Japan;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2018-002629-51-SE
(EUCTR)
23/04/201929/01/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;France;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
187EUCTR2017-001225-41-SI
(EUCTR)
19/04/201906/03/2019A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
188EUCTR2017-000725-12-GB
(EUCTR)
17/04/201922/10/2018A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom
189EUCTR2017-003090-34-NL
(EUCTR)
16/04/201919/12/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of
190EUCTR2017-001976-48-DK
(EUCTR)
15/04/201929/01/2019A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Bouvet Island;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2018-002109-70-HU
(EUCTR)
15/04/201920/11/2018A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel diseaseEarly phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable Active Crohn’s disease
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]
EA Pharma Co., Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 2Czech Republic;Hungary;Poland;Japan
192EUCTR2018-002064-15-NL
(EUCTR)
15/04/201915/04/2019Patient preference model: treatment of perianal fistulas in Crohn's diseaseTreatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Product Name: Infliximab
Trade Name: Humira
Product Name: Adalimumab
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
140Phase 4Netherlands
193NCT03942120
(ClinicalTrials.gov)
April 8, 20197/5/2019Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARACrohn DiseaseDrug: UstekinumabJanssen Korea, Ltd., KoreaNULLRecruiting18 YearsN/AAll70Korea, Republic of
194EUCTR2018-001272-37-HR
(EUCTR)
05/04/201917/05/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
195NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll264Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03712826
(ClinicalTrials.gov)
April 201916/8/2018Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's DiseaseIdentification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's DiseaseCrohn DiseaseDrug: Anti-TNF Drug;Drug: UstekinumabHospices Civils de LyonNULLRecruiting18 YearsN/AAll60N/AFrance
197NCT03884439
(ClinicalTrials.gov)
March 18, 20194/3/2019Infliximab Biosimilar Pfizer Drug Use 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
198EUCTR2017-002195-13-PT
(EUCTR)
18/03/201923/07/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
199EUCTR2018-003303-19-PL
(EUCTR)
15/03/201923/01/2019A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease. Crohn’s Disease
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]
Reistone Biopharma Company LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
144Phase 2United States;Poland;Ukraine;China
200EUCTR2017-001226-18-IE
(EUCTR)
08/03/201905/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2017-001225-41-IE
(EUCTR)
08/03/201913/03/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
202EUCTR2017-001240-35-IE
(EUCTR)
08/03/201905/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
203NCT03706456
(ClinicalTrials.gov)
March 6, 201911/10/2018Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's DiseaseComplex Perianal Fistulas in Adult Patients With Crohn's DiseaseBiological: DarvadstrocelTakedaNULLActive, not recruiting18 YearsN/AAll22Phase 3Japan
204NCT03901937
(ClinicalTrials.gov)
March 1, 201912/3/2019The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's DiseaseDepartment of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, ChinaCrohn DiseaseDrug: ?-3 polyunsaturated fatty acid;Procedure: Intestinal surgery for Crohn's DiseaseSir Run Run Shaw HospitalNULLRecruiting18 Years75 YearsAll158Phase 4China
205EUCTR2017-000575-88-GB
(EUCTR)
28/02/201911/04/2018 Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1032Phase 3Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2017-000617-23-GB
(EUCTR)
28/02/201911/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
983Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
207EUCTR2017-000574-11-GR
(EUCTR)
26/02/201927/11/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s 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]
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
208EUCTR2017-000617-23-GR
(EUCTR)
26/02/201921/02/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
209EUCTR2017-000576-29-GR
(EUCTR)
26/02/201925/02/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
210EUCTR2018-001272-37-AT
(EUCTR)
25/02/201921/09/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2018-001272-37-PT
(EUCTR)
25/02/201930/07/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160Phase 2Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
212EUCTR2017-003090-34-DE
(EUCTR)
18/02/201915/11/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Denmark;Austria
213EUCTR2016-005199-90-SK
(EUCTR)
14/02/201914/02/2018Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study - RHB-104-04 and MAP (US2) Moderately to Severely Active Crohn's Disease
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]
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
100Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Australia;Israel;New Zealand
214NCT03681652
(ClinicalTrials.gov)
February 11, 201920/9/2018Post-Operative Crohn's Disease Outcome in ChildrenPost-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open StudyCrohn DiseaseDrug: Azathioprine;Drug: Anti-TNF DrugSchneider Children's Medical Center, IsraelNULLRecruiting6 Years18 YearsAll100Israel
215NCT03627091
(ClinicalTrials.gov)
February 6, 201924/7/2018Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)Crohn's DiseaseDrug: Ontamalimab;Other: PlaceboShireNULLActive, not recruiting16 Years80 YearsAll40Phase 3Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;United States;Australia;Argentina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2017-003090-34-AT
(EUCTR)
05/02/201911/10/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
217NCT03752970
(ClinicalTrials.gov)
February 5, 201922/11/2018A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's DiseaseCrohn DiseaseDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLRecruiting18 Years75 YearsAll28Phase 2Austria;Belgium;Germany;Hungary;Korea, Republic of;Netherlands;Spain
218EUCTR2017-004997-32-HU
(EUCTR)
04/02/201904/04/2019A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
219EUCTR2017-004295-55-PT
(EUCTR)
04/02/201901/10/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
220EUCTR2017-004997-32-NL
(EUCTR)
30/01/201906/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2016-000634-21-FR
(EUCTR)
28/01/201908/11/2018 A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
222NCT03650413
(ClinicalTrials.gov)
January 14, 201916/8/2018An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: UTTR1147AGenentech, Inc.NULLRecruiting18 Years80 YearsAll320Phase 2United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France
223EUCTR2017-000617-23-HR
(EUCTR)
11/01/201916/05/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
224EUCTR2017-000575-88-HR
(EUCTR)
11/01/201916/05/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Serbia;Czechia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
225EUCTR2018-001272-37-FR
(EUCTR)
10/01/201923/07/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160Phase 2Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2018-002629-51-NL
(EUCTR)
08/01/201912/11/2018A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
227EUCTR2017-004997-32-GB
(EUCTR)
04/01/201909/10/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
228NCT04606017
(ClinicalTrials.gov)
January 1, 201925/10/2020Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response in Patients With Crohn's DiseaseEffect of Vitamin D Combined With Calcium Supplementation on Infliximab ResponseCrohn Disease;Vitamin D Deficiency;Vitamin D SupplementDrug: Caltrate PillSecond Affiliated Hospital of Wenzhou Medical UniversityNULLCompletedN/AN/AAll70China
229NCT03773237
(ClinicalTrials.gov)
December 31, 201812/11/2018Intralipid Versus SMOFlipid in HPN PatientsRandomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.Short Bowel Syndrome;Intestinal Fistula;Crohn Disease;Intestinal ObstructionDietary Supplement: SMOFLipid;Dietary Supplement: IntralipidMayo ClinicNULLRecruiting18 Years75 YearsAll100N/AUnited States
230EUCTR2017-001225-41-HR
(EUCTR)
31/12/201821/05/2019A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2018-002925-47-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]
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 4Spain
232EUCTR2017-001240-35-HR
(EUCTR)
20/12/201821/05/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
233EUCTR2017-001976-48-DE
(EUCTR)
20/12/201822/08/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Czechia;Taiwan;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
234NCT03782376
(ClinicalTrials.gov)
December 20, 201811/12/2018A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab approximately 6 mg/kg (IV);Drug: Placebo (SC);Drug: Placebo (IV);Drug: Ustekinumab 90 mg (SC) Group 1;Drug: Ustekinumab 90 mg (SC) Group 2Janssen-Cilag Ltd.NULLRecruiting18 YearsN/AAll200Phase 3United States;Austria;France;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
235EUCTR2017-001226-18-HR
(EUCTR)
19/12/201821/05/2019A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236ChiCTR1800019958
2018-12-162018-12-09Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's DiseaseCombining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease Crohn's diseaseCase series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;Daping Hospital, Army Medical University (Third Military Medical University)NULLRecruiting1865BothCase series:60;China
237EUCTR2017-004997-32-IE
(EUCTR)
14/12/201813/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
238EUCTR2017-004295-55-BE
(EUCTR)
13/12/201830/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
239EUCTR2018-002001-65-GB
(EUCTR)
13/12/201801/10/2018A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s DiseaseA Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
University of BirminghamNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
36Phase 1United Kingdom
240EUCTR2018-002629-51-ES
(EUCTR)
12/12/201816/11/2018A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200Phase 3France;United States;Spain;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2017-004997-32-ES
(EUCTR)
10/12/201817/09/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Roche Farma, S.A por delegación de Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
242NCT03759288
(ClinicalTrials.gov)
December 7, 201820/11/2018An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's Disease;IBDDrug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira®;Drug: PlaceboAllerganNULLRecruiting16 Years80 YearsAll1140Phase 2;Phase 3United States;Canada;Puerto Rico
243NCT03574948
(ClinicalTrials.gov)
December 6, 201822/6/20185-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue ScoresMulticentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue ScoresCrohn Disease;Ulcerative Colitis;Fatigue;RemissionDrug: 5-HTP;Drug: Placebo oral capsuleUniversity Hospital, GhentNULLRecruiting18 Years60 YearsAll180Phase 2Belgium
244EUCTR2018-001272-37-DE
(EUCTR)
04/12/201826/07/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
245EUCTR2017-004294-14-DK
(EUCTR)
30/11/201827/08/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLNot Recruiting Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2017-004295-55-DK
(EUCTR)
30/11/201827/08/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLNot Recruiting Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
247EUCTR2018-001272-37-GR
(EUCTR)
28/11/201809/11/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma US, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany;Serbia
248EUCTR2017-003090-34-BE
(EUCTR)
28/11/201812/10/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
SCS Boehringer Ingelheim Comm.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
249EUCTR2017-001976-48-ES
(EUCTR)
23/11/201817/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
250NCT03635112
(ClinicalTrials.gov)
November 19, 201831/7/2018Efficacy and Safety of TD-1473 in Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: TD-1473Theravance BiopharmaNULLRecruiting18 YearsN/AAll160Phase 2United States;Australia;Austria;Bulgaria;Croatia;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2018-001272-37-GB
(EUCTR)
15/11/201803/10/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - DIONE - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
252NCT03623932
(ClinicalTrials.gov)
November 13, 20184/7/2018Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn DiseaseContribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn DiseaseCrohn DiseaseDrug: immunosuppressor/TNFalpha;Behavioral: HypnosisUniversity Hospital, GrenobleNULLRecruiting18 Years65 YearsAll40N/AFrance
253EUCTR2017-000575-88-DE
(EUCTR)
13/11/201828/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan;Lithuania;Austria;Russian Federation;Israel;United States;Serbia
254EUCTR2017-000617-23-DE
(EUCTR)
13/11/201828/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan
255EUCTR2018-001272-37-ES
(EUCTR)
11/11/201809/08/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2017-004293-33-SI
(EUCTR)
06/11/201812/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
257EUCTR2017-004294-14-SI
(EUCTR)
06/11/201813/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
258EUCTR2017-004295-55-SI
(EUCTR)
06/11/201813/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
259EUCTR2015-003759-23-NO
(EUCTR)
02/11/201807/12/2020A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand
260EUCTR2018-001382-17-GB
(EUCTR)
30/10/201824/06/2019An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial - STATIC Inactive Crohn’s Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]INN or Proposed INN: MESALAZINEAlimentiv IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1580Phase 4Canada;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2017-004294-14-PT
(EUCTR)
29/10/201816/07/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
485Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
262EUCTR2017-005151-83-DE
(EUCTR)
26/10/201809/07/2018Treatment of Crohn's disease with Ustekinumab in clinical practiceINDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUS Crohn's disease
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: STELARA
Product Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA
Product Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Charité Universitätsmedizin BerlinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Germany
263EUCTR2017-004209-41-BE
(EUCTR)
25/10/201821/08/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
264NCT03723447
(ClinicalTrials.gov)
October 23, 201826/10/2018Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE TrialPain, Postoperative;Crohn Disease;Inflammatory Bowel Diseases;Colorectal Cancer;Gastrointestinal Cancer;Gastrointestinal Disease;Digestive System Disease;Pain;Pain, Neuropathic;Intestinal DiseaseDrug: Liposomal bupivacaine;Drug: Bupivacaine/epinephrine/dexamethasoneCedars-Sinai Medical CenterNULLActive, not recruiting18 Years90 YearsAll100Phase 4United States
265EUCTR2017-004293-33-NL
(EUCTR)
22/10/201812/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266EUCTR2017-004294-14-NL
(EUCTR)
22/10/201812/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
267EUCTR2017-004295-55-NL
(EUCTR)
22/10/201812/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
268EUCTR2017-004209-41-DE
(EUCTR)
16/10/201821/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
269EUCTR2018-001272-37-HU
(EUCTR)
16/10/201816/08/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
270EUCTR2017-004293-33-FI
(EUCTR)
10/10/201830/07/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2017-004294-14-FI
(EUCTR)
10/10/201830/07/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
272EUCTR2017-004295-55-FI
(EUCTR)
10/10/201831/07/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
273EUCTR2018-001272-37-BG
(EUCTR)
09/10/201831/08/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
274EUCTR2017-000617-23-PT
(EUCTR)
08/10/201801/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
983Phase 3Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
275EUCTR2017-000576-29-BE
(EUCTR)
08/10/201802/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2017-000617-23-BE
(EUCTR)
08/10/201802/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
277EUCTR2017-003359-43-DE
(EUCTR)
04/10/201819/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Turkey;Austria;Hungary;Czech Republic;Canada;Belgium;United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Poland;Croatia;Georgia;Germany
278EUCTR2017-000617-23-EE
(EUCTR)
03/10/201811/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
983Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
279EUCTR2017-000574-11-EE
(EUCTR)
03/10/201811/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2453Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
280EUCTR2017-004209-41-NL
(EUCTR)
01/10/201827/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2017-004209-41-BG
(EUCTR)
26/09/201819/07/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one year Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Serbia;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
282NCT03606499
(ClinicalTrials.gov)
September 26, 201820/7/2018Real-world Effectiveness of Ustekinumab in Participants Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-mediated Inflammatory DiseasesEffectiveness of Ustekinumab in Patients Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-Mediated Inflammatory Diseases in a Real-world SettingCrohn DiseaseDrug: UstekinumabJanssen Cilag S.A.S.NULLRecruiting18 YearsN/AAll125France
283EUCTR2017-003359-43-AT
(EUCTR)
24/09/201820/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
255Phase 2Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
284EUCTR2017-004295-55-DE
(EUCTR)
21/09/201821/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
285EUCTR2017-004294-14-BE
(EUCTR)
20/09/201828/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286JPRN-JapicCTI-183950
20/9/201807/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease Crohn's DiseaseIntervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion.
Control intervention name : Ustekinumab
INN of the control intervention : Ustekinumab
Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion.
Janssen Pharmaceutical K.K.NULLrecruiting18BOTH2000Phase 2;Phase 3Japan, North America
287EUCTR2017-000617-23-NL
(EUCTR)
17/09/201817/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
983Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
288EUCTR2017-000575-88-NL
(EUCTR)
17/09/201819/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1032Phase 3Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
289EUCTR2017-000617-23-BG
(EUCTR)
14/09/201810/07/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
290EUCTR2017-000576-29-BG
(EUCTR)
14/09/201824/07/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2017-001226-18-BE
(EUCTR)
13/09/201802/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
292EUCTR2017-001225-41-BE
(EUCTR)
13/09/201819/12/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
293EUCTR2017-001240-35-BE
(EUCTR)
13/09/201802/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
294EUCTR2017-001976-48-HU
(EUCTR)
13/09/201805/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Portugal;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Romania;Australia;Denmark;Germany;Korea, Republic of
295EUCTR2017-001225-41-CZ
(EUCTR)
12/09/201820/04/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2017-001226-18-CZ
(EUCTR)
12/09/201819/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
297EUCTR2017-002195-13-NL
(EUCTR)
10/09/201830/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Latvia;Tunisia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
298EUCTR2017-004292-31-BE
(EUCTR)
10/09/201823/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
299EUCTR2017-002195-13-HR
(EUCTR)
07/09/201816/05/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
300EUCTR2017-004292-31-DE
(EUCTR)
06/09/201806/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT03615378
(ClinicalTrials.gov)
August 30, 201816/7/2018Maintenance Dosing of Vitamin D in Crohn's DiseaseA Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in RemissionCrohns Disease;Vitamin D DeficiencyDietary Supplement: 5000 IU D3;Dietary Supplement: 1000 IU D3;Dietary Supplement: PlaceboCedars-Sinai Medical CenterNULLTerminated18 YearsN/AAll10Early Phase 1United States
302EUCTR2017-000576-29-PT
(EUCTR)
27/08/201801/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1032Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
303EUCTR2017-004209-41-CZ
(EUCTR)
27/08/201813/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
304NCT03452501
(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 LLCNULLActive, not recruiting18 YearsN/AAll150Saudi Arabia
305EUCTR2017-004209-41-GB
(EUCTR)
24/08/201822/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2017-004294-14-DE
(EUCTR)
23/08/201820/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
307EUCTR2017-001976-48-PL
(EUCTR)
23/08/201817/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
308EUCTR2017-001976-48-GB
(EUCTR)
23/08/201826/06/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
309EUCTR2017-001226-18-BG
(EUCTR)
22/08/201805/06/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
310NCT03467958
(ClinicalTrials.gov)
August 22, 201812/3/2018An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: OzanimodCelgeneNULLRecruiting12 Years75 YearsAll1200Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311EUCTR2017-001225-41-BG
(EUCTR)
22/08/201805/06/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
312EUCTR2017-001240-35-BG
(EUCTR)
22/08/201805/06/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
313NCT03546868
(ClinicalTrials.gov)
August 14, 201810/5/2018Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel DiseasePhase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease.Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDrug: [18F]FSPGAsan FoundationNULLCompleted19 Years79 YearsAll20Phase 2Korea, Republic of
314EUCTR2017-002195-13-PL
(EUCTR)
13/08/201825/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Georgia;Germany;New Zealand;Japan
315EUCTR2017-002195-13-LV
(EUCTR)
10/08/201821/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Tunisia;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2017-004295-55-SE
(EUCTR)
08/08/201808/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
317EUCTR2017-004294-14-SE
(EUCTR)
08/08/201808/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
318EUCTR2017-004293-33-PT
(EUCTR)
06/08/201827/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn¿s Disease Moderately to Severely Active Crohn¿s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
319EUCTR2017-004209-41-PL
(EUCTR)
03/08/201820/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
320EUCTR2017-002195-13-ES
(EUCTR)
30/07/201821/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2017-004209-41-FR
(EUCTR)
30/07/201814/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Russian Federation;United Kingdom;Italy;Serbia;United States;Spain;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
322EUCTR2017-002195-13-GR
(EUCTR)
27/07/201817/07/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
323EUCTR2017-000576-29-EE
(EUCTR)
25/07/201811/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
324EUCTR2017-000576-29-HU
(EUCTR)
24/07/201815/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
325EUCTR2017-000617-23-HU
(EUCTR)
24/07/201815/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
983Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326NCT03449069
(ClinicalTrials.gov)
July 23, 201822/2/2018Pediatric MSC-AFP Sub-study for Crohn's FistulaA Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-studyFistula in Ano;Crohn DiseaseDrug: MSC-AFPMayo ClinicNULLRecruiting12 Years17 YearsAll5Phase 1United States
327EUCTR2016-003191-50-SE
(EUCTR)
22/07/201814/09/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
328EUCTR2017-003359-43-HR
(EUCTR)
19/07/201816/05/2019A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease Moderate To Severe Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
255Phase 2Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
329EUCTR2017-001737-85-NL
(EUCTR)
17/07/201803/04/2018Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapyEfficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy - ADD UP Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: albendazole (Eskazole)
Product Name: albendazole
academic medical centreNULLNot RecruitingFemale: yes
Male: yes
110Phase 4Netherlands
330EUCTR2017-000617-23-ES
(EUCTR)
16/07/201814/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
983Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331EUCTR2017-004294-14-GB
(EUCTR)
13/07/201826/06/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
332EUCTR2017-004292-31-GB
(EUCTR)
13/07/201826/06/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand
333EUCTR2017-000576-29-ES
(EUCTR)
11/07/201821/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
334EUCTR2018-001546-33-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
335EUCTR2017-000576-29-SK
(EUCTR)
10/07/201817/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2017-000617-23-SK
(EUCTR)
10/07/201817/05/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan
337EUCTR2017-004292-31-DK
(EUCTR)
09/07/201809/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLNot Recruiting Female: yes
Male: yes
675Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
338EUCTR2016-003123-32-SE
(EUCTR)
09/07/201808/09/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
339EUCTR2017-000617-23-AT
(EUCTR)
06/07/201819/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
340EUCTR2017-000575-88-AT
(EUCTR)
06/07/201819/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341NCT03860571
(ClinicalTrials.gov)
July 6, 20183/2/2019Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersA Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female VolunteersUlcerative Colitis;Crohn DiseaseDrug: BT-11 Placebo;Drug: BT-11 ActiveLandos Biopharma Inc.NULLCompleted18 Years65 YearsAll70Phase 1United States
342EUCTR2017-001240-35-LT
(EUCTR)
05/07/201823/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
343EUCTR2017-002195-13-DE
(EUCTR)
03/07/201801/03/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;North Macedonia;Colombia;Italy;France;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan;Taiwan;Saudi Arabia;Slovakia
344NCT03662919
(ClinicalTrials.gov)
July 2, 20186/9/2018One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort StudyPERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort StudyArthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, UlcerativeDrug: Infliximab;Drug: AdalimumabBiogenNULLRecruiting6 YearsN/AAll3000France
345NCT03467620
(ClinicalTrials.gov)
July 20185/3/2018Cannabidiol Usage as an Adjunct Therapy for Crohn's DiseaseOral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled StudyCrohn Disease;Inflammatory Bowel Diseases;CannabisDrug: Cannabidiol;Drug: Placebo oral capsuleUniversity of Illinois at ChicagoNULLWithdrawn18 YearsN/AAll0Phase 2;Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT03599622
(ClinicalTrials.gov)
June 29, 201811/7/2018An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's DiseaseGranulomatous Colitis;Crohn's Disease;Crohn's Enteritis;Granulomatous EnteritisDrug: BMS-986165;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years75 YearsAll240Phase 2United States;Australia;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom
347EUCTR2017-002195-13-LT
(EUCTR)
28/06/201820/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
348EUCTR2017-000574-11-BE
(EUCTR)
27/06/201814/12/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
349NCT03464097
(ClinicalTrials.gov)
June 27, 201826/2/2018A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ozanimod;Other: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll485Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
350EUCTR2017-001225-41-DK
(EUCTR)
27/06/201807/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351EUCTR2017-001226-18-DE
(EUCTR)
26/06/201809/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
352EUCTR2017-003359-43-SK
(EUCTR)
26/06/201819/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Georgia;Germany
353EUCTR2017-001225-41-DE
(EUCTR)
26/06/201808/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
354EUCTR2017-001240-35-DE
(EUCTR)
26/06/201828/02/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
355NCT03472690
(ClinicalTrials.gov)
June 25, 20188/3/2018QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's DiseaseA Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's DiseaseCrohn DiseaseBiological: QBECO-SSI;Other: PlaceboQu Biologics Inc.NULLActive, not recruiting18 YearsN/AAll20Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT03559517
(ClinicalTrials.gov)
June 25, 20189/5/2018Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)Crohn's DiseaseBiological: Ontamalimab;Other: PlaceboShireNULLTerminated16 Years80 YearsAll30Phase 3United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom
357EUCTR2017-001240-35-DK
(EUCTR)
25/06/201810/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
358EUCTR2017-003359-43-HU
(EUCTR)
21/06/201825/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand
359EUCTR2017-004209-41-ES
(EUCTR)
21/06/201821/05/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
360EUCTR2017-004295-55-HR
(EUCTR)
19/06/201807/12/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2017-002195-13-CZ
(EUCTR)
19/06/201820/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
362EUCTR2017-004292-31-HR
(EUCTR)
18/06/201807/12/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
363EUCTR2017-002195-13-SK
(EUCTR)
18/06/201826/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
364EUCTR2017-004294-14-HR
(EUCTR)
18/06/201807/12/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
365EUCTR2017-000617-23-LT
(EUCTR)
15/06/201820/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366EUCTR2017-000575-88-LT
(EUCTR)
15/06/201820/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1032Phase 3United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan
367EUCTR2017-002195-13-BE
(EUCTR)
15/06/201830/03/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
368EUCTR2017-001240-35-EE
(EUCTR)
14/06/201807/05/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
369EUCTR2017-001226-18-EE
(EUCTR)
14/06/201807/05/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
370NCT04329481
(ClinicalTrials.gov)
June 12, 201829/3/2020The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD PatientsThe Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD PatientsUlcerative Colitis;Crohn Disease;Inflammatory Bowel DiseasesDietary Supplement: Mycodigest supplementTel-Aviv Sourasky Medical CenterNULLRecruiting18 Years70 YearsAll100N/AIsrael
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT03566823
(ClinicalTrials.gov)
June 11, 20189/5/2018Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)Crohn's DiseaseBiological: Ontamalimab;Other: PlaceboShireNULLTerminated16 Years80 YearsAll34Phase 3United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Turkey;Ukraine
372NCT03142321
(ClinicalTrials.gov)
June 8, 20183/5/2017Defining Predictors of RT Response to Vedolizumab in IBDDefining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic BiomarkersCrohn Disease of Small IntestineDrug: Vedolizumab 300 MG Injection [Entyvio]Washington University School of MedicineNULLRecruiting18 YearsN/AAll80Phase 4United States
373EUCTR2017-004295-55-BG
(EUCTR)
06/06/201820/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
374EUCTR2017-004294-14-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
375EUCTR2017-004292-31-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376EUCTR2017-004293-33-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
377EUCTR2017-001225-41-LT
(EUCTR)
06/06/201823/03/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
378EUCTR2017-001226-18-LT
(EUCTR)
06/06/201823/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
379NCT03477032
(ClinicalTrials.gov)
June 1, 201819/3/2018FMT in Inflammatory Bowel DiseaseFaecal Transplantation in Inflammatory Bowel DiseaseFaecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic ColitisBiological: Faecal Microbiota TransplantationSt Vincent's Hospital MelbourneNULLRecruiting18 Years65 YearsAll50Australia
380NCT03559660
(ClinicalTrials.gov)
May 30, 20185/6/2018CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)Crohn's DiseaseDrug: Certolizumab PegolUCB Biopharma S.P.R.L.NULLAvailable18 YearsN/AAllNULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381EUCTR2017-001226-18-DK
(EUCTR)
28/05/201816/02/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
382EUCTR2017-002195-13-AT
(EUCTR)
28/05/201818/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
383EUCTR2017-003359-43-BE
(EUCTR)
28/05/201806/03/2019A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
255Phase 2Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
384EUCTR2017-002258-36-NL
(EUCTR)
25/05/201817/10/2017Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA
ALFASIGMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2Spain;Belgium;Germany;Netherlands;Italy
385EUCTR2014-002311-41-NL
(EUCTR)
25/05/201818/12/2017A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPAREA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4France;Belgium;Germany;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386EUCTR2017-003359-43-LT
(EUCTR)
24/05/201817/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
255Phase 2Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
387EUCTR2016-003153-15-BE
(EUCTR)
24/05/201807/02/2018This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Czechia;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
388EUCTR2017-004293-33-SE
(EUCTR)
23/05/201808/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLNot Recruiting Female: yes
Male: yes
675Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
389EUCTR2017-003359-43-PL
(EUCTR)
23/05/201824/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
390EUCTR2017-004295-55-ES
(EUCTR)
23/05/201801/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand;Mexico;Canada;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391EUCTR2017-004294-14-LV
(EUCTR)
21/05/201831/01/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
485Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
392EUCTR2017-004295-55-LV
(EUCTR)
21/05/201831/01/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
393EUCTR2017-001226-18-LV
(EUCTR)
21/05/201807/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Ukraine;Chile;Israel;Russian Federation;Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Colombia;Switzerland;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
394EUCTR2017-004292-31-LV
(EUCTR)
21/05/201831/01/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
395EUCTR2017-004295-55-GB
(EUCTR)
18/05/201827/06/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396EUCTR2017-001240-35-NL
(EUCTR)
18/05/201808/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
397EUCTR2017-001240-35-HU
(EUCTR)
18/05/201807/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
398EUCTR2017-001225-41-NL
(EUCTR)
18/05/201808/03/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
399EUCTR2017-001226-18-HU
(EUCTR)
18/05/201807/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
400EUCTR2017-001225-41-HU
(EUCTR)
18/05/201807/03/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401EUCTR2017-003649-10-GB
(EUCTR)
15/05/201811/12/2017A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1Spain;Poland;Belgium;Germany;United Kingdom
402EUCTR2016-003191-50-HR
(EUCTR)
14/05/201829/05/2018A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan
403EUCTR2017-001240-35-PT
(EUCTR)
14/05/201801/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3United States;Portugal;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
404EUCTR2017-001226-18-PT
(EUCTR)
14/05/201801/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3United States;Portugal;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
405EUCTR2016-003123-32-HR
(EUCTR)
14/05/201829/05/2018A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406EUCTR2017-001225-41-PT
(EUCTR)
14/05/201819/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Canada;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Brazil;United Kingdom;Egypt
407EUCTR2017-002231-41-NL
(EUCTR)
14/05/201826/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary
408EUCTR2017-004292-31-ES
(EUCTR)
10/05/201823/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
409EUCTR2017-001226-18-PL
(EUCTR)
10/05/201812/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
410EUCTR2017-001240-35-ES
(EUCTR)
10/05/201810/05/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411EUCTR2017-001240-35-PL
(EUCTR)
10/05/201809/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
412EUCTR2017-001225-41-ES
(EUCTR)
10/05/201810/05/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
413EUCTR2017-001226-18-ES
(EUCTR)
09/05/201810/05/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
414EUCTR2016-003191-50-LT
(EUCTR)
07/05/201801/02/2018A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
415EUCTR2016-003179-23-BE
(EUCTR)
07/05/201816/02/2018This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416EUCTR2016-003123-32-LT
(EUCTR)
07/05/201823/01/2018A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
417EUCTR2016-003190-17-HR
(EUCTR)
04/05/201816/05/2019A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
418EUCTR2017-004294-14-CZ
(EUCTR)
03/05/201801/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
419EUCTR2016-002918-43-DK
(EUCTR)
03/05/201815/02/2018Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;France;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
420EUCTR2017-004292-31-CZ
(EUCTR)
03/05/201831/01/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421EUCTR2017-003649-10-BE
(EUCTR)
02/05/201827/02/2018A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 1United States;Poland;Spain;Belgium;Germany;United Kingdom
422EUCTR2016-000522-18-BE
(EUCTR)
02/05/201808/01/2018Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]PIBDNetNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
423ChiCTR1800015174
2018-05-012018-03-12Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's diseaseEffects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease Crohn's diseasecontrol group:placebo;Vitamin D:800IU Vitamin D;Gudangdong General Hospital, Guangdong Academy of Medical SciencesNULLPending1875Bothcontrol group:32;Vitamin D:32;China
424EUCTR2017-003649-10-DE
(EUCTR)
30/04/201807/02/2018A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 1United States;Poland;Belgium;Spain;Germany;United Kingdom
425EUCTR2017-004295-55-GR
(EUCTR)
27/04/201801/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426EUCTR2017-004294-14-GR
(EUCTR)
27/04/201828/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Russian Federation;Switzerland;Australia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
427EUCTR2017-000574-11-HR
(EUCTR)
27/04/201827/08/2018Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
428EUCTR2017-004293-33-GR
(EUCTR)
27/04/201828/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
429EUCTR2017-004295-55-PL
(EUCTR)
26/04/201820/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
430EUCTR2017-004294-14-PL
(EUCTR)
26/04/201820/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
535Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431EUCTR2017-004292-31-PL
(EUCTR)
26/04/201820/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
432EUCTR2017-004293-33-PL
(EUCTR)
26/04/201819/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
433EUCTR2017-004293-33-ES
(EUCTR)
25/04/201802/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
434EUCTR2017-003359-43-ES
(EUCTR)
25/04/201827/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand
435EUCTR2017-004294-14-ES
(EUCTR)
25/04/201802/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436EUCTR2016-000522-18-CZ
(EUCTR)
24/04/201825/04/2018Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Azathioprin
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBDNetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
437EUCTR2017-000574-11-PT
(EUCTR)
23/04/201822/12/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
438EUCTR2017-001240-35-SK
(EUCTR)
17/04/201815/11/2017A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
439EUCTR2017-001225-41-SK
(EUCTR)
17/04/201815/11/2017A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
440EUCTR2017-001226-18-SK
(EUCTR)
17/04/201815/11/2017A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT03466411
(ClinicalTrials.gov)
April 13, 20188/3/2018A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Guselkumab Dose 4;Drug: Guselkumab Dose 5;Drug: Guselkumab;Drug: Ustekinumab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll2000Phase 2;Phase 3United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Netherlands;New Zealand;North Macedonia;Poland;Portugal;Puerto Rico;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;India;Ireland;Macedonia, The Former Yugoslav Republic of;Slovenia;South Africa
442EUCTR2017-000574-11-DE
(EUCTR)
10/04/201825/10/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
443NCT03105102
(ClinicalTrials.gov)
April 9, 20184/4/2017A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: Placebo for Risankizumab SC;Drug: Risankizumab IV;Drug: Placebo for Risankizumab IV;Drug: Risankizumab SCAbbVieNULLEnrolling by invitation18 Years80 YearsAll1250Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey
444EUCTR2016-004112-35-SE
(EUCTR)
04/04/201821/06/2017A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel diseaseLow-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Sweden
445NCT03464136
(ClinicalTrials.gov)
March 29, 20187/3/2018Safety and Efficacy of Adalimumab Versus Ustekinumab for One YearA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn DiseaseBiological: Placebo for Ustekinumab;Biological: Placebo for Adalimumab;Biological: Ustekinumab (6 mg/kg);Biological: Ustekinumab (90 mg);Biological: Adalimumab (40 mg)Janssen Scientific Affairs, LLCNULLActive, not recruiting18 YearsN/AAll386Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446EUCTR2016-000522-18-GB
(EUCTR)
28/03/201805/12/2017Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL Paediatric Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
PIBD netNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312Phase 4France;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom
447EUCTR2017-001240-35-LV
(EUCTR)
28/03/201807/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
448NCT03478956
(ClinicalTrials.gov)
March 27, 201826/3/2018A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's DiseaseA Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: EtrolizumabHoffmann-La RocheNULLActive, not recruiting4 Years17 YearsAll24Phase 1Belgium;Poland;Spain;United Kingdom;Germany;United States
449EUCTR2017-001225-41-GB
(EUCTR)
27/03/201815/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
450EUCTR2017-001226-18-GB
(EUCTR)
26/03/201806/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451EUCTR2017-001240-35-GB
(EUCTR)
26/03/201806/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
452EUCTR2017-003017-25-PL
(EUCTR)
23/03/201819/12/2017Clinical Study to Evaluate the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-40346527-AAC
Product Code: PRV-6527 (JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Provention Bio, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Spain;Poland;Ukraine;Austria;Russian Federation;Germany
453EUCTR2017-004293-33-AT
(EUCTR)
23/03/201814/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
454EUCTR2017-004294-14-AT
(EUCTR)
23/03/201814/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
455EUCTR2017-004295-55-AT
(EUCTR)
23/03/201814/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT03345823
(ClinicalTrials.gov)
March 21, 201815/11/2017A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433Crohn's DiseaseDrug: Upadacitinib;Drug: Placebo for UpadacitinibAbbVieNULLEnrolling by invitation18 Years75 YearsAll747Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus
457NCT03854305
(ClinicalTrials.gov)
March 20, 201823/2/2019Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's DiseasePhase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn'sCrohn's DiseaseDrug: PRV-6527;Drug: PlaceboProvention Bio, Inc.NULLActive, not recruiting18 Years75 YearsAll93Phase 2Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
458EUCTR2017-003017-25-DE
(EUCTR)
20/03/201822/02/2018Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90Phase 2Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
459EUCTR2017-002182-21-NL
(EUCTR)
20/03/201828/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom
460EUCTR2016-002918-43-SK
(EUCTR)
16/03/201815/02/2018Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461EUCTR2017-004293-33-SK
(EUCTR)
16/03/201830/01/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
462EUCTR2017-004294-14-SK
(EUCTR)
16/03/201830/01/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
463EUCTR2017-004295-55-SK
(EUCTR)
16/03/201830/01/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
464EUCTR2017-001240-35-SE
(EUCTR)
15/03/201815/02/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
465EUCTR2017-001225-41-SE
(EUCTR)
15/03/201812/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466EUCTR2017-000574-11-NL
(EUCTR)
15/03/201802/11/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
467EUCTR2017-003017-25-ES
(EUCTR)
14/03/201815/12/2017Clinical Study to Evaluate the Efficacy and Safety of PRV-6527, an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90Phase 2Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
468EUCTR2017-000574-11-IE
(EUCTR)
13/03/201804/09/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
469EUCTR2017-001240-35-AT
(EUCTR)
12/03/201828/02/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
470EUCTR2017-004293-33-LT
(EUCTR)
12/03/201801/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471EUCTR2017-001226-18-AT
(EUCTR)
12/03/201828/02/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
472EUCTR2017-001226-18-SE
(EUCTR)
12/03/201816/02/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
473EUCTR2017-004295-55-LT
(EUCTR)
12/03/201801/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
474EUCTR2017-004294-14-LT
(EUCTR)
12/03/201801/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
475EUCTR2017-001225-41-LV
(EUCTR)
09/03/201814/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476EUCTR2017-004295-55-HU
(EUCTR)
08/03/201830/01/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
477NCT03440385
(ClinicalTrials.gov)
March 7, 201814/2/2018Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ozanimod;Other: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll600Phase 3United States;Australia;Austria;Bulgaria;Canada;China;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;Brazil
478NCT03709628
(ClinicalTrials.gov)
March 7, 201811/4/2018A Study of a FimH Blocker, EB8018, in Crohn's Disease PatientsAn Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease PatientsCrohn DiseaseDrug: EB8018 (First-in-class FimH blocker)EnteromeNULLActive, not recruiting18 YearsN/AAll8Phase 1Austria;France;Germany;Italy
479EUCTR2017-000574-11-GB
(EUCTR)
06/03/201821/09/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
480EUCTR2017-004293-33-HU
(EUCTR)
06/03/201829/01/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481EUCTR2017-004294-14-HU
(EUCTR)
06/03/201830/01/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
485Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
482NCT03329209
(ClinicalTrials.gov)
March 5, 201830/10/2017A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese ParticipantsAn Open-Label, Single-Center, Phase 1 Study to Determine the Pharmacokinetics of Single Intravenous Dose of Vedolizumab 300 mg in Healthy Adult Chinese SubjectsColitis, Ulcerative;Crohn DiseaseDrug: VedolizumabTakedaNULLCompleted18 Years45 YearsAll16Phase 1China
483JPRN-jRCTs021200013
28/02/201831/07/2020A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST Crohn's disease
Crohn's disease;D003424
Ustekinumab monotherapy for 32 weeks.Moroi RintaoNULLRecruiting>= 18age old<= 75age oldBoth80Phase 3Japan
484NCT03283085
(ClinicalTrials.gov)
February 27, 201812/9/2017A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)Crohn's Disease;Ulcerative ColitisDrug: 25 mg Ontamalimab;Drug: 75 mg OntamalimabShireNULLRecruiting16 Years80 YearsAll451Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom
485JPRN-UMIN000030884
2018/02/2720/02/2018A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. Crohn's diseaseUstekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.
Tohoku University Hospital, Division of GastroenterologyNULLRecruiting18years-old75years-oldMale and Female80Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486NCT03440372
(ClinicalTrials.gov)
February 27, 201814/2/2018Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ozanimod;Other: PlaceboCelgeneNULLRecruiting12 Years75 YearsAll600Phase 3United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Moldova, Republic of;Norway;Poland;Romania;Russian Federation;Saudi Arabia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
487NCT03801928
(ClinicalTrials.gov)
February 23, 201811/12/2018Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel DiseaseOBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADAInflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC)Drug: InflectraPfizerNULLCompleted18 YearsN/AAll118United States;Canada
488EUCTR2016-003153-15-AT
(EUCTR)
19/02/201806/02/2018This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
489EUCTR2017-001225-41-AT
(EUCTR)
19/02/201807/02/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
747Phase 3Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
490EUCTR2016-003179-23-AT
(EUCTR)
19/02/201816/02/2018This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491NCT03351647
(ClinicalTrials.gov)
February 14, 201830/10/2017Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's DiseaseIdentification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and AntibodiesCrohn DiseaseBiological: Evaluation of biological predictive factors of clinical response to ustekinumabHospices Civils de LyonNULLUnknown status18 Years18 YearsAll50France
492EUCTR2016-003190-17-IE
(EUCTR)
06/02/201825/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
493EUCTR2016-003123-32-IE
(EUCTR)
06/02/201825/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
494EUCTR2017-003017-25-AT
(EUCTR)
06/02/201811/12/2017Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90Phase 2Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
495EUCTR2016-003191-50-IE
(EUCTR)
06/02/201825/07/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496EUCTR2017-002258-36-BE
(EUCTR)
05/02/201802/10/2017Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
ALFASIGMA S.P.A.NULLNot Recruiting Female: yes
Male: yes
180Phase 2Spain;Belgium;Netherlands;Germany
497NCT03395184
(ClinicalTrials.gov)
February 2, 20185/12/2017Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's DiseaseA PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASECrohn's DiseaseDrug: Placebo PF-06651600;Drug: Placebo PF-06700841;Drug: PF-06651600;Drug: PF-06700841PfizerNULLRecruiting18 Years75 YearsAll250Phase 2United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Georgia;Germany;Hungary;Italy;Korea, Republic of;Lebanon;Poland;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Turkey;Ukraine;United Arab Emirates
498NCT03358706
(ClinicalTrials.gov)
February 2, 201827/11/2017A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative ColitisA Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.Crohn Disease;Ulcerative ColitisDrug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mgJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll57Phase 1United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark
499EUCTR2016-003190-17-BE
(EUCTR)
01/02/201814/02/2018A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
579Phase 3Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
500NCT03059849
(ClinicalTrials.gov)
February 1, 201813/2/2017Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBDBrief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBDCrohn Disease;Ulcerative ColitisDrug: AdalimumabMcMaster UniversityNULLWithdrawn18 Years80 YearsAll0Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501EUCTR2016-003123-32-BE
(EUCTR)
01/02/201808/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
855Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
502EUCTR2016-003191-50-BE
(EUCTR)
01/02/201814/02/2018A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
503NCT03185000
(ClinicalTrials.gov)
February 201813/4/2017Treg Immunotherapy in Crohn's DiseaseA Double-blind, Placebo Controlled, First Into Human Clinical Trial of T Regulatory Cells (TR004) for Inflammatory Bowel Disease Using (ex Vivo) Treg ExpansionCrohn DiseaseDrug: TR004 (Treg immunotherapy);Other: PlaceboKing's College LondonGuy's and St Thomas' NHS Foundation Trust;Medical Research Council;Imperial College London;St. George's Hospital, London;Miltenyi biotechNot yet recruiting18 Years80 YearsAll24Phase 1;Phase 2NULL
504EUCTR2017-000574-11-LT
(EUCTR)
30/01/201831/10/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
505EUCTR2017-000574-11-HU
(EUCTR)
23/01/201827/10/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2453Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
506EUCTR2017-002182-21-PL
(EUCTR)
17/01/201813/10/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
507EUCTR2017-002231-41-PL
(EUCTR)
17/01/201813/10/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
508EUCTR2016-003123-32-GR
(EUCTR)
16/01/201808/11/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
509EUCTR2016-003190-17-GR
(EUCTR)
16/01/201815/11/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
510EUCTR2016-003191-50-GR
(EUCTR)
16/01/201816/11/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511EUCTR2016-003191-50-NL
(EUCTR)
15/01/201808/08/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan
512EUCTR2017-002231-41-BE
(EUCTR)
10/01/201814/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
513EUCTR2017-002182-21-BE
(EUCTR)
10/01/201814/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
514EUCTR2016-003190-17-DE
(EUCTR)
09/01/201819/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
515EUCTR2016-003123-32-DE
(EUCTR)
09/01/201819/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516EUCTR2016-003191-50-DE
(EUCTR)
09/01/201820/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
517EUCTR2017-000725-12-IT
(EUCTR)
08/01/201809/11/2020A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. - - Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: [Cx601]
TIGENIX S.A.UNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
326Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
518EUCTR2017-003017-25-HU
(EUCTR)
08/01/201813/11/2017Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Provention Bio, Inc.NULLNot Recruiting Female: yes
Male: yes
90Phase 2Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
519EUCTR2017-000574-11-BG
(EUCTR)
04/01/201824/11/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil
520EUCTR2016-003190-17-LT
(EUCTR)
29/12/201717/10/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Serbia;Portugal;United States;Belarus;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521EUCTR2016-000522-18-NL
(EUCTR)
28/12/201703/07/2017Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. - REDUCE-RISKincd-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]PIBDNetNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom
522EUCTR2017-000574-11-AT
(EUCTR)
22/12/201730/10/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
523EUCTR2016-003179-23-DE
(EUCTR)
19/12/201714/02/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
524EUCTR2017-002231-41-DE
(EUCTR)
18/12/201714/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
525EUCTR2017-002182-21-DE
(EUCTR)
18/12/201713/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526NCT03104413
(ClinicalTrials.gov)
December 18, 20174/4/2017A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic TreatmentA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic TreatmentCrohn's DiseaseDrug: placebo for risankizumab IV;Drug: risankizumab SC;Drug: risankizumab IVAbbVieNULLActive, not recruiting16 Years80 YearsAll618Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey
527EUCTR2017-002182-21-FR
(EUCTR)
18/12/201715/12/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
528EUCTR2017-000574-11-SK
(EUCTR)
13/12/201721/11/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2453Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Germany;Netherlands
529NCT03345849
(ClinicalTrials.gov)
December 7, 201715/11/2017A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic TherapiesCrohn's DiseaseDrug: Upadacitinib;Drug: Placebo for UpadacitinibAbbVieNULLRecruiting18 Years75 YearsAll501Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus
530EUCTR2017-002258-36-ES
(EUCTR)
04/12/201703/10/2017Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA
ALFASIGMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2Spain;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531NCT02974322
(ClinicalTrials.gov)
December 1, 201723/11/2016A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's DiseaseCrohn DiseaseDrug: GED-0301;Drug: PlaceboCelgeneNULLWithdrawn12 YearsN/AAll0Phase 3United States;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic
532NCT03345836
(ClinicalTrials.gov)
November 29, 201715/11/2017A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic TherapyCrohn's DiseaseOther: Matching placebo for upadacitinib;Drug: upadacitinibAbbVieNULLRecruiting18 Years75 YearsAll645Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus
533NCT02559713
(ClinicalTrials.gov)
November 29, 201723/9/2015Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's DiseaseAn Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab TherapeuticallyColitis, Ulcerative;Crohn's DiseaseDrug: VedolizumabTakedaNULLCompleted18 YearsN/AFemale11Phase 4United States
534EUCTR2016-003190-17-GB
(EUCTR)
28/11/201720/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Belarus;Portugal;Hong Kong;Taiwan
535EUCTR2016-003123-32-GB
(EUCTR)
28/11/201720/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536EUCTR2016-003153-15-DE
(EUCTR)
28/11/201713/04/2017This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;France;Hungary;Czech Republic;Canada;Belgium;Spain;Poland;Austria;Germany;United Kingdom;Italy
537EUCTR2016-003191-50-GB
(EUCTR)
28/11/201724/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
538NCT03362736
(ClinicalTrials.gov)
November 27, 201730/11/2017An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's DiseaseAn Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: UstekinumabJanssen Research & Development, LLCNULLNo longer available18 YearsN/AAllBrazil
539EUCTR2017-002258-36-DE
(EUCTR)
21/11/201701/08/2017 Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrenceA Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
ALFASIGMA S.P.A.NULLNot Recruiting Female: yes
Male: yes
180Phase 2Spain;Belgium;Netherlands;Germany
540EUCTR2017-000725-12-FR
(EUCTR)
16/11/201725/11/2019A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
326Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
541EUCTR2017-002182-21-GB
(EUCTR)
16/11/201711/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
542EUCTR2017-002231-41-GB
(EUCTR)
15/11/201711/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
543EUCTR2016-003190-17-EE
(EUCTR)
13/11/201730/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
544EUCTR2016-003190-17-BG
(EUCTR)
08/11/201728/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
545EUCTR2016-003123-32-BG
(EUCTR)
08/11/201728/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546EUCTR2016-003191-50-BG
(EUCTR)
08/11/201727/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
547EUCTR2016-003190-17-NL
(EUCTR)
07/11/201710/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
579Phase 3Serbia;Portugal;United States;Belarus;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
548EUCTR2016-002763-34-NL
(EUCTR)
06/11/201714/08/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
549EUCTR2016-001367-36-NL
(EUCTR)
06/11/201714/08/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
550EUCTR2017-002545-30-GB
(EUCTR)
06/11/201707/06/2018Controlled trial to assess low intensity autologous stem cell transplant in refractory Crohn's DiseaseAutologous Stem cell Transplantation In refractory Crohn's disease - Low Intensity Therapy Evaluation - ASTIClite Refractory Crohn's Disease
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: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Trade Name: Filgrastim
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Fludarabine
Product Name: Fludarabine
INN or Proposed INN: Fludarabine phosphate
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Barts Health NHS TrustNULLNot RecruitingFemale: yes
Male: yes
99Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551NCT03357471
(ClinicalTrials.gov)
November 3, 201723/11/2017Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's DiseaseDrug: e-DeviceUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll70Phase 3United States
552NCT03167437
(ClinicalTrials.gov)
October 30, 201724/5/2017Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn s DiseaseAn Open-Label, Phase I/II Pilot Study to Assess the Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn s DiseaseCrohn's DiseaseDrug: VorinostatNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting18 Years65 YearsAll35Phase 1;Phase 2United States
553NCT03495973
(ClinicalTrials.gov)
October 25, 201728/3/2018Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's DiseaseProspective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)Crohn DiseaseDrug: UstekinumabJanssen-Cilag Ltd.NULLActive, not recruiting18 YearsN/AAll110Sweden
554EUCTR2016-003191-50-ES
(EUCTR)
25/10/201720/10/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
555EUCTR2016-003190-17-ES
(EUCTR)
25/10/201720/10/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556EUCTR2017-002231-41-HU
(EUCTR)
25/10/201719/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
557EUCTR2016-003123-32-ES
(EUCTR)
25/10/201720/10/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
558EUCTR2017-002182-21-HU
(EUCTR)
25/10/201712/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
559NCT03220243
(ClinicalTrials.gov)
October 19, 201714/7/2017Stem Cell Coated Fistula Plug in Patients With Crohn's RVFA Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Rectovaginal Fistulizing Crohn's DiseaseFistula Vagina;Crohn DiseaseDrug: MSC-AFPMayo ClinicNULLCompleted18 Years65 YearsFemale5Phase 1United States
560EUCTR2014-005376-29-HU
(EUCTR)
13/10/201730/08/2017An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of Crohn's disease versus subject with longer exisiting Crohn's diseaseAn open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: EntyvioAcademic Medical Center, GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 4Hungary;Belgium;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
561EUCTR2015-001924-40-HR
(EUCTR)
13/10/201702/11/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
562EUCTR2016-003191-50-EE
(EUCTR)
10/10/201710/08/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
959Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
563EUCTR2016-003123-32-EE
(EUCTR)
10/10/201728/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
564EUCTR2016-002918-43-PT
(EUCTR)
09/10/201711/08/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3France;Portugal;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
565NCT03194529
(ClinicalTrials.gov)
October 9, 201719/6/2017FMT in Pediatric Crohn's DiseaseSafety of FMT in Maintenance of Pediatric Crohn's DiseaseCrohn Disease;Pediatric Crohns DiseaseBiological: FMTChildren's Hospital Los AngelesNULLCompleted7 Years21 YearsAll9Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
566EUCTR2016-003190-17-CZ
(EUCTR)
02/10/201719/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
567NCT03279081
(ClinicalTrials.gov)
September 15, 201721/7/2017Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 WeeksCrohn's DiseaseDrug: Cx601;Other: PlaceboTigenix S.A.U.NULLRecruiting18 YearsN/AAll554Phase 3United States;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;United Kingdom
568EUCTR2016-003123-32-SK
(EUCTR)
15/09/201723/05/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
569EUCTR2016-003191-50-CZ
(EUCTR)
13/09/201721/07/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
570EUCTR2017-000725-12-BE
(EUCTR)
12/09/201701/06/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
554Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Israel;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
571EUCTR2017-000725-12-HU
(EUCTR)
07/09/201710/07/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
572EUCTR2017-000725-12-PL
(EUCTR)
03/09/201728/07/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Belgium;Poland;Israel;Germany;United Kingdom;Italy
573JPRN-JapicCTI-184152
01/9/201711/10/2018Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's diseaseInvestigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease Crohn's diseaseIntervention name : Budesonide ( Zentacort Capsules 3mg )
INN of the intervention : Budesonide
Dosage And administration of the intervention : Oral
ZERIA Pharmaceutical Co., Ltd.NULLrecruitingBOTH200NANULL
574NCT02872506
(ClinicalTrials.gov)
September 201716/8/2016Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical ResectionComparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical ResectionQuality of LifeDrug: Anti TNF;Procedure: ileocecal resectionUniversity Hospital, LilleNULLWithdrawn18 YearsN/AAll0N/ANULL
575EUCTR2016-003191-50-PT
(EUCTR)
28/08/201721/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
576EUCTR2016-003190-17-PT
(EUCTR)
28/08/201721/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
577EUCTR2016-003123-32-PT
(EUCTR)
28/08/201721/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
578EUCTR2016-003123-32-AT
(EUCTR)
25/08/201731/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Norway;Japan;New Zealand;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany
579EUCTR2016-003190-17-AT
(EUCTR)
25/08/201731/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
580EUCTR2016-003191-50-SK
(EUCTR)
23/08/201731/05/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581ChiCTR-INR-17012532
2017-08-232017-09-01The use of indocyanine green fluorescent angiography to guide the surgical treatment of Crohn's diseaseThe use of indocyanine green fluorescent angiography to guide the surgical treatment of Crohn's disease: a single-center randomized single-blind cohort study Crohn's diseaseIntervention group:Indocyanine green fluorescent angiography;control group:Physiological saline;Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting1870BothIntervention group:40;control group:40;China
582EUCTR2016-003190-17-SK
(EUCTR)
23/08/201724/05/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
583EUCTR2016-003153-15-CZ
(EUCTR)
21/08/201713/04/2017This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Austria;Germany;Italy;United Kingdom
584EUCTR2016-003191-50-LV
(EUCTR)
18/08/201725/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
959Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
585EUCTR2017-000725-12-CZ
(EUCTR)
08/08/201726/04/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586EUCTR2016-003191-50-AT
(EUCTR)
03/08/201731/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
587NCT03234907
(ClinicalTrials.gov)
August 3, 201726/7/2017Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Vedolizumab IV;Drug: PlaceboTakedaNULLCompleted18 Years80 YearsAll215Phase 3China
588NCT03162432
(ClinicalTrials.gov)
August 1, 201715/5/2017High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving RemicadeHigh Dose Interval Vitamin D Supplementation in Patients With IBD Receiving RemicadeIBD;Ulcerative Colitis;Crohn DiseaseDrug: Vitamin D3Boston Children's HospitalNULLCompleted7 Years25 YearsAll50Phase 3United States
589EUCTR2016-003153-15-GB
(EUCTR)
01/08/201710/04/2017This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Czechia;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany
590EUCTR2015-000852-12-BE
(EUCTR)
31/07/201724/03/2016Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 18.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
126Phase 4France;United States;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591EUCTR2016-003190-17-LV
(EUCTR)
31/07/201701/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
592EUCTR2016-003123-32-LV
(EUCTR)
31/07/201701/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
593EUCTR2017-000725-12-ES
(EUCTR)
26/07/201706/06/2017A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue
Product Code: Cx601
INN or Proposed INN: To be determined
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
326Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy
594EUCTR2016-003190-17-DK
(EUCTR)
25/07/201719/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
595EUCTR2016-003191-50-DK
(EUCTR)
19/07/201718/07/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596EUCTR2015-000609-38-GB
(EUCTR)
17/07/201710/05/2018A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
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]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
597NCT02330211
(ClinicalTrials.gov)
July 17, 201729/12/2014Fecal Microbiota Transplant (FMT) in Pediatric Active Crohn's ColitisA Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Crohn's ColitisInflammatory Bowel Diseases;Crohn DiseaseBiological: Fecal Microbiota Transplant;Biological: PlaceboStacy A. KahnNULLCompleted5 Years30 YearsAll4Phase 1;Phase 2United States
598EUCTR2016-003153-15-IT
(EUCTR)
17/07/201720/11/2020This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn¿s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn¿s Disease - This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as Perianal Fistulizing Crohn¿s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
GILEAD SCIENCES INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany
599NCT03169894
(ClinicalTrials.gov)
July 14, 201724/5/2017Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's DiseasePhase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFa Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFa-Resistant Crohn's Disease [TRaCk LIGHT])Crohn DiseaseDrug: MDGN-002Aevi Genomic Medicine, LLC, a Cerecor companyNULLRecruiting18 Years65 YearsAll8Phase 1United States
600NCT03219359
(ClinicalTrials.gov)
July 12, 201713/7/2017Autologous Stem Cell Transplant for Crohn's DiseaseMaintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD)Crohn DiseaseProcedure: Autologous stem cell transplant;Drug: Cyclophosphamide;Drug: Thymoglobulin;Drug: Methylprednisolone;Drug: VedolizumabIcahn School of Medicine at Mount SinaiNULLRecruiting18 YearsN/AAll50Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601EUCTR2016-001956-22-DE
(EUCTR)
04/07/201728/10/2016A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 1France;United States;Canada;Poland;Belgium;Germany
602JPRN-UMIN000028139
2017/07/0407/07/2017Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease Crohn's diseaseTreatment with UstekinumabGraduate School of Medical Sciences, Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female50Not selectedJapan
603EUCTR2016-002918-43-DE
(EUCTR)
03/07/201713/02/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
604NCT03014219
(ClinicalTrials.gov)
July 20174/1/2017Phase 1 Crohn's Pediatric Sub-study of MSC AFPA Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-studyPerianal FistulaDrug: Only 1 arm: treatment with MSC-AFPWilliam A. Faubion, M.D.NULLWithdrawn12 Years17 YearsAll0Phase 1United States
605EUCTR2016-002763-34-HR
(EUCTR)
26/06/201712/09/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606EUCTR2015-001924-40-PT
(EUCTR)
26/06/201701/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
607EUCTR2016-001367-36-HR
(EUCTR)
26/06/201712/09/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
608JPRN-jRCTs041180126
17/06/201723/03/2019CD Alfacalcidol studyThe study of effect of Alfacalcidol treatment on Crohn's disease Crohn's diseaseadministration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level.Nakamura MasanaoNULLRecruiting>= 18age oldNot applicableBoth36Phase 2Japan
609NCT03267238
(ClinicalTrials.gov)
June 16, 201724/7/2017Fecal Microbial Transplantation in Patients With Crohn's DiseaseFecal Microbial Transplantation in Patients With Crohn's DiseaseCrohn DiseaseBiological: Fecal Microbial TransplantationStony Brook UniversityNULLActive, not recruiting7 YearsN/AAll9Early Phase 1United States
610NCT03235180
(ClinicalTrials.gov)
June 16, 201727/7/2017Ultrasound Evaluation of Crohn's DiseaseUltrasound Evaluation of Crohn's DiseaseCrohn DiseaseDrug: Sulfur Hexafluoride;Device: Ultrasound Elastography;Device: Ultrasound Vascularity;Device: Magnetic Resonance Enterography (MRE)Mayo ClinicNULLEnrolling by invitation18 YearsN/AAll100Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611EUCTR2016-002918-43-NL
(EUCTR)
14/06/201702/03/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;France;Belgium;Spain;Germany;Netherlands;Italy;United Kingdom;Sweden
612EUCTR2015-001924-40-BE
(EUCTR)
14/06/201706/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Netherlands;Latvia;Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark
613NCT02764762
(ClinicalTrials.gov)
June 12, 20175/5/2016Triple Combination Therapy in High Risk Crohn's Disease (CD)An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing ComplicationsCrohn DiseaseDrug: Vedolizumab;Drug: Adalimumab;Drug: MethotrexateTakedaNULLActive, not recruiting18 Years65 YearsAll55Phase 4United States;Canada
614EUCTR2015-001924-40-IT
(EUCTR)
12/06/201723/02/2018A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Other descriptive name: GED-0301
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Other descriptive name: GED-0301
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
615EUCTR2016-003153-15-HU
(EUCTR)
08/06/201713/04/2017This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
616EUCTR2016-003153-15-PL
(EUCTR)
07/06/201719/04/2017This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy;United Kingdom
617EUCTR2015-003759-23-CZ
(EUCTR)
01/06/201730/06/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
618NCT03393247
(ClinicalTrials.gov)
June 1, 20178/7/2017The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CDThe Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort StudyCrohn DiseaseDrug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14Sixth Affiliated Hospital, Sun Yat-sen UniversityNULLUnknown status14 Years60 YearsAll160N/AChina
619EUCTR2016-001367-36-NO
(EUCTR)
31/05/201709/11/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Iceland;New Zealand;Japan;Sweden
620EUCTR2016-002763-34-SE
(EUCTR)
24/05/201727/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621EUCTR2016-001367-36-SE
(EUCTR)
24/05/201727/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
622JPRN-UMIN000025961
2017/05/2101/03/2017The study of effect of Alfacalcidol treatment on Crohn's diseaseThe study of effect of Alfacalcidol treatment on Crohn's disease - The study of effect of Alfacalcidol treatment on Crohn's disease Crohn's diseaseOral treatment of Alfacalcidol 1 microgram/day for 3 monthNagoya University HospitalNULLRecruiting18years-oldNot applicableMale and Female31Not selectedJapan
623NCT03155945
(ClinicalTrials.gov)
May 18, 201711/5/2017Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal PainA Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal PainCrohn's Disease;Abdominal PainDrug: APD371Arena PharmaceuticalsNULLCompleted18 Years80 YearsAll14Phase 2United States
624EUCTR2015-001924-40-GB
(EUCTR)
17/05/201727/01/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
625EUCTR2016-000612-14-HR
(EUCTR)
10/05/201707/06/2017BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity Moderately to severely active Crohn’s disease
MedDRA version: 20.0;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: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626NCT03105128
(ClinicalTrials.gov)
May 10, 20174/4/2017A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SCAbbVieNULLActive, not recruiting16 Years80 YearsAll931Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Finland;France;Hungary;Turkey
627EUCTR2016-002763-34-IS
(EUCTR)
09/05/201727/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
628EUCTR2016-001367-36-IS
(EUCTR)
09/05/201727/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of
629EUCTR2016-002763-34-GR
(EUCTR)
05/05/201703/01/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
630EUCTR2015-001924-40-GR
(EUCTR)
05/05/201720/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
631EUCTR2016-003153-15-ES
(EUCTR)
03/05/201704/05/2017This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease Perianal Fistulizing Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Israel;Germany;Italy;United Kingdom
632EUCTR2016-002204-84-BE
(EUCTR)
02/05/201706/02/2017A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Product Name: LY3074828
INN or Proposed INN: Not assigned
Other descriptive name: LY3074828
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Netherlands;Japan;Moldova, Republic of
633EUCTR2016-003179-23-PL
(EUCTR)
27/04/201701/03/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Germany
634EUCTR2016-002204-84-PL
(EUCTR)
27/04/201720/01/2017A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of
635EUCTR2016-003179-23-HU
(EUCTR)
26/04/201706/03/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636EUCTR2016-002204-84-NL
(EUCTR)
25/04/201708/12/2016A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of
637EUCTR2015-001924-40-NL
(EUCTR)
24/04/201708/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
638NCT02994836
(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 PrincesaNULLRecruiting18 YearsN/AAll194Phase 4Spain
639EUCTR2015-001924-40-FR
(EUCTR)
20/04/201727/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
640NCT03107793
(ClinicalTrials.gov)
April 19, 201728/3/2017Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With UstekinumabCrohn DiseaseDrug: UstekinumabJanssen-Cilag Ltd.NULLActive, not recruiting18 YearsN/AAll500Phase 3Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Portugal;Slovakia;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641EUCTR2016-002939-15-NL
(EUCTR)
18/04/201722/02/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126Phase 2United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Netherlands;Germany;Norway
642NCT03108326
(ClinicalTrials.gov)
April 15, 201730/3/2017Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s DiseaseReal World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term OutcomeCrohn DiseaseBiological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraCed Service GmbHNULLRecruiting18 Years80 YearsAll900Germany
643EUCTR2016-003179-23-GB
(EUCTR)
13/04/201709/02/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
644EUCTR2015-001924-40-DE
(EUCTR)
12/04/201706/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
645EUCTR2015-001924-40-ES
(EUCTR)
07/04/201710/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
646EUCTR2015-001924-40-HU
(EUCTR)
07/04/201709/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden
647EUCTR2015-003759-23-HU
(EUCTR)
07/04/201728/02/2017A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
648EUCTR2016-003179-23-CZ
(EUCTR)
06/04/201715/02/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
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]
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
649EUCTR2016-002939-15-DE
(EUCTR)
05/04/201702/11/2016A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
650EUCTR2016-003179-23-FR
(EUCTR)
04/04/201704/04/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2Italy;United States;Spain;Ukraine;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
651EUCTR2015-001924-40-DK
(EUCTR)
04/04/201707/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
652EUCTR2016-002918-43-BE
(EUCTR)
03/04/201702/02/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;France;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
653EUCTR2016-001367-36-BE
(EUCTR)
31/03/201708/08/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1320Phase 3Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden
654EUCTR2015-001924-40-LV
(EUCTR)
31/03/201702/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
655EUCTR2016-000612-14-GR
(EUCTR)
31/03/201702/02/2017BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. Moderately to severely active Crohn’s disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
286Phase 3United States;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
656EUCTR2016-002763-34-BE
(EUCTR)
31/03/201708/08/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
657EUCTR2016-001367-36-GR
(EUCTR)
31/03/201703/01/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
658EUCTR2015-001924-40-FI
(EUCTR)
30/03/201728/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
659EUCTR2015-001963-37-FI
(EUCTR)
30/03/201723/02/2017A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
660EUCTR2016-002939-15-HU
(EUCTR)
29/03/201706/01/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126Phase 2United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Germany;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
661NCT03090139
(ClinicalTrials.gov)
March 28, 201722/3/2017Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging MarketsIndicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE)Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel DiseasesDrug: Anti-TNF TherapyTakedaNULLCompleted18 YearsN/AAll1731Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey
662EUCTR2016-001367-36-DE
(EUCTR)
27/03/201727/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
663EUCTR2016-002763-34-DE
(EUCTR)
27/03/201727/01/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Portugal;United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Slovakia;India;Serbia;France
664EUCTR2016-001367-36-BG
(EUCTR)
23/03/201712/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
665EUCTR2016-002763-34-BG
(EUCTR)
23/03/201712/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
666EUCTR2016-002204-84-AT
(EUCTR)
22/03/201711/11/2016A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Product Name: LY3074828
INN or Proposed INN: LY3074828
Other descriptive name: LY3074828
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of
667EUCTR2015-001924-40-CZ
(EUCTR)
21/03/201701/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden
668NCT03009396
(ClinicalTrials.gov)
March 18, 201726/12/2016Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's DiseaseAn Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 StudyCrohn DiseaseDrug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimineRedHill Biopharma LimitedNULLCompleted18 Years76 YearsAll54Phase 3United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia
669EUCTR2015-001924-40-SK
(EUCTR)
16/03/201703/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden
670EUCTR2016-002918-43-SE
(EUCTR)
15/03/201719/01/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
671NCT03027193
(ClinicalTrials.gov)
March 15, 201719/1/2017A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult VolunteersA Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult VolunteersCrohn Disease;Mycobacterium Avium Subspecies ParatuberculosisBiological: ChAdOx2 HAV;Biological: MVA HAVUniversity of OxfordNULLCompleted18 Years50 YearsAll28Phase 1United Kingdom
672EUCTR2015-001179-36-BG
(EUCTR)
14/03/201717/01/2017Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 Moderately to Severely Active Crohn's Disease
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]
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
673EUCTR2016-001367-36-PT
(EUCTR)
13/03/201705/01/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Norway;United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Iceland;New Zealand;Japan;Sweden
674EUCTR2016-002763-34-PT
(EUCTR)
13/03/201705/01/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3Serbia;United States;Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
675EUCTR2016-002939-15-NO
(EUCTR)
09/03/201720/03/2019A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126Phase 2United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Norway;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
676EUCTR2016-000786-24-IT
(EUCTR)
07/03/201730/11/2016Efficacy and safety of thalidomide in pediatric patients with Crohn's diseaseThalidomide, a novel immunological treatment to modify the natural history of paediatric Crohn's disease: a new proposal from a well-established paediatric research network - Talidomide in Crohn disease in Pediatrics Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
IRCCS Burlo GarofoloNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
124Phase 3Italy
677EUCTR2016-002918-43-GB
(EUCTR)
28/02/201710/01/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;Belgium;Spain;Netherlands;Germany;United Kingdom
678JPRN-UMIN000026330
2017/02/2728/02/2017Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's diseaseEfficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients Crohn diseaseInfliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
University of ToyamaNULLComplete: follow-up continuing20years-oldNot applicableMale and Female30Not selectedJapan
679EUCTR2016-003797-40-BE
(EUCTR)
23/02/201728/10/2016A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditionsA Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334
Arena Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Germany
680EUCTR2016-003797-40-DE
(EUCTR)
21/02/201709/11/2016A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditionsA Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334
Arena Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
681EUCTR2015-001924-40-AT
(EUCTR)
21/02/201718/01/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
682EUCTR2016-003179-23-ES
(EUCTR)
21/02/201720/02/2017This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Small Bowel Crohn’s Disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Israel;Germany;Italy;United Kingdom
683EUCTR2016-002939-15-SK
(EUCTR)
16/02/201712/01/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
684EUCTR2016-002763-34-SK
(EUCTR)
16/02/201712/01/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
685EUCTR2016-001367-36-SK
(EUCTR)
16/02/201712/01/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
686EUCTR2016-001367-36-HU
(EUCTR)
08/02/201708/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
687EUCTR2016-002763-34-HU
(EUCTR)
08/02/201708/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
688EUCTR2016-002763-34-CZ
(EUCTR)
08/02/201716/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
689EUCTR2016-001367-36-CZ
(EUCTR)
08/02/201716/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
690EUCTR2016-002939-15-AT
(EUCTR)
07/02/201705/01/2017A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
VHsquared LtdNULLNot Recruiting Female: yes
Male: yes
126Phase 2United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Germany;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
691EUCTR2016-002204-84-CZ
(EUCTR)
02/02/201713/10/2016A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of
692EUCTR2016-002204-84-GB
(EUCTR)
01/02/201730/09/2016A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of
693NCT03755583
(ClinicalTrials.gov)
February 1, 201718/11/2018Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's DiseaseEffect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's DiseaseCrohn Disease;Enteral Nutrition;Gastrointestinal MicrobiomeDietary Supplement: Exclusive Enteral NutritionChildren's Hospital of Fudan UniversityNULLCompleted1 Year17 YearsAll31N/AChina
694JPRN-jRCTs031180415
01/02/201722/03/2019A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseSingle center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults).
FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
A-FMT arm : Patient undergoes FMT two days after AFM therapy.
Ishikawa DaiNULLRecruiting>= 6age oldNot applicableBoth120N/AJapan
695JPRN-UMIN000025846
2017/02/0101/02/2017A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease ulcerative colitis, Crohn's diseaseAdministration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeksJuntendo university school of medicineDepartment of gastroenterologyNULLRecruiting16years-oldNot applicableMale and Female60Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
696EUCTR2016-002763-34-AT
(EUCTR)
31/01/201715/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
697EUCTR2016-001367-36-ES
(EUCTR)
31/01/201701/02/2017A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
698EUCTR2016-001367-36-AT
(EUCTR)
31/01/201715/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
699EUCTR2016-002763-34-ES
(EUCTR)
31/01/201730/01/2017A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
700EUCTR2015-001179-36-CZ
(EUCTR)
30/01/201715/11/2016Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 Moderately to Severely Active Crohn's Disease
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]
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
701EUCTR2016-001956-22-BE
(EUCTR)
25/01/201726/10/2016A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 1France;United States;Canada;Poland;Belgium;Germany
702EUCTR2016-000612-14-GB
(EUCTR)
25/01/201729/09/2016BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
286Phase 3Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
703EUCTR2015-001925-18-FI
(EUCTR)
25/01/201722/12/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
704NCT04272788
(ClinicalTrials.gov)
January 24, 201711/2/2020Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's DiseaseAssociation of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's DiseaseCrohn DiseaseDrug: InfliximabSecond Affiliated Hospital of Wenzhou Medical UniversityNULLCompleted18 YearsN/AAll32China
705EUCTR2016-002939-15-CZ
(EUCTR)
24/01/201701/11/2016A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease.A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - English A six week efficacy, safety and tolerability study of V565 in Crohn’s disease (HarbOR study) Active Crohn's Disease
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]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot RecruitingFemale: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
706EUCTR2016-002204-84-HU
(EUCTR)
19/01/201709/11/2016A Crohn's Disease studyA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) Crohn's Disease
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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of
707EUCTR2016-002939-15-GB
(EUCTR)
19/01/201724/07/2020A clinical study testing the efficacy and safety of V565 in patients with Crohn's DiseaseA Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). Active Crohn's Disease
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]
Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565
VHsquared LtdNULLNot RecruitingFemale: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
708EUCTR2016-003321-42-NL
(EUCTR)
18/01/201708/12/2016Stepwise extention of the adalimumab injection interval in patients with stable Crohn's disease.Lengthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients: the LADI study. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira (adalimumab)
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Radboud University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
709NCT02968108
(ClinicalTrials.gov)
January 18, 201724/10/2016A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseA Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: UstekinumabJanssen Research & Development, LLCNULLActive, not recruiting2 Years17 YearsAll45Phase 1United States;Belgium;Canada;France;Germany;Poland
710EUCTR2016-000612-14-DE
(EUCTR)
18/01/201705/09/2016BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. Moderately to severely active Crohn’s disease
MedDRA version: 20.0;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: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
711EUCTR2016-000634-21-PL
(EUCTR)
13/01/201711/10/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
654Phase 2France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of;United States;Ukraine;Russian Federation;United Kingdom;Italy
712EUCTR2015-001179-36-SK
(EUCTR)
13/01/201721/11/2016Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 Moderately to Severely Active Crohn's Disease
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]
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
713EUCTR2016-001956-22-PL
(EUCTR)
12/01/201701/12/2016A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 1United States;France;Canada;Belgium;Poland;Germany
714EUCTR2016-000678-40-BG
(EUCTR)
05/01/201701/11/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
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: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLNot RecruitingFemale: yes
Male: yes
385Phase 4Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of
715EUCTR2016-000522-18-DE
(EUCTR)
05/01/201701/08/2016Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Product Name: Methotrexat
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBD-NetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 3France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
716EUCTR2016-001367-36-GB
(EUCTR)
04/01/201719/12/2016A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden
717EUCTR2016-002763-34-GB
(EUCTR)
04/01/201721/12/2016A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden
718NCT03012542
(ClinicalTrials.gov)
January 20174/1/2017Diet as Essential Therapy (DIET) for Inflammatory Bowel DiseaseRandomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the MicrobiomeCrohn DiseaseDietary Supplement: Diet 1;Dietary Supplement: Diet 2University of WashingtonNULLUnknown status18 YearsN/AAll32N/AUnited States
719NCT03056664
(ClinicalTrials.gov)
January 201724/8/2015The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's DiseaseThe Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's DiseaseCrohn's Disease;FistulaProcedure: Routine drainage surgery;Biological: MSC injection 01;Biological: MSC injection 02;Other: placeboSixth Affiliated Hospital, Sun Yat-sen UniversityNULLNot yet recruiting18 Years65 YearsAll3Phase 2;Phase 3NULL
720NCT02862132
(ClinicalTrials.gov)
January 201731/7/2016Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel DiseasesPredicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseDrug: VedolizumabShaare Zedek Medical CenterNULLRecruitingN/A18 YearsAll120N/AUnited States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
721EUCTR2015-000555-24-FR
(EUCTR)
28/12/201603/01/2017Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Academic Medical Center AmsterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4France;Spain;Netherlands
722EUCTR2015-003759-23-DE
(EUCTR)
16/12/201625/05/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT 494) in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;New Zealand
723EUCTR2016-000612-14-CZ
(EUCTR)
14/12/201624/10/2016 BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
130Phase 3United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
724NCT02891226
(ClinicalTrials.gov)
December 14, 20161/9/2016A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's DiseaseA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)Crohn's DiseaseDrug: Mirikizumab;Drug: PlaceboEli Lilly and CompanyNULLActive, not recruiting18 Years75 YearsAll180Phase 2United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France
725NCT02976129
(ClinicalTrials.gov)
December 201623/11/2016A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's DiseasePhase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: V565;Drug: PlaceboVHsquared Ltd.NULLUnknown status18 Years80 YearsAll126Phase 2United States;Austria;Canada;Czechia;Germany;Hungary;Netherlands;Norway;Poland;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
726NCT02231814
(ClinicalTrials.gov)
December 201627/8/2014Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's DiseaseDietary Therapy Using Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet (CDED) for Induction and Maintenance of Remission in Mild to Moderate Crohn's Disease in Adults- A Pilot StudyCrohn's DiseaseDietary Supplement: Crohns Disease Exclusion Diet + PEN;Other: Crohns Disease Exclusion DietProf. Arie LevineNULLRecruiting18 Years55 YearsAll40N/AIsrael
727EUCTR2015-003759-23-GB
(EUCTR)
24/11/201624/05/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand
728NCT03183661
(ClinicalTrials.gov)
November 16, 20168/6/2017A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical TrialFollow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)Crohn DiseaseBiological: ALLO-ASC-CDAnterogen Co., Ltd.NULLEnrolling by invitation18 Years65 YearsAll9N/ANULL
729EUCTR2016-000634-21-GB
(EUCTR)
11/11/201603/08/2016 A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
654Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
730EUCTR2016-000634-21-HU
(EUCTR)
11/11/201612/09/2016 A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International NVNULLNot Recruiting Female: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
731EUCTR2016-000634-21-DE
(EUCTR)
08/11/201607/07/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
INN or Proposed INN: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
732EUCTR2015-003759-23-DK
(EUCTR)
04/11/201624/05/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;New Zealand
733EUCTR2015-003759-23-NL
(EUCTR)
03/11/201606/06/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT 494) in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand
734JPRN-UMIN000024566
2016/11/0101/11/2016Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. Crohn'diseaseDose escalation group
Administration of Adalimumab 80 mg every other week

Non-dose escalation group
Administration of Adalimumab 40 mg every other week
Toho University Medical Center Sakura HospitalNULLPending16years-oldNot applicableMale and Female60Not applicableJapan
735NCT02760615
(ClinicalTrials.gov)
November 1, 20162/5/2016Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction StudyAn Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: VedolizumabTakedaNULLWithdrawn18 Years55 YearsAll0Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
736NCT02998827
(ClinicalTrials.gov)
November 201624/11/2016Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD PatientsCrohn DiseaseDrug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutritionSixth Affiliated Hospital, Sun Yat-sen UniversityNULLEnrolling by invitationN/AN/AFemale90N/ANULL
737JPRN-UMIN000023735
2016/10/3131/10/2016Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE studyDoes changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study - TRADE study Crohn's diseaseEW or EOW injection of adalimumabSaitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete15years-old75years-oldMale and Female10Not selectedJapan
738EUCTR2016-002061-54-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
739EUCTR2015-003759-23-BE
(EUCTR)
11/10/201614/07/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
740EUCTR2015-000852-12-NL
(EUCTR)
05/10/201630/05/2016Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
126Phase 4France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
741NCT02956538
(ClinicalTrials.gov)
October 201613/10/2016Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using ThalidomideInduced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical StudyCrohn DiseaseDrug: Thalidomide;Drug: placebo(for thalidomide)Sixth Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting18 Years50 YearsBoth72Phase 0China
742EUCTR2016-003073-18-GB
(EUCTR)
29/09/201616/09/2016A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the bodyA Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Celgene International II SàrlNULLNot Recruiting Female: no
Male: yes
6Phase 1United Kingdom
743NCT02883452
(ClinicalTrials.gov)
September 29, 201625/8/2016A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative ColitisAn Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative ColitisCrohn's Disease;Ulcerative Colitis (Part 2 Only)Biological: CT-P13CelltrionNULLCompleted18 Years75 YearsAll181Phase 1Korea, Republic of
744NCT02871635
(ClinicalTrials.gov)
September 28, 201615/8/2016BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and ImmunogenicityBI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and ImmunogenicityCrohn DiseaseDrug: BI 695501;Drug: HUMIRABoehringer IngelheimNULLCompleted18 Years80 YearsAll147Phase 3United States;Belarus;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Israel;Poland;Russian Federation;Serbia;Turkey;Ukraine;United Kingdom
745EUCTR2015-001963-37-GR
(EUCTR)
28/09/201601/06/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
746EUCTR2014-004904-31-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
747EUCTR2015-003759-23-ES
(EUCTR)
19/09/201611/08/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Puerto Rico;Canada;Spain;Australia;Israel;New Zealand
748EUCTR2015-003759-23-SK
(EUCTR)
05/09/201623/06/2016A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;New Zealand
749NCT02820493
(ClinicalTrials.gov)
September 201617/5/2016Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNFEffectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease ProgressionCrohn DiseaseDrug: vedolizumabUniversita degli Studi di GenovaNULLWithdrawn18 Years80 YearsAll0Phase 4NULL
750NCT02877134
(ClinicalTrials.gov)
August 25, 201619/8/2016Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: UstekinumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll390Phase 2United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Czechia;Italy;Serbia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
751JPRN-UMIN000023871
2016/08/2501/09/2016Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) - Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) Crohn's diseaseAdministration of Adalimumab 80 mg every 2 weeks.
Administration of Adalimumab 40 mg every week.
Fukuoka University Chikushi HospitalNULLComplete: follow-up complete16years-oldNot applicableMale and Female100Not applicableJapan
752EUCTR2016-000678-40-EE
(EUCTR)
22/08/201620/06/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
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: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
385Phase 4Serbia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
753EUCTR2016-000678-40-LV
(EUCTR)
19/08/201610/05/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
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: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
754EUCTR2015-000555-24-ES
(EUCTR)
11/08/201615/07/2016Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Academic Medical Center AmsterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4Spain;Netherlands
755NCT02630966
(ClinicalTrials.gov)
August 10, 201611/12/2015Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)Crohn's DiseaseDrug: Vedolizumab;Drug: PlaceboTakedaNULLCompleted18 Years80 YearsAll34Phase 4United States;Canada;France;Italy;Netherlands;Spain;United Kingdom;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
756NCT02743806
(ClinicalTrials.gov)
August 1, 201615/4/2016Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's DiseaseEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: VedolizumabTakedaNULLActive, not recruiting18 Years90 YearsAll331Phase 4Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan
757NCT02897661
(ClinicalTrials.gov)
August 201614/8/2016Washed Microbiota Transplantation Improves Nutritional Status of Patients With Crohn's DiseaseWashed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' DiseaseCrohn's DiseasesProcedure: WMT;Dietary Supplement: EENThe Second Hospital of Nanjing Medical UniversityNULLRecruiting18 Years65 YearsAll30N/AChina
758NCT02641392
(ClinicalTrials.gov)
July 25, 201623/12/2015A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's DiseaseA Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: GED-0301;Other: PlaceboCelgeneNULLTerminated12 YearsN/AAll310Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Estonia;Finland;Malaysia;New Zealand;South Africa
759EUCTR2015-000852-12-ES
(EUCTR)
20/07/201620/07/2016NCT02630966 TITLE A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn?s Disease SUMMARY The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV. The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. - ENTERPRISE Fistulizing Crohn?s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
126Phase 4France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
760EUCTR2015-000481-58-NL
(EUCTR)
14/07/201615/02/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;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: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
761EUCTR2015-000852-12-FR
(EUCTR)
13/07/201615/03/2019Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
126Phase 4United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
762EUCTR2016-000205-36-DE
(EUCTR)
11/07/201614/03/2016A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD).A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis)
MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: FE 999301 University Hospital Schleswig-Holstein (UKSH)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Germany
763EUCTR2016-001638-84-NL
(EUCTR)
08/07/201617/05/2016Thiopurines with Low Dose Allopurinol: a prospective one way cross-over studyThiopurines with Low Dose Allopurinol: a prospective one way cross-over study - ThiLDA-study Crohn's disease & Colitis Ulcerosa;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Allopurinol Sandoz 100 mg, tabletten
INN or Proposed INN: ALLOPURINOL
INN or Proposed INN: ALLOPURINOL
Meander Medical CenterNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
764EUCTR2015-000852-12-GB
(EUCTR)
07/07/201630/03/2016Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom
765EUCTR2016-000678-40-HU
(EUCTR)
07/07/201619/05/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Hungary;Czech Republic;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
766JPRN-UMIN000019958
2016/07/0227/11/2015Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments Crohn's disease, ulcerative colitisPatients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
Iwate Medical UniversityKochi Medical School HospitalKeio University School of MedicineNULLComplete: follow-up continuing15years-oldNot applicableMale and Female100Not applicableJapan
767NCT02806206
(ClinicalTrials.gov)
July 201615/6/2016Prucalopride Prior to Small Bowel Capsule EndoscopyThe Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled TrialGastrointestinal Hemorrhage;Crohn Disease;Celiac Disease;Intestinal Diseases;Inflammatory Bowel DiseasesDrug: Prucalopride;Drug: PlaceboUniversity of British ColumbiaNULLNot yet recruiting19 YearsN/ABoth122Phase 4Canada
768EUCTR2015-000481-58-BE
(EUCTR)
30/06/201614/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;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: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
769JPRN-UMIN000022270
2016/06/3001/07/2016Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's diseaseEvaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease - ADA2 study Crohn's diseasedouble dose of adalimumabSaitama Medical CenterNULLComplete: follow-up complete15years-old80years-oldMale and Female20Not selectedJapan
770EUCTR2015-000482-31-BE
(EUCTR)
30/06/201614/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative Colitis Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
692Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
771EUCTR2016-000678-40-CZ
(EUCTR)
27/06/201618/05/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
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]
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
772EUCTR2015-001963-37-BG
(EUCTR)
23/06/201613/04/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
773EUCTR2015-000555-24-NL
(EUCTR)
16/06/201610/02/2016Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Academic Medical Center AmsterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4Netherlands
774EUCTR2015-000481-58-DE
(EUCTR)
14/06/201609/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
775EUCTR2015-000482-31-HR
(EUCTR)
13/06/201606/07/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
776EUCTR2016-001278-13-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
777EUCTR2015-001925-18-GR
(EUCTR)
01/06/201606/04/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3France;Australia;Denmark;Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
778EUCTR2015-000481-58-DK
(EUCTR)
31/05/201617/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;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: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
779EUCTR2015-000482-31-DK
(EUCTR)
31/05/201617/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
780EUCTR2015-000482-31-ES
(EUCTR)
29/05/201618/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn?s Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
781EUCTR2015-000481-58-ES
(EUCTR)
29/05/201620/04/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn?s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn?s Disease Crohn s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
824Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
782EUCTR2015-000482-31-NL
(EUCTR)
25/05/201627/01/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative Colitis Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
692Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
783NCT02782663
(ClinicalTrials.gov)
May 18, 201623/5/2016A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's DiseaseA Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's DiseaseCrohn's Disease (CD)Drug: ABT-494AbbVieNULLActive, not recruiting18 Years75 YearsAll107Phase 2United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Romania;Slovakia;Spain;United Kingdom
784EUCTR2015-002025-19-IT
(EUCTR)
17/05/201605/11/2020An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orallyA Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: RPC1063
Product Code: [RPC1063]
INN or Proposed INN: Ozanimod
Product Name: RPC0163
Product Code: [RPC0163]
INN or Proposed INN: Ozanimod
CELGENE INTERNATIONAL II SàRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine;Italy
785EUCTR2015-000609-38-DE
(EUCTR)
10/05/201628/01/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
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]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
786EUCTR2015-000482-31-HU
(EUCTR)
09/05/201622/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
787EUCTR2015-001925-18-HR
(EUCTR)
09/05/201606/07/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
788EUCTR2015-000481-58-HU
(EUCTR)
09/05/201622/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
789EUCTR2015-000482-31-DE
(EUCTR)
09/05/201609/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative Colitis Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
692Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
790EUCTR2015-001963-37-HR
(EUCTR)
05/05/201621/06/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
791EUCTR2015-000482-31-LT
(EUCTR)
04/05/201618/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Colombia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden;Australia;Bosnia and Herzegovina;Russian Federation;Italy
792EUCTR2015-000481-58-LT
(EUCTR)
04/05/201618/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
793EUCTR2015-001963-37-BE
(EUCTR)
03/05/201610/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
794ChiCTR-OPC-16008655
2016-05-012016-06-16Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from ChinaEfficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China Crohn‘s Disease1:Thalidomide 75-100mg qd;2:Thalidomide 150-200mg qd;3:Thalidomide 75-100mg qd+MTX 20-25mg /W;Peking Union Medical College HospitalNULLRecruiting1670Both1:90;2:90;3:90;China
795EUCTR2015-000609-38-BE
(EUCTR)
21/04/201625/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UKNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
796EUCTR2015-001925-18-BG
(EUCTR)
20/04/201618/03/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
797EUCTR2015-004618-10-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
798NCT02620046
(ClinicalTrials.gov)
April 15, 201619/11/2015Vedolizumab Subcutaneous Long-Term Open-Label Extension StudyA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: Vedolizumab SCTakedaNULLActive, not recruiting18 Years80 YearsAll692Phase 3United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic
799EUCTR2015-001963-37-DK
(EUCTR)
15/04/201622/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Sweden;Norway;Germany;New Zealand;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria
800JPRN-JapicCTI-163220
15/4/201608/04/2016Vedolizumab Subcutaneous Long-Term Open-Label Extension StudyA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease Ulcerative colitis or Crohn's diseaseIntervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to disease worsening or need for rescue medications will receive vedolizumab SC 108 mg QW.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLcomplete1880BOTH692Phase 3Japan, Refer to Othersection
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
801EUCTR2015-001925-18-SK
(EUCTR)
14/04/201630/11/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
802EUCTR2015-001963-37-SK
(EUCTR)
14/04/201607/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
803EUCTR2015-000481-58-CZ
(EUCTR)
13/04/201621/01/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
804EUCTR2015-000482-31-CZ
(EUCTR)
13/04/201621/01/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
805EUCTR2015-001249-10-IS
(EUCTR)
12/04/201602/03/2016An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Germany;Iceland;United Kingdom;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
806NCT02749630
(ClinicalTrials.gov)
April 11, 201612/4/2016A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.NULLCompleted18 Years80 YearsAll70Phase 1Germany;United Kingdom;Canada
807EUCTR2015-001963-37-ES
(EUCTR)
08/04/201603/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn?s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn?s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
808NCT02750800
(ClinicalTrials.gov)
April 7, 201613/4/2016Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUERheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative ColitisBiological: Adalimumab;Behavioral: AbbVie Care 2.0AbbVieNULLCompleted18 Years99 YearsAll427Hungary
809EUCTR2015-000482-31-SE
(EUCTR)
05/04/201616/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
810EUCTR2015-000481-58-SE
(EUCTR)
05/04/201617/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
824Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
811NCT02685683
(ClinicalTrials.gov)
April 4, 201615/2/2016Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's DiseaseA Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: GED-0301CelgeneNULLTerminated18 YearsN/AAll18Phase 2Italy
812EUCTR2015-000609-38-HU
(EUCTR)
04/04/201624/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
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]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
813JPRN-UMIN000020029
2016/04/0101/12/2015The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infectionThe significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more.Saitama Medical UniversityNULLRecruiting16years-oldNot applicableMale and Female300Not selectedJapan
814EUCTR2015-001925-18-CZ
(EUCTR)
01/04/201622/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
815EUCTR2015-001963-37-CZ
(EUCTR)
01/04/201622/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn's disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
816EUCTR2015-000481-58-BG
(EUCTR)
31/03/201616/02/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;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: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
817EUCTR2015-000609-38-BG
(EUCTR)
30/03/201615/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
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]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
Allergan LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
818EUCTR2015-001963-37-PT
(EUCTR)
28/03/201610/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
819EUCTR2015-001925-18-PT
(EUCTR)
28/03/201610/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
820EUCTR2015-001925-18-BE
(EUCTR)
25/03/201620/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Serbia;Portugal;United States;Estonia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
821EUCTR2015-000609-38-NL
(EUCTR)
24/03/201602/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - MEDI2070-LUX Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UKNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
822EUCTR2015-001963-37-IT
(EUCTR)
23/03/201623/02/2018A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: Mongersen
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
823EUCTR2015-000482-31-BG
(EUCTR)
23/03/201616/02/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
824EUCTR2015-000482-31-GB
(EUCTR)
21/03/201608/03/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
825EUCTR2015-001963-37-GB
(EUCTR)
15/03/201629/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;United States;Serbia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Pakistan;Finland;Oman;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
826EUCTR2015-000481-58-GB
(EUCTR)
14/03/201608/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’ Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
827EUCTR2012-002702-51-NO
(EUCTR)
07/03/201603/02/2016Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled studyDiscontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 18.1;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: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
Trade Name: Inflectra
Product Name: Inflectra
Product Code: EMEA/H/C/002778
Department of medical gastroenterology, Herlev HospitalNULLNot RecruitingFemale: yes
Male: yes
136Phase 4Finland;Denmark;Norway;Sweden
828EUCTR2015-001925-18-ES
(EUCTR)
07/03/201604/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn?s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
829EUCTR2015-001925-18-DK
(EUCTR)
04/03/201606/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
830EUCTR2015-000609-38-IT
(EUCTR)
04/03/201621/02/2018A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to SevereCrohn's Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - nd Crohn's Disease
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]
Product Name: MEDI2070
Product Code: MEDI2070
Other descriptive name: anticorpo monoclonale anti-IL-23
MEDIMMUNE, LLCNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
831NCT02769494
(ClinicalTrials.gov)
March 20169/3/2016The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral UlcerThe Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's DiseaseCrohn's Disease;Oral UlcerDrug: Mesalazine Sustained-Release Tablets;Drug: Riboflavin Sodium Phosphate InjectionXijing Hospital of Digestive DiseasesNULLRecruiting18 Years65 YearsBoth40Phase 3China
832NCT02538354
(ClinicalTrials.gov)
March 201620/8/2015The Effect of Riboflavin in Crohn's DiseaseThe Effect of Riboflavin Supplementation on Faecalibacterium Prausnitzii in Crohn's DiseaseCrohn DiseaseDietary Supplement: Riboflavin supplementationUniversity Medical Center GroningenNULLCompleted18 Years65 YearsAll70N/ANetherlands
833EUCTR2015-000609-38-ES
(EUCTR)
29/02/201608/02/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn?s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UKNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
834EUCTR2015-001963-37-DE
(EUCTR)
26/02/201611/01/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
835EUCTR2015-001925-18-GB
(EUCTR)
24/02/201618/11/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety o Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
836EUCTR2015-001963-37-LV
(EUCTR)
18/02/201601/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
837EUCTR2015-001925-18-LV
(EUCTR)
18/02/201601/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
838EUCTR2015-000609-38-CZ
(EUCTR)
15/02/201629/01/2016A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha TherapyA Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody
MedImmune LimitedNULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
839EUCTR2015-001963-37-HU
(EUCTR)
15/02/201617/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
840EUCTR2015-001925-18-HU
(EUCTR)
15/02/201617/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
841EUCTR2015-001963-37-SE
(EUCTR)
10/02/201617/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
842EUCTR2015-001925-18-DE
(EUCTR)
09/02/201607/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
843EUCTR2015-001925-18-AT
(EUCTR)
29/01/201622/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
844EUCTR2015-001963-37-AT
(EUCTR)
29/01/201622/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
845EUCTR2015-002025-19-PL
(EUCTR)
28/01/201621/12/2015An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orallyA Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 0.25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
846EUCTR2015-001925-18-SE
(EUCTR)
27/01/201625/11/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
847NCT02925351
(ClinicalTrials.gov)
January 25, 20168/9/2016Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory DiseasesThe Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory DiseasesAutoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu ArteritisProcedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission TomographyJonsson Comprehensive Cancer CenterNULLCompleted18 YearsN/AAll8Early Phase 1United States
848EUCTR2015-000482-31-SK
(EUCTR)
22/01/201605/01/2016Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's DiseaseA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: ENTYVIO
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
692Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
849EUCTR2015-000481-58-SK
(EUCTR)
22/01/201605/01/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
850EUCTR2015-001678-17-NL
(EUCTR)
14/01/201614/01/2016A Pilot Study of FFP104 in Subjects with Crohn’s DiseaseA Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects with Moderate to Severely Active Crohn’s Disease Moderate to Severely Active Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: FFP104Fast Forward Pharmaceuticals, B.V.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Belgium;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
851NCT02574637
(ClinicalTrials.gov)
January 5, 201624/9/2015Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's DiseaseA Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha TherapyCrohn's DiseaseDrug: Brazikumab IV Infusion;Drug: Brazikumab SC Injection;Drug: PlaceboAllerganNULLTerminated18 Years80 YearsAll29Phase 2United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Russian Federation;Spain;Bulgaria;Czech Republic;Korea, Republic of;Poland;Turkey;United Kingdom
852JPRN-JapicCTI-163386
04/1/201628/09/2016Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy Crohn's DiseaseIntervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50
Takeda Pharmaceutical Company LimitedNULLcomplete1880BOTH644Phase 3Japan, Refer to Othersection
853NCT02611817
(ClinicalTrials.gov)
January 4, 201619/11/2015Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous TherapyCrohn's DiseaseDrug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mgTakedaNULLCompleted18 Years80 YearsAll644Phase 3United States;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic;Spain
854ChiCTR-IIR-16007751
2016-01-012016-01-13Clinical study of acupuncture and moxibustion treatment for Cohn's diseaseMolecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease Crohn's diseaseAcupuncture Group:Acupuncture, Moxibustion, Prednisone and azathioprine;Placebo acupuncture group:Placebo acupuncture, moxibustion, Prednisone and azathioprine;Drug Group:Prednisone and azathioprine;Shanghai Research Institute of Acupuncture and MeridianNULLRecruiting1670BothAcupuncture Group:40;Placebo acupuncture group:40;Drug Group:40;I (Phase 1 study)China
855ChiCTR1800020305
2016-01-012018-12-23A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's diseaseInfliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI crohn's disease;K50.900Group 2:infliximab + azathioprine;Group 1:infliximab alone;Department of Gastroenterology, Nanfang Hospital, Southern Medical UniversityNULLRecruiting1280BothGroup 2:41;Group 1:45;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
856NCT02532738
(ClinicalTrials.gov)
January 201623/8/2015The Efficiency of MSC in Refractory Crohn's DiseaseA Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's DiseaseCrohn's DiseaseDrug: Routine Treatment of CD;Biological: MSC treatment 01;Biological: MSC treatment 02;Other: NSSixth Affiliated Hospital, Sun Yat-sen UniversityThird Affiliated Hospital, Sun Yat-Sen University;Nanfang Hospital of Southern Medical UniversityNot yet recruiting18 Years65 YearsBoth3Phase 2;Phase 3NULL
857NCT02680756
(ClinicalTrials.gov)
January 20169/2/2016Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBDA Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel DiseaseAnemia, Iron-Deficiency;Inflammatory Bowel Disease;Crohn's DiseaseDrug: Ferric Maltol;Drug: Ferric Carboxy MaltoseShield TherapeuticsNULLCompleted18 YearsN/AAll250Phase 3United States;Belgium;France;Germany;Hungary;Spain
858NCT02465944
(ClinicalTrials.gov)
January 201618/5/2015A Pilot Study of FFP104 in Subjects With Crohn's DiseaseA Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects With Moderate to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: FFP104;Drug: PlaceboFast Forward PharmaceuticalsNULLRecruiting18 Years75 YearsBoth24Phase 1;Phase 2Belgium;Netherlands
859EUCTR2015-002025-19-HU
(EUCTR)
30/12/201529/10/2015An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine
860EUCTR2015-001925-18-EE
(EUCTR)
29/12/201507/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
861EUCTR2015-001963-37-EE
(EUCTR)
29/12/201507/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
862EUCTR2015-001249-10-GB
(EUCTR)
11/12/201506/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;Italy;New Zealand;United Kingdom
863NCT02596893
(ClinicalTrials.gov)
December 8, 20153/11/2015Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's DiseaseCrohn DiseaseDrug: GED-0301;Drug: PlaceboCelgeneNULLTerminated18 YearsN/AAll701Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Former Serbia and Montenegro;South Africa
864NCT02678052
(ClinicalTrials.gov)
December 1, 20154/2/2016OTIS Vedolizumab Pregnancy Exposure RegistryOrganization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure RegistryColitis, Ulcerative;Crohn's DiseaseDrug: Vedolizumab;Biological: Other Biological AgentTakedaNULLActive, not recruiting18 Years44 YearsFemale300United States;Canada
865EUCTR2015-001678-17-BE
(EUCTR)
01/12/201510/09/2015A Pilot Study of FFP104 in Subjects with Crohn’s DiseaseA Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects with Moderate to Severely Active Crohn’s Disease Moderate to Severely Active Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: FFP104Fast Forward Pharmaceuticals, B.V.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Belgium;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
866NCT02620007
(ClinicalTrials.gov)
December 201530/11/2015Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn DiseaseMulticenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn DiseaseCrohn Disease;Adherent-invasive E. ColiDrug: Ciprofloxacin;Drug: Rifaximin;Drug: Ciprofloxacin Placebo;Drug: Rifaximin PlaceboAssistance Publique - Hôpitaux de ParisNULLRecruiting18 Years80 YearsAll62Phase 2France
867NCT02636517
(ClinicalTrials.gov)
December 201516/12/2015Fecal Microbiome TransplantFecal Microbiome Transplant in Pediatric C. DifficileClostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisBiological: Fecal Microbiota TransplantChildren's Hospital of PhiladelphiaNULLActive, not recruiting3 Years21 YearsAll50N/AUnited States
868EUCTR2014-003240-12-NL
(EUCTR)
27/11/201521/04/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
869EUCTR2014-002311-41-DE
(EUCTR)
25/11/201521/08/2015A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapyA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy - SPARE Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4France;Australia;Netherlands;Germany;United Kingdom;Sweden
870EUCTR2015-001249-10-IT
(EUCTR)
11/11/201521/02/2018An investigational study to assess the safety and effectiveness of a newinvestgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, MulticenterStudy Evaluating the Safety and Efficacy of GS-5745 in Subjects withModerately to Severely Active Crohn's Disease - GS-US-395-1663 Crohn's Disease
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]
Product Name: GS-5745
Product Code: nessuno
GILEAD SCIENCES INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
871EUCTR2015-001249-10-DE
(EUCTR)
02/11/201514/08/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
872NCT02330653
(ClinicalTrials.gov)
November 201529/12/2014Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's ColitisA Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's ColitisInflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseBiological: Fecal Microbiota Transplant (FMT);Biological: PlaceboStacy A. KahnNULLCompleted5 Years30 YearsAll15Phase 1;Phase 2United States
873NCT02622763
(ClinicalTrials.gov)
November 20151/12/2015Intralesional Tolerogenic Dendritic Cells in Crohn's Disease TreatmentSafety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's DiseaseCrohn's DiseaseBiological: Tolerogenic Dendritic CellsFundacion Clinic per a la Recerca BiomédicaNULLTerminated18 Years65 YearsAll3Phase 1Spain
874NCT02926300
(ClinicalTrials.gov)
November 201511/11/2015Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's DiseaseCrohn's DiseaseBiological: stem cellsKang Stem Biotech Co., Ltd.NULLRecruiting19 Years70 YearsAll24Phase 1;Phase 2aKorea, Republic of
875EUCTR2015-001834-15-NL
(EUCTR)
30/10/201511/08/2015A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's diseaseAn open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655066 10 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
62Phase 2United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
876EUCTR2014-003240-12-NO
(EUCTR)
19/10/201508/04/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
877EUCTR2014-005666-29-GB
(EUCTR)
16/10/201511/09/2015A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's diseaseA Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease. - A study of Thetanix in young people with stable Crohn's disease Crohn's disease in young persons
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]
4D PharmaNULLNot Recruiting Female: yes
Male: yes
18Phase 1United Kingdom
878EUCTR2014-004108-31-CZ
(EUCTR)
13/10/201502/06/2015Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU Moderately Active Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3United Kingdom;Hungary;Czech Republic;Ukraine;Ireland;Russian Federation
879EUCTR2012-002702-51-FI
(EUCTR)
12/10/201530/09/2015Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled studyDiscontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 18.0;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: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB
Department of medical gastroenterology, Herlev HospitalNULLNot RecruitingFemale: yes
Male: yes
5Phase 4Finland;Denmark;Norway;Sweden
880NCT02531113
(ClinicalTrials.gov)
October 9, 201520/8/2015Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's DiseaseA Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction TherapyCrohn's DiseaseDrug: RPC1063CelgeneNULLCompleted18 Years75 YearsAll69Phase 2United States;Canada;Hungary;Poland;Ukraine;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
881EUCTR2014-003509-13-BE
(EUCTR)
06/10/201510/07/2015Effect of Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease
MedDRA version: 18.0;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: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Hungary;Canada;Poland;Belgium
882EUCTR2015-001249-10-CZ
(EUCTR)
01/10/201514/08/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Hungary;Czech Republic;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
883NCT02520843
(ClinicalTrials.gov)
October 20155/8/2015An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVFAn Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular FractionCrohn DiseaseDrug: stromal vascular fraction (SVF)Assistance Publique Hopitaux De MarseilleNULLCompleted18 YearsN/AAll10Phase 1;Phase 2France
884EUCTR2013-003199-11-BE
(EUCTR)
25/09/201527/07/2015CUREChanging the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURE Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Adalimumab
Product Name: Humira
GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires DigestivesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4France;Belgium
885EUCTR2015-001834-15-ES
(EUCTR)
24/09/201518/06/2015A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's diseaseAn open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease Crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Boehringer Ingelheim España, S.A.NULLNot Recruiting Female: yes
Male: yes
62Phase 2United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
886EUCTR2015-001834-15-DE
(EUCTR)
24/09/201514/08/2015A long term extension trial of BI 655066/ABBV-066 (risankizumab) in patients with moderately to severely active Crohn's diseaseAn open label, single group, long term safety extension trial of BI 655066/ABBV-066 (risankizumab), in patients with moderately to severely active Crohn's disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
62Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
887EUCTR2015-001249-10-HU
(EUCTR)
22/09/201510/08/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
888EUCTR2015-001249-10-ES
(EUCTR)
16/09/201511/09/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn?s Disease Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
889EUCTR2015-001954-14-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
890EUCTR2014-003824-36-DE
(EUCTR)
10/09/201525/03/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
891EUCTR2014-003855-76-DE
(EUCTR)
09/09/201525/03/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
892EUCTR2014-003855-76-NL
(EUCTR)
03/09/201516/04/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
893EUCTR2014-003824-36-NL
(EUCTR)
03/09/201502/04/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
894EUCTR2015-001834-15-BE
(EUCTR)
01/09/201501/07/2015A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's diseaseAn open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
62Phase 2United States;Canada;Spain;Belgium;Germany;Netherlands;Korea, Republic of
895NCT02522169
(ClinicalTrials.gov)
September 20153/5/2015TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's DiseaseVerbessertes Therapiemanagement für pädiatrische CED-Patienten Mit Chronisch-entzündlicher Darmerkrankung: Eine Randomisierte Multizentrische Studie, Welche Die Effektivität Einer Talspiegel-gesteuerten Infliximab-Erhaltungsphase Mit Dem herkömmlichen Dosierungsregime Vergleicht Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Randomized Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's DiseasePediatric Crohns DiseaseDrug: InfliximabKlinikum Westbrandenburg GmbHNULLNot yet recruiting6 Years17 YearsBoth120N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
896NCT03010787
(ClinicalTrials.gov)
September 201512/12/2016A First Time in Human Study in Healthy Volunteers and PatientsA Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal IleostomyCrohn's DiseaseDrug: V565;Drug: PlaceboVHsquared Ltd.NULLCompleted18 Years65 YearsAll47Phase 1United Kingdom
897EUCTR2014-004108-31-HU
(EUCTR)
27/08/201528/04/2015Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU Moderately Active Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Slovakia;Belgium;Spain;Ukraine;Ireland;Russian Federation;Netherlands;Germany;United Kingdom
898EUCTR2014-003240-12-PL
(EUCTR)
21/08/201509/06/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators orAnti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
899EUCTR2014-002311-41-SE
(EUCTR)
21/08/201501/07/2015A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapyA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Imurel 25 mg
Product Name: Imurel
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE
Trade Name: Puri-Nethol 50 mg
Product Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Metoject
Product Name: Metotrexat
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 4France;Netherlands;Germany;United Kingdom;Sweden
900EUCTR2014-003509-13-PL
(EUCTR)
18/08/201512/06/2015Effect of Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease
MedDRA version: 19.0;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: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Hungary;Canada;Belgium;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
901NCT02499783
(ClinicalTrials.gov)
August 17, 201514/7/2015Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive ProteinCrohn's DiseaseBiological: adalimumab;Other: placeboAbbVieNULLCompleted18 Years70 YearsAll205Phase 3China
902EUCTR2014-003855-76-SE
(EUCTR)
12/08/201527/01/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
903EUCTR2014-003824-36-SE
(EUCTR)
12/08/201527/01/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
904EUCTR2012-002702-51-SE
(EUCTR)
10/08/201510/06/2015Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled studyDiscontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
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: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
Department of medical gastroenterology S, Odense University HospitalNULLNot RecruitingFemale: yes
Male: yes
136Phase 4Finland;Denmark;Norway;Sweden
905EUCTR2014-004887-39-PL
(EUCTR)
08/08/201507/07/2015A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., LtdNULLNot RecruitingFemale: yes
Male: yes
Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
906NCT02538679
(ClinicalTrials.gov)
August 7, 201520/8/2015A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block TechniquesA Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal SurgeryCrohn's Disease;Inflammatory Bowel Disease;Postoperative PainOther: Placebo;Drug: US TAP Bupivacaine/Epinephrine;Drug: Lap TAP Bupivacaine/EpinephrineCedars-Sinai Medical CenterNULLCompleted18 Years90 YearsAll127N/ANULL
907EUCTR2014-003824-36-RO
(EUCTR)
05/08/201505/10/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Croatia;Romania;Germany;New Zealand;Sweden
908NCT02389790
(ClinicalTrials.gov)
August 201510/3/2015Extension Study of MT-1303 in Subjects With Crohn's DiseaseA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 StudyCrohn's DiseaseDrug: MT-1303Mitsubishi Tanabe Pharma CorporationNULLCompleted18 Years65 YearsAll46Phase 2Czechia;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine;Czech Republic
909NCT02452151
(ClinicalTrials.gov)
August 201520/5/2015Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR TrialSanteon InflixMab biosimILAr Research A 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.Colitis, Ulcerative;Crohn's DiseaseDrug: Infliximab-Biosimilar;Drug: Infliximab-InnovatorOnze Lieve Vrouwe GasthuisSanteonNot yet recruiting18 YearsN/ABoth300Phase 4NULL
910EUCTR2014-003855-76-BE
(EUCTR)
29/07/201519/05/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
911EUCTR2015-001179-36-PL
(EUCTR)
24/07/201501/06/2015Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn's Disease
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]
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
912EUCTR2014-003824-36-BE
(EUCTR)
17/07/201527/05/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
913EUCTR2014-003240-12-IT
(EUCTR)
16/07/201528/02/2018A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. - n/a Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLNot Recruiting Female: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
914EUCTR2014-002311-41-GB
(EUCTR)
14/07/201530/06/2015A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapyA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy (SPARE) - SPARE Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Remicade
Product Name: INFLIXIMAB
Trade Name: Imuran
Product Name: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Mercaptopurine
Product Name: Mercaptopurine
University of EdinburghNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300France;Belgium;Germany;United Kingdom;Sweden
915EUCTR2014-003824-36-LV
(EUCTR)
02/07/201526/02/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
916EUCTR2014-003855-76-LV
(EUCTR)
02/07/201502/03/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
917NCT02269358
(ClinicalTrials.gov)
July 201530/9/2014Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose EscalationPhase 4, Open Lable Non Randomized un Controlled Study. Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose EscalationCrohn's DiseaseDrug: METHOTREXATEProf. Arie LevineNULLCompleted8 Years18 YearsAll22Phase 4Israel
918EUCTR2014-003855-76-AT
(EUCTR)
30/06/201526/05/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
919EUCTR2014-005376-29-NL
(EUCTR)
29/06/201508/01/2015An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.An open-label observational phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: EntyvioAcademic Medical Center, GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 4Netherlands
920EUCTR2014-003509-13-CZ
(EUCTR)
25/06/201527/04/2015Effect of Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease
MedDRA version: 20.0;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: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Czech Republic;Canada;Belgium;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
921EUCTR2012-004222-25-GR
(EUCTR)
25/06/201526/06/2015Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseA 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 2;Phase 3United States;Morocco;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Tunisia
922EUCTR2014-003240-12-ES
(EUCTR)
24/06/201527/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
923EUCTR2014-003855-76-HR
(EUCTR)
24/06/201501/10/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
924EUCTR2014-003824-36-HR
(EUCTR)
24/06/201501/10/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
925EUCTR2014-003824-36-SK
(EUCTR)
23/06/201504/05/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA Phase III, Randomized, Double-Blind, Placebo-Controlled, MulticenterStudy to Evaluate the Efficacy and Safety of Etrolizumab as an Inductionand Maintenance Treatment for Patients with Moderately to Severely ActiveCrohn´s Disease Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
926EUCTR2014-003855-76-SK
(EUCTR)
23/06/201507/05/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAn open-label extension and safety monitoring study of patients with moderately to severely active Crohn`s disease previously enrolled in the Etrolizumab phase III protocol GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden
927EUCTR2014-003240-12-DE
(EUCTR)
22/06/201525/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
928EUCTR2014-003240-12-SK
(EUCTR)
22/06/201509/04/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
929EUCTR2014-003240-12-BE
(EUCTR)
19/06/201518/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
930EUCTR2014-003855-76-HU
(EUCTR)
15/06/201523/03/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
931EUCTR2014-003824-36-HU
(EUCTR)
15/06/201523/03/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
932EUCTR2014-001050-41-DE
(EUCTR)
12/06/201515/12/2014Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease - REACT2 Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira
Product Name: Humira
Robarts Clinical TrialsNULLNot RecruitingFemale: yes
Male: yes
1200Phase 4United States;Canada;Germany;United Kingdom
933EUCTR2014-003240-12-DK
(EUCTR)
10/06/201531/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Denmark;Australia;Norway;Netherlands;Germany;New Zealand;Sweden
934NCT02403323
(ClinicalTrials.gov)
June 8, 201526/3/2015Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144Crohn DiseaseDrug: EtrolizumabHoffmann-La RocheNULLRecruiting18 YearsN/AAll900Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Luxembourg;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic
935EUCTR2013-004034-15-BE
(EUCTR)
04/06/201505/01/2015A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
936EUCTR2014-005376-29-BE
(EUCTR)
02/06/201503/02/2015An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Academic Medical Center, GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 4Belgium;Netherlands
937EUCTR2014-001645-24-PL
(EUCTR)
29/05/201506/05/2015 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
938EUCTR2014-003824-36-AT
(EUCTR)
27/05/201521/04/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
939EUCTR2014-003855-76-ES
(EUCTR)
27/05/201527/03/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Roche Farma S.A. en nombre de F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Switzerland;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Latvia;New Zealand;Korea, Republic of
940EUCTR2014-003824-36-ES
(EUCTR)
27/05/201527/03/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE Crohn`s Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Roche Farma S.A en nombre de F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Lithuania;Turkey;Austria;Russian Federation;Israel;Switzerland;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Latvia;New Zealand;Korea, Republic of;Serbia;United States;Estonia;Slovakia;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
941EUCTR2014-003824-36-CZ
(EUCTR)
20/05/201531/03/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Mexico;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden
942EUCTR2014-004904-31-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
943EUCTR2014-003509-13-HU
(EUCTR)
15/05/201513/04/2015Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Hungary;Canada;Belgium;Poland
944EUCTR2010-020137-10-LT
(EUCTR)
13/05/201512/03/2015Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
945EUCTR2014-003855-76-CZ
(EUCTR)
11/05/201512/05/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
946EUCTR2014-003240-12-HU
(EUCTR)
11/05/201525/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
947EUCTR2013-004034-15-FR
(EUCTR)
07/05/201522/06/2015 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
948EUCTR2014-003240-12-CZ
(EUCTR)
04/05/201507/05/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT- 494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
949NCT02256462
(ClinicalTrials.gov)
May 1, 201526/9/2014Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) TrialPediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) TrialCrohn's DiseaseDrug: AdalimumabSchneider Children's Medical Center, IsraelNULLCompleted6 Years17 YearsAll82Phase 4Israel
950NCT02575040
(ClinicalTrials.gov)
May 20156/10/2015Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseEfficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel DiseaseUlcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction)Biological: Fecal microbiota transplantationGulhane Military Medical AcademyNULLRecruiting18 YearsN/ABoth60Phase 3Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
951NCT02413047
(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
952NCT02405442
(ClinicalTrials.gov)
April 30, 201527/3/2015Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Andecaliximab;Drug: PlaceboGilead SciencesNULLTerminated18 Years75 YearsAll187Phase 2United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Czech Republic;Iceland
953EUCTR2014-003855-76-FR
(EUCTR)
17/04/201525/06/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Switzerland;France;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Latvia;New Zealand;Korea, Republic of
954EUCTR2014-003824-36-FR
(EUCTR)
17/04/201525/06/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Croatia;Germany;New Zealand;Sweden
955EUCTR2014-003855-76-EE
(EUCTR)
15/04/201517/02/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
956EUCTR2014-003824-36-EE
(EUCTR)
15/04/201517/02/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's diseaseA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
957EUCTR2014-003855-76-LT
(EUCTR)
10/04/201518/02/2015An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
958EUCTR2014-003824-36-LT
(EUCTR)
10/04/201518/02/2015A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Crohn`s Disease
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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1150Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
959EUCTR2014-002557-19-NL
(EUCTR)
10/04/201503/11/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy
960EUCTR2014-005702-37-NL
(EUCTR)
08/04/201512/02/2015Early infliximab use in kids with Crohn's disease (TISKids)Top-Down Infliximab Study in Kids with Crohn's disease (TISKids) - Top-down Infliximab in Kids with Crohn's disease (TISKids) Crohn's disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Inflectra
Erasmus Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
961NCT02367183
(ClinicalTrials.gov)
April 8, 201513/2/2015A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's DiseaseA Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease.Crohn DiseaseDrug: GED-0301;Drug: PlaceboCelgeneNULLCompleted18 YearsN/AAll64Phase 1United States;Australia;Canada;Hungary;Slovakia
962NCT02675153
(ClinicalTrials.gov)
April 1, 201521/1/2016To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related StrictureEfficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related StrictureCrohn's DiseasesDrug: RapamycinThe Second Hospital of Nanjing Medical UniversityNULLRecruiting18 YearsN/AAll15N/AChina
963NCT02851134
(ClinicalTrials.gov)
April 20157/6/2016Search for New Genetic Mutations Major Effect in Crohn's DiseaseSearch for New Genetic Mutations Major Effect in Crohn's DiseaseCrohn DiseaseGenetic: genetic analysis;Biological: blood and stools samplesUniversity Hospital, LilleNULLCompleted5 Years80 YearsAll20France
964NCT02580617
(ClinicalTrials.gov)
April 201515/10/2015A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's DiseaseA Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's DiseaseCrohn's DiseaseBiological: ALLO-ASCAnterogen Co., Ltd.NULLUnknown status18 Years65 YearsAll9Phase 1Korea, Republic of
965NCT02674308
(ClinicalTrials.gov)
March 31, 201529/1/2016Entyvio (Vedolizumab) Long Term Safety StudyEntyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis and Crohn's DiseaseDrug: Vedolizumab;Other: Other Biologic AgentsTakedaNULLActive, not recruiting18 YearsN/AAll5302United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
966EUCTR2013-004034-15-IT
(EUCTR)
31/03/201503/10/2014 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
967EUCTR2014-002557-19-PL
(EUCTR)
30/03/201521/01/2015A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
968EUCTR2014-002556-77-PL
(EUCTR)
30/03/201520/01/2015A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
969NCT02425111
(ClinicalTrials.gov)
March 30, 201526/3/2015Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IVCrohn's DiseaseDrug: VedolizumabTakedaNULLCompleted18 Years80 YearsAll101Phase 3United States;Belgium;Canada;Czechia;France;Hungary;Italy;Poland;Czech Republic
970EUCTR2014-002556-77-NL
(EUCTR)
26/03/201503/11/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
971NCT02394028
(ClinicalTrials.gov)
March 20, 201527/2/2015A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's DiseaseA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Placebo;Drug: EtrolizumabHoffmann-La RocheNULLRecruiting18 Years80 YearsAll1150Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Luxembourg;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic
972NCT03306446
(ClinicalTrials.gov)
March 17, 201521/6/2015Changing the coUrse of cRohn's Disease With an Early Use of AdalimumabChanging the coUrse of cRohn's Disease With an Early Use of AdalimumabCDDrug: Start adalimumab in monotherapyGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLActive, not recruiting18 Years75 YearsAll203Phase 4Belgium;France
973NCT02365649
(ClinicalTrials.gov)
March 17, 201516/2/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF TherapyCrohn's DiseaseDrug: ABT-494;Drug: PlaceboAbbVieNULLCompleted18 Years75 YearsAll219Phase 2United States;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Romania;Slovakia;Spain;United Kingdom;Czech Republic;Sweden
974EUCTR2014-001644-38-PL
(EUCTR)
13/03/201530/12/2014 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
975EUCTR2013-004034-15-DK
(EUCTR)
06/03/201527/10/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 19.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
976NCT01836289
(ClinicalTrials.gov)
March 201517/4/2013High-dose Cyclophosphamide for Severe Refractory Crohn DiseaseHigh-dose Cyclophosphamide for Severe Refractory Crohn DiseaseCrohn's Disease;Crohn DiseaseDrug: High-dose CyclophosphamideJohns Hopkins UniversityNULLWithdrawn18 Years100 YearsAll0Phase 1;Phase 2United States
977NCT02378688
(ClinicalTrials.gov)
March 201527/2/2015Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseDrug: MT-1303;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNULLCompleted18 Years65 YearsBoth78Phase 2Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine
978NCT02392286
(ClinicalTrials.gov)
March 201512/3/2015Corticosteroid Dosage for Crohn's Disease FlareA Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease FlaresCrohn's Disease;Inflammatory Bowel DiseaseDrug: CorticosteroidYale UniversityNULLTerminated18 YearsN/AAll15Phase 4United States
979EUCTR2013-002902-29-NL
(EUCTR)
12/02/201525/02/2014Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: BI 655066 10 mg/ml
Product Code: BI 655066 10 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Product Name: BI 655066 90 mg/ml
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of
980EUCTR2014-001645-24-DE
(EUCTR)
09/02/201501/10/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
981EUCTR2013-004034-15-DE
(EUCTR)
09/02/201529/08/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
982EUCTR2014-001644-38-DE
(EUCTR)
02/02/201518/09/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
983NCT02061163
(ClinicalTrials.gov)
February 20156/2/2014Contrast-Enhanced Ultrasound in Human Crohn's DiseaseEvaluation of Contrast-Enhanced Ultrasound in Human Crohn's DiseaseCrohn's DiseaseDevice: Contrast Enhanced Ultrasound;Drug: OptisonUniversity of MichiganNULLWithdrawn10 YearsN/ABoth0Phase 1;Phase 2United States
984EUCTR2013-004034-15-GB
(EUCTR)
27/01/201529/08/2014 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
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]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
985EUCTR2014-002556-77-SK
(EUCTR)
20/01/201503/11/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
986EUCTR2014-002557-19-SK
(EUCTR)
20/01/201503/11/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
987EUCTR2013-001746-33-FR
(EUCTR)
14/01/201522/06/2015A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
988EUCTR2013-001746-33-BE
(EUCTR)
12/01/201503/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab Doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
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]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
989EUCTR2014-001645-24-CZ
(EUCTR)
09/01/201530/09/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc subsidiary of Valeant Pharmaceuticals International IncNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
990EUCTR2014-001644-38-CZ
(EUCTR)
09/01/201519/09/2014A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc. subsidiary of Valeant Pharmaceuticals International InNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
991EUCTR2014-002557-19-IT
(EUCTR)
03/01/201510/11/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
992EUCTR2014-002556-77-IT
(EUCTR)
03/01/201511/11/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
993JPRN-UMIN000032485
2015/01/0108/05/2018efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's diseaseefficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study Cron's diseaseadalimumab
azathiopurine
Sakura medical center, Toho universityNULLComplete: follow-up complete20years-old70years-oldMale and Female20Not selectedJapan
994NCT02335281
(ClinicalTrials.gov)
January 20157/1/2015Standardized Fecal Microbiota Transplantation for Inflammatory Bowel DiseaseEfficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel DiseaseInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseProcedure: FMT;Drug: MesalazineYanling WeiNULLRecruiting16 Years70 YearsBoth40Phase 2China
995NCT02272868
(ClinicalTrials.gov)
January 201516/10/2014Fecal Microbial Transplant in Pediatric Crohn's DiseaseFecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control StudyCrohn's DiseaseBiological: Fecal Microbial transplant;Drug: Normal Saline;Drug: rifaximin+omeprazole+miralaxSeattle Children's HospitalNULLCompleted12 Years21 YearsAll7Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
996EUCTR2013-002902-29-DE
(EUCTR)
22/12/201408/08/2014Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: Risankizumab 10 mg/ml
INN or Proposed INN: Risankizumab
Product Code: Risankizumab 90 mg/ml
INN or Proposed INN: Risankizumab
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
997EUCTR2013-004034-15-AT
(EUCTR)
11/12/201412/11/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 19.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
998EUCTR2013-004034-15-SK
(EUCTR)
10/12/201413/10/2014 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
999EUCTR2013-002838-20-BE
(EUCTR)
09/12/201415/09/2014The effect of Vitamin D to prevent post-operative relapse of Crohn's DiseaseThe effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT Crohn's Disease
MedDRA version: 19.0;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: D-CURA
Product Name: D-Cura
INN or Proposed INN: Cholecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
142Phase 3Belgium;Netherlands
1000EUCTR2014-001892-30-HU
(EUCTR)
08/12/201418/09/2014Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's diseasePhase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Disease Crohn’s Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;United Kingdom;Russian Federation;France;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1001EUCTR2014-001644-38-FR
(EUCTR)
08/12/201422/06/2015A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
1002EUCTR2014-001295-65-IT
(EUCTR)
01/12/201427/11/2014Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's DiseaseA phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, multi-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 Moderately to severely active Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
TxCellNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Belgium;Austria;Germany;Italy
1003EUCTR2014-001295-65-AT
(EUCTR)
01/12/201419/11/2014Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's DiseaseA phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 Moderately to severely active Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
TxCellNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Belgium;Austria;Germany;Italy
1004NCT02249078
(ClinicalTrials.gov)
December 201423/9/2014A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseA Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: E6011;Drug: PlaceboEisai Inc.NULLWithdrawn18 YearsN/ABoth0Phase 1NULL
1005NCT02327221
(ClinicalTrials.gov)
December 201423/12/2014Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's DiseaseA Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's DiseaseCrohn DiseaseDrug: Ovasave;Drug: PlaceboTxCellNULLTerminated18 Years70 YearsAll32Phase 2Austria;Belgium;France;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1006EUCTR2014-001295-65-BE
(EUCTR)
28/11/201417/11/2014Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's DiseaseA phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and parallel-group study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn's Disease (Crohn's And Treg Study: CATS29) - CATS29 Moderately to severely active Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
TxCellNULLNot RecruitingFemale: yes
Male: yes
117Phase 2Belgium;Austria;Germany;Italy
1007EUCTR2013-001746-33-NL
(EUCTR)
28/11/201422/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands;Germany
1008EUCTR2014-002557-19-CZ
(EUCTR)
27/11/201430/09/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
1009EUCTR2014-002556-77-CZ
(EUCTR)
27/11/201430/09/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
1010EUCTR2013-004034-15-ES
(EUCTR)
25/11/201422/09/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 17.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1011EUCTR2014-001295-65-DE
(EUCTR)
25/11/201419/11/2014Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's DiseaseA phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 Moderately to severely active Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
TxCellNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Belgium;Austria;Germany;Italy
1012EUCTR2014-001892-30-BE
(EUCTR)
24/11/201418/09/2014Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's diseasePhase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Disease Crohn’s Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Russian Federation;Germany;United Kingdom
1013EUCTR2014-001644-38-HU
(EUCTR)
18/11/201417/09/2014 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany
1014EUCTR2014-001645-24-FR
(EUCTR)
18/11/201422/06/2015A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN
Salix Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
1015EUCTR2014-001645-24-HU
(EUCTR)
18/11/201424/09/2014 A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease Treatment of active Crohn’s disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Salix Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
660Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1016EUCTR2014-002556-77-HU
(EUCTR)
18/11/201409/10/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
1017EUCTR2014-002557-19-HU
(EUCTR)
18/11/201409/10/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
1018EUCTR2014-000261-51-FR
(EUCTR)
04/11/201428/08/2015Randomized, controlled, double bind study, comparing curcumin to placebo, associated with thiopurines, in the the prevention of post-operative Crohn's desease relapsePOPCUR : a randomized, controlled, double bind study, comparing curcuma to placebo, associated with thiopurines, in the prevention of post-operative Crohn's disease recurrence - POPCUR Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Curcuma
Other descriptive name: CURCUMA LONGA RHIZOMA
CHU de Clermont-FerrandNULLNot RecruitingFemale: yes
Male: yes
122Phase 3France
1019NCT02426567
(ClinicalTrials.gov)
November 201417/4/2015The Impact of Crohn's Disease-TReatment-with-EATing Diet and Exclusive Enteral Nutrition on Healthy Gut BacteriaAn Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic ActivityCrohn's Disease;Dietary ModificationOther: Exclusive Enteral Nutrition (EEN);Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)University of GlasgowNULLCompleted18 YearsN/ABoth28N/AUnited Kingdom
1020EUCTR2013-004497-10-RO
(EUCTR)
31/10/201402/06/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1021EUCTR2013-001746-33-DK
(EUCTR)
23/10/201415/05/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
1022EUCTR2013-001746-33-DE
(EUCTR)
08/10/201401/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses forInduction and Maintenance Therapy in Subjects with Moderately toSeverely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
1023EUCTR2013-004034-15-HU
(EUCTR)
07/10/201425/08/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 18.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
1024EUCTR2014-003141-10-BE
(EUCTR)
29/09/201426/09/2014Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie.Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie. Crohn's disease or colitis ulcerosa
MedDRA version: 17.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: UrsoFalk® 250 mg tabletten.
Product Name: UrsoFalk
INN or Proposed INN: ursodeoxycholic acid
Other descriptive name: URSODEOXYCHOLIC ACID
Ghent University HospitalNULLNot RecruitingFemale: yes
Male: yes
80Phase 4Belgium
1025EUCTR2013-004497-10-GB
(EUCTR)
16/09/201423/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celltrion, Inc.NULLNot Recruiting Female: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1026EUCTR2013-004497-10-DK
(EUCTR)
11/09/201402/06/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
1027EUCTR2013-001746-33-IT
(EUCTR)
09/09/201410/04/2014A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 16.1;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
1028JPRN-UMIN000015770
2014/09/0101/12/2014Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease.Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. Crohn's disease (180 <= CDAI < 450)CDAI: Crohn's disease Activity IndexStandard therapy for Crohn's disease (Pentasa 3 g/day)
Patients take curcumin or placebo
Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease ResearchNULLComplete: follow-up complete20years-old70years-oldMale and Female30Not selectedJapan
1029NCT02332356
(ClinicalTrials.gov)
September 20144/1/2015Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's DiseaseTherapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's DiseaseCrohn DiseaseDrug: azathioprine or adalimumab and infliximabTokyo Medical and Dental UniversityNULLRecruiting16 Years65 YearsAll100Phase 3Japan
1030EUCTR2013-005629-21-HU
(EUCTR)
14/08/201411/06/2014Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s diseaseDiagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease Crohn’s disease
MedDRA version: 17.0;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: Remicade
Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab
INN or Proposed INN: INFLIXIMAB
First Department of Medicine, University of SzegedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1031NCT02185014
(ClinicalTrials.gov)
August 12, 20147/7/2014Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: AdalimumabAbbVieNULLCompleted18 Years75 YearsAll252Phase 3Austria;Belgium;Canada;Czech Republic;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;United States
1032EUCTR2013-003199-11-FR
(EUCTR)
12/08/201426/03/2018CURE Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY - CURE Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: ADALIMUMAB
Product Name: HUMIRA
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4France;Belgium
1033EUCTR2014-002056-40-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
1034EUCTR2014-002311-41-FR
(EUCTR)
12/08/201422/06/2015A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPAREA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300France;United Kingdom;Sweden
1035EUCTR2013-004497-10-NL
(EUCTR)
06/08/201403/06/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1036EUCTR2013-004497-10-IT
(EUCTR)
01/08/201427/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
1037JPRN-UMIN000014006
2014/08/0131/07/2014Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease Crohn's diseasedose escalation of infliximabIBD Center, Sapporo Kosei General HospitalNULLRecruiting18years-oldNot applicableMale and Female20Not selectedJapan
1038NCT02000362
(ClinicalTrials.gov)
August 20147/11/2013Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's DiseaseCrohn's DiseaseBiological: Stem cellsKang Stem Biotech Co., Ltd.NULLRecruiting19 Years70 YearsAll24Phase 1;Phase 2Korea, Republic of
1039EUCTR2013-004497-10-ES
(EUCTR)
25/07/201427/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
1040EUCTR2013-004497-10-BE
(EUCTR)
16/07/201412/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1041EUCTR2013-001746-33-CZ
(EUCTR)
10/07/201415/05/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 19.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Netherlands
1042EUCTR2013-004497-10-HU
(EUCTR)
02/07/201422/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
1043NCT02199561
(ClinicalTrials.gov)
July 201422/7/2014Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's DiseaseA Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's DiseaseCrohn's DiseaseBiological: Fecal Microbiota TransplantUniversity of AlbertaNULLCompleted18 Years65 YearsBoth3Phase 1;Phase 2Canada
1044EUCTR2013-005013-13-PL
(EUCTR)
25/06/201431/03/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
1045EUCTR2013-001746-33-ES
(EUCTR)
23/06/201425/04/2014A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1046EUCTR2013-001746-33-HU
(EUCTR)
18/06/201423/04/2014A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 18.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands
1047EUCTR2013-001746-33-SK
(EUCTR)
10/06/201415/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
1048EUCTR2013-001746-33-AT
(EUCTR)
05/06/201415/05/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
1049NCT02179372
(ClinicalTrials.gov)
June 201429/6/2014Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel DiseasesModulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel DiseasesUlcerative Colitis;Crohn's DiseaseDietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo)Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola MalpighiNULLCompleted18 Years80 YearsBoth60N/AItaly
1050NCT02164877
(ClinicalTrials.gov)
June 201413/6/2014Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's DiseaseA Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's DiseaseCrohn's DiseaseDrug: pectinJinling Hospital, ChinaNULLTerminated17 Years40 YearsAll3Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1051NCT02148185
(ClinicalTrials.gov)
May 201420/5/2014Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's DiseaseA Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: MT-1303Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years65 YearsBoth1Phase 1Japan
1052NCT01881464
(ClinicalTrials.gov)
May 201411/6/2013Anti TNF a Improves Endothelial Dysfunction in IBD PatientsAnti TNF a Improves Endothelial Dysfunction in IBD PatientsCrohn's DiseaseDevice: Endopath from Itamar medical - FDA approved device.;Drug: Anti TNF Alfa.Carmel Medical CenterNULLRecruiting18 Years40 YearsBoth20Israel
1053EUCTR2013-005013-13-BG
(EUCTR)
28/04/201423/04/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Phase 3Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
1054EUCTR2012-004222-25-SK
(EUCTR)
28/04/201409/01/2014Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseA 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease Crohn's disease
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]
AB ScienceNULLNot Recruiting Female: yes
Male: yes
450Phase 3France;Czech Republic;Morocco;Slovakia;Greece;Belgium;Spain;Tunisia;India
1055EUCTR2013-004781-34-ES
(EUCTR)
16/04/201425/02/2014Rapidity of response to adalimumab treatment in patients with Crohn´s Disease.Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study. Crohn's disease
MedDRA version: 16.1;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: ADALIMUMAB
INN or Proposed INN: ADALIMUMAB
AbbVie Farmacéutica S.L.U.NULLNot RecruitingFemale: yes
Male: yes
98Phase 4Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1056NCT02065570
(ClinicalTrials.gov)
April 9, 201417/2/2014Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's DiseaseA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationCrohn's DiseaseDrug: AdalimumabAbbVieNULLCompleted18 Years75 YearsAll514Phase 3United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic
1057EUCTR2013-005013-13-LT
(EUCTR)
08/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
1058EUCTR2013-005013-13-CZ
(EUCTR)
03/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
1059EUCTR2013-002857-32-PL
(EUCTR)
02/04/201403/02/2014A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal UlcerationDouble-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
180France;Hungary;Czech Republic;Belgium;Poland;Romania;Russian Federation;Germany;United Kingdom
1060EUCTR2013-001029-17-NL
(EUCTR)
01/04/201417/05/2013Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentrationEfficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX Crohn's disease
MedDRA version: 16.0;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: Remicade
Product Name: Infliximab
Academic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1061JPRN-UMIN000013369
2014/04/0120/03/2014Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's disease Crohn's diseaseOral antibiotics will be administrated on the day before surgery (500mg of kanamycin and 500mg of metronidazole at 14:00, 15:00, and 21:00)
without oral antibiotics
Hyogo college of medicineNULLComplete: follow-up complete20years-old70years-oldMale and Female240Phase 2Japan
1062NCT02913508
(ClinicalTrials.gov)
April 201422/9/2016Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's DiseaseA Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Vedolizumab intravenous injection;Drug: Vedolizumab subcutaneous injectionTakedaNULLWithdrawn18 Years80 YearsBoth0Phase 2NULL
1063ChiCTR-DDT-14004402
2014-03-282014-03-09The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fastingThe study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fasting Obscure gastrointestinal bleeding, iron deficiency anemia , Suspected Crohn’s disease, Suspected small bowel tumors, Surveillance of polyposis syndromes, malabsorption? Celiac disease, nonsteroidal aGroup A:20%Mannitol, 0.9% saline;Group B:20%Mannitol, 0.9% saline?simethicone;Group C:20%Mannitol, 0.9% saline?simethicone;Sanming First Affiliated Hospital of Fujian Medical UniversityNULLCompleted1085BothGroup A:60;Group B:60;Group C:60;4 (Phase 4 study)China
1064EUCTR2013-002857-32-GB
(EUCTR)
18/03/201405/11/2013A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal UlcerationDouble-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom
1065EUCTR2011-000722-30-SE
(EUCTR)
17/03/201413/02/2014A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1066NCT02039063
(ClinicalTrials.gov)
March 14, 20149/1/2014A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's DiseaseA Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseDrug: E6011 2 mg/kg;Drug: E6011 5 mg/kg;Drug: E6011 10 mg/kg;Drug: E6011 15 mg/kgEA Pharma Co., Ltd.NULLCompleted20 Years64 YearsAll28Phase 1;Phase 2Japan
1067EUCTR2013-002651-15-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
1068NCT02088944
(ClinicalTrials.gov)
March 201413/3/2014a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's DiseaseSerological C Reactive Protein or Erythrocyte Sedimentation RateDrug: InfliximabNanfang Hospital of Southern Medical UniversityNULLNot yet recruiting18 Years75 YearsBoth142N/ANULL
1069EUCTR2013-002857-32-DE
(EUCTR)
20/02/201430/10/2013A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal UlcerationDouble-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom
1070NCT02060318
(ClinicalTrials.gov)
February 11, 201410/2/2014Regulatory T-cells and Crohn's DiseaseThe Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cellsCrohn DiseaseDrug: InfliximabHvidovre University HospitalNULLCompleted18 YearsN/AAll47N/ADenmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1071EUCTR2013-002857-32-BE
(EUCTR)
03/02/201407/11/2013A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal UlcerationDouble-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
180France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom
1072JPRN-UMIN000012790
2014/02/0101/02/2014Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease Crohn's diseasedose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 monthsSaitama Medical centerNULLComplete: follow-up complete20years-old65years-oldMale and Female20Not selectedJapan
1073NCT01932658
(ClinicalTrials.gov)
February 201428/6/2013Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease TreatmentAutologous Hematopoietic Stem Cell Transplantation for Crohn's Disease TreatmentCrohn's DiseaseBiological: Hematopoietic stem cell transplantationUniversity of California, Los AngelesNULLWithdrawn7 Years70 YearsBoth0Phase 0United States
1074NCT02048618
(ClinicalTrials.gov)
February 201427/1/2014Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's DiseaseDouble-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal UlcerationCrohn's DiseaseDrug: GLPG0634;Drug: PlaceboGalapagos NVNULLCompleted18 Years75 YearsBoth175Phase 2Belgium;Czech Republic;France;Germany;Hungary;Poland;Romania;Russian Federation;United Kingdom
1075JPRN-JapicCTI-142402
28/1/201427/12/2013Phase III study of MLN0002 (300 mg) in treatment of Crohn's diseasePhase III, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe Crohn's disease Crohn's diseaseIntervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab (300 mg) administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Vedolizumab Placebo administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Takeda Pharmaceutical Company LimitedNULLcomplete1580BOTH157Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1076NCT02038920
(ClinicalTrials.gov)
January 28, 201415/1/2014Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's DiseasePhase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's DiseaseCrohn's DiseaseDrug: Vedolizumab;Drug: Vedolizumab placeboTakedaNULLCompleted15 Years80 YearsAll157Phase 3Japan
1077EUCTR2013-002857-32-CZ
(EUCTR)
21/01/201404/11/2013A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal UlcerationDouble-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom
1078EUCTR2013-002857-32-HU
(EUCTR)
16/01/201404/11/2013A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal UlcerationDouble-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
180France;Czech Republic;Hungary;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom
1079EUCTR2013-002902-29-BE
(EUCTR)
09/01/201420/09/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
1080EUCTR2013-002902-29-ES
(EUCTR)
09/01/201405/12/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1081NCT02227602
(ClinicalTrials.gov)
January 20144/6/2014Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel DiseaseThe Mango Consumption Improves Biomarkers for Inflammation in Inflammatory Bowel Disease PatientsIntestinal Diseases;Ulcerative Colitis;Crohn DiseaseDrug: Mango polyphenolicsTexas A&M UniversityNULLCompleted18 Years72 YearsAll20N/AUnited States
1082NCT02056418
(ClinicalTrials.gov)
January 201424/1/2014Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in AdultA Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in AdultCrohn DiseaseDietary Supplement: enteral nutrition;Drug: corticosteroidJinling Hospital, ChinaNULLActive, not recruiting18 Years75 YearsBoth30Phase 4China
1083NCT02615288
(ClinicalTrials.gov)
January 201423/11/2015High Dose Vitamin D3 in Crohn's DiseaseImpact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled StudyCrohn's DiseaseDietary Supplement: Vitamin D3McMaster UniversityCanadian Association of GastroenterologyCompleted18 Years70 YearsBoth40N/ANULL
1084NCT02044952
(ClinicalTrials.gov)
January 201419/1/2014Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction RemissionProspective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction RemissionInflammatory Bowel Diseases;Crohn's Disease;Gastrointestinal Diseases;Digestive System Diseases;Intestinal DiseasesDrug: Mesalazine, Tripterygium glycosidesZhu WeimingNULLRecruiting18 Years75 YearsBoth40Phase 2;Phase 3China
1085NCT02349594
(ClinicalTrials.gov)
January 201416/1/2015Immune Modulation by Parenteral Fish Oil in Patients With Crohn's DiseaseModulation of Immune Function by Parenteral Fish Oil in Patients With Crohn's Disease and High Inherent Tumor Necrosis Factor-alpha Production: a Randomized, Single Blinded, Cross-over StudyCrohn DiseaseDrug: Omegaven 10%;Drug: Intralipid 20%Radboud UniversityNULLCompleted18 Years70 YearsBoth6Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1086EUCTR2012-005226-29-PT
(EUCTR)
20/12/201324/09/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
INN or Proposed INN: azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: metronidazole
Product Name: metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: Metronidazole
Centro Hospitalar de São João E.P.E.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Portugal;Canada;Poland;Belgium;Israel;Netherlands
1087EUCTR2011-001332-29-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
1088NCT02015793
(ClinicalTrials.gov)
December 201313/12/2013Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's DiseaseA Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive ProteinCrohn's DiseaseBiological: Adalimumab;Biological: Placebo for adalimumabAbbVieNULLCompleted18 Years70 YearsAll30Phase 2China
1089EUCTR2010-023034-23-SE
(EUCTR)
29/11/201301/11/2013A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1090EUCTR2012-004222-25-BE
(EUCTR)
26/11/201314/01/2013Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseA 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease Crohn's disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
AB ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Central African Republic;Slovakia;Greece;Spain;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Netherlands;Tunisia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1091EUCTR2011-000722-30-AT
(EUCTR)
19/11/201315/10/2013A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
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]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden
1092EUCTR2013-002838-20-NL
(EUCTR)
12/11/201306/09/2013The effect of Vitamin D to prevent post-operative relapse of Crohn's DiseaseThe effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT Crohn's Disease
MedDRA version: 18.0;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: InVita D3
INN or Proposed INN: Colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
142Phase 3Belgium;Netherlands
1093EUCTR2011-003622-27-NL
(EUCTR)
30/10/201319/02/2013A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
1094EUCTR2010-023034-23-AT
(EUCTR)
10/10/201320/08/2013A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1095EUCTR2012-001723-12-ES
(EUCTR)
07/10/201314/08/2013adalimumab intralesional in intestinal strictures of Crohn's disease patientsA randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients Crohn disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Fundació Clínic per a la Recerca BiomèdicaNULLNot RecruitingFemale: yes
Male: yes
102Phase 3Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1096NCT02859675
(ClinicalTrials.gov)
October 7, 201328/7/2016Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's DiseaseOlfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's DiseaseCrohn's Disease;Olfactogustatory PerceptionOther: triangular test;Biological: blood sampling;Other: QuestionnairesCentre Hospitalier Universitaire DijonNULLRecruiting18 Years60 YearsFemale75France
1097EUCTR2012-000645-13-BE
(EUCTR)
09/09/201316/07/2013Infliximab as firsdt treatment instead of second line treatment in Crohns diseaseInfliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: RemicadeErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Belgium;Netherlands
1098JPRN-JapicCTI-142426
01/9/2013A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's DiseaseA Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease Crohn's DiseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 80mg every other week
Control intervention name : null
AbbVie GKNULL15BOTH28Phase 3NULL
1099NCT01958827
(ClinicalTrials.gov)
September 20134/10/2013A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's DiseaseA Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseBiological: AdalimumabAbbVieNULLCompleted15 YearsN/AAll28Phase 3Japan
1100NCT01951326
(ClinicalTrials.gov)
September 201319/9/2013Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's DiseaseA Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: RHB-104;Drug: PlaceboRedHill Biopharma LimitedNULLCompleted18 Years75 YearsAll331Phase 3United States;Australia;Bulgaria;Canada;Czechia;Israel;New Zealand;Poland;Serbia;Slovakia;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1101EUCTR2011-001754-28-HR
(EUCTR)
22/08/201328/08/2014A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1102EUCTR2013-002932-25-NL
(EUCTR)
21/08/201325/07/2013A randomized clinical trial: treatment of perianal fistulas in Crohn's diseaseMultimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Academic Medical CenterNULLNot Recruiting Female: yes
Male: yes
126Phase 4Netherlands
1103EUCTR2011-003622-27-HR
(EUCTR)
20/08/201328/08/2014A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1104EUCTR2011-001733-16-HR
(EUCTR)
19/08/201328/08/2014A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1105EUCTR2013-000971-34-DK
(EUCTR)
01/08/201301/08/2013High dose vitamin D treatment in Crohn's disease affects the gut immune cellsMucosal immune regulation by high dose vitamin D treatment in Crohn’s disease - MirViDiC Active Crohn's Disease in colon and/or terminal ileum
MedDRA version: 19.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Jørgen AgnholtNULLNot Recruiting Female: yes
Male: yes
50Phase 3Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1106NCT01523106
(ClinicalTrials.gov)
August 201318/1/2012L-carnitine to Treat Fatigue Associated With Crohn's DiseaseL-carnitine to Treat Fatigue Associated With Crohn's DiseaseCrohn's Disease;FatigueDrug: L-carnitine;Other: PlaceboUniversity of California, San FranciscoNULLWithdrawn18 Years70 YearsBoth0N/AUnited States
1107EUCTR2013-001212-30-NL
(EUCTR)
04/07/201318/06/2013Immune modulation by parenteral Fish oil in patients with Crohn’s diseaseModulation of immune function by parenteral fish oil in patients with Crohn’s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Omegaven
Trade Name: Intralipid 10%
NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
1108ChiCTR-DDT-14004999
2013-07-012014-07-17Endoscopic Ultrasonography (EUS) Helps Differentiate Crohn's Disease from Intestinal TuberculosisEndoscopic Ultrasonography (EUS) Helps Differentiate Crohn's Disease from Intestinal Tuberculosis Crohn's disease and intestinal tuberculosisGold Standard:;Index test:;West China Hospital, Sichuan UniversityNULLCompleted1641BothTarget condition:0;Difficult condition:0China
1109NCT01915927
(ClinicalTrials.gov)
July 201331/7/2013Stem Cell Fistula Plug in Perianal Crohn's DiseaseA Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.Perianal Crohn's DiseaseDrug: MSC-AFPWilliam A. Faubion, M.D.NULLCompleted18 Years65 YearsAll20Phase 1United States
1110NCT02887287
(ClinicalTrials.gov)
July 201329/8/2016Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's DiseaseEfficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical TreatmentDrug: EENSun Yat-sen UniversityNULLCompleted18 Years60 YearsBoth48N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1111EUCTR2010-022383-12-BG
(EUCTR)
13/06/201320/05/2013A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden
1112EUCTR2010-022384-35-BG
(EUCTR)
13/06/201328/05/2013A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1113EUCTR2011-003622-27-AT
(EUCTR)
04/06/201318/03/2013A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1114EUCTR2011-002817-12-BG
(EUCTR)
03/06/201320/05/2013A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand
1115EUCTR2013-001503-37-DK
(EUCTR)
31/05/201306/05/2013Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel DiseaseEffect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease)
MedDRA version: 14.1;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: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Allopurinol
INN or Proposed INN: allopurinol
Other descriptive name: ALLOPURINOL SODIUM
Marianne Kiszka-KanowitzNULLNot RecruitingFemale: yes
Male: yes
46Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1116NCT01827631
(ClinicalTrials.gov)
May 27, 20135/4/2013Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese SubjectsSingle and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese SubjectsCrohn's DiseaseDrug: GSK1605786 capsuleGlaxoSmithKlineNULLCompleted18 Years45 YearsAll21Phase 1China
1117NCT02233062
(ClinicalTrials.gov)
May 20131/9/2014Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's DiseaseImpact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's DiseaseCrohn's DiseaseDietary Supplement: Exclusive Enteral Nutrition TherapyJinling Hospital, ChinaNULLCompleted18 Years40 YearsMale12N/AChina
1118NCT02073526
(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
1119EUCTR2012-005226-29-BE
(EUCTR)
26/04/201314/03/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole
Wolfson Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Portugal;United States;Canada;Poland;Belgium;Israel;Netherlands
1120EUCTR2012-002432-93-BG
(EUCTR)
24/04/201305/03/2013A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s diseaseA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease Crohn's disease
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]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
114Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria;United States;Serbia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1121EUCTR2011-002817-12-NL
(EUCTR)
19/04/201307/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Germany;Norway;Japan;New Zealand;Sweden
1122EUCTR2012-004098-26-DE
(EUCTR)
17/04/201303/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy
1123EUCTR2012-004098-26-FR
(EUCTR)
10/04/201325/09/2015Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2aUnited States;France;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy
1124NCT02676622
(ClinicalTrials.gov)
April 201321/4/2013Autologous Stem Cell Transplant for Refractory Crohn's DiseaseA Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's DiseaseCrohn's DiseaseDrug: mobilization of stem cells to prepare for Leukapheresis;Other: Leukapheresis- Collection of stem cells;Drug: Preparative regimen 4-6 weeks after Leukapheresis;Other: Stem Cell Transplant;Drug: Low-dose IL-2 administrationNationwide Children's HospitalNULLWithdrawn12 Years29 YearsAll0Phase 2NULL
1125JPRN-UMIN000010524
2013/03/2917/04/2013Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy Crohn's diseaseAdalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards.
Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician.
Tokyo Medical & Dental University GastroenterologyNULLComplete: follow-up complete15years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1126NCT01804166
(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
1127EUCTR2011-002640-27-DE
(EUCTR)
08/03/201323/08/2012A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis)A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY ACTIVE CROHN'S DISEASE
MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0301
Product Code: 40 mg
INN or Proposed INN: NA
Other descriptive name: GED-0301
Product Name: GED-0301
Product Code: 10 mg
INN or Proposed INN: NA
Other descriptive name: GED-0301
GIULIANINULLNot RecruitingFemale: yes
Male: yes
160Phase 2Germany;Italy
1128NCT01769755
(ClinicalTrials.gov)
March 201315/1/2013A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's DiseaseCrohns DiseaseBiological: PDA001;Drug: Vehicle Controlled PlaceboCelularity IncorporatedNULLCompleted18 Years75 YearsAll14Phase 1United States
1129NCT01828190
(ClinicalTrials.gov)
March 20138/4/2013The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha BlockersProspective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha BlockersCrohn's Disease;Perianal FistulasOther: Hyperbaric oxygenAssaf-Harofeh Medical CenterNULLRecruiting18 Years70 YearsBoth50N/AIsrael
1130NCT01809275
(ClinicalTrials.gov)
March 20138/3/2013Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's DiseaseA Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's DiseaseCrohn's Disease;Inflammatory Bowel DiseaseDrug: QBECO;Drug: PlaceboQu Biologics Inc.NULLCompleted18 YearsN/ABoth68Phase 1;Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1131NCT01810185
(ClinicalTrials.gov)
March 201311/3/2013Low Dose Naltrexone in Symptomatic Inflammatory Bowel DiseaseLow Dose Naltrexone in Symptomatic Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisDrug: Low dose naltrexone;Drug: PlaceboSanta Barbara Cottage HospitalNULLWithdrawn18 YearsN/ABoth0Phase 2United States
1132NCT01826188
(ClinicalTrials.gov)
March 201328/3/2013Combined THC and CBD Drops for Treatment of Crohn's DiseaseCombined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled TrialCrohn's DiseaseDrug: THC 5mg/ml and CBS 50mg/ml;Drug: PlaceboMeir Medical CenterNULLCompleted20 Years85 YearsAll50Phase 1;Phase 2Israel
1133EUCTR2012-004098-26-IT
(EUCTR)
25/02/201311/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active,moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 inSubjects with Moderate to Severe Crohn's Disease Who Have Failed or AreIntolerant to Anti-tumor Necrosis Factor-alpha Therapy - MEDI 2070 Crohn's Disease
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]
Product Name: MEDI2070
Product Code: MEDI2070
Other descriptive name: anticorpo monoclonale anti IL-23
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
120Phase 2Spain;Germany;Italy;France;United States;Hungary;Czech Republic;Canada
1134EUCTR2012-002867-86-DK
(EUCTR)
13/02/201312/02/2013Prevention of serious pneumococcal infections in people with Crohn's diseasePneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease - PneuVac Crohn's Disease
MedDRA version: 15.1;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Pnemovax
Product Name: Pneumovax
Trade Name: Prevenar 13
Product Name: Prevenar 13
Statens Serum InstitutNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
1135EUCTR2012-004098-26-HU
(EUCTR)
11/02/201311/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
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]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Czech Republic;Hungary;Canada;Spain;Poland;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1136EUCTR2012-004098-26-CZ
(EUCTR)
08/02/201307/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn's Disease
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]
Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy
1137EUCTR2012-002432-93-PL
(EUCTR)
06/02/201309/01/2013A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s diseaseA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
114United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Bulgaria
1138EUCTR2011-002817-12-DE
(EUCTR)
05/02/201306/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
1139NCT01714726
(ClinicalTrials.gov)
February 1, 201324/10/2012Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha TherapyCrohn's DiseaseDrug: MEDI2070;Drug: placeboAllerganNULLCompleted18 Years65 YearsAll121Phase 2United States;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;Czech Republic
1140NCT01802593
(ClinicalTrials.gov)
February 201324/12/2012Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine FailurePhase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator FailureCrohn's DiseaseDrug: AZATHIOPRINE or METHOTREXATEProf. Arie LevineNULLTerminated6 Years18 YearsBoth20Phase 4Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1141NCT01751152
(ClinicalTrials.gov)
February 201313/12/2012A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's DiseaseA Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's DiseaseInflammation;Crohn's DiseaseDrug: NNC0114-0006;Drug: placeboNovo Nordisk A/SNULLCompleted18 Years75 YearsAll53Phase 2United States;Bulgaria;Czech Republic;Poland;Slovakia;Spain;Russian Federation;Serbia
1142NCT01765998
(ClinicalTrials.gov)
February 20136/1/2013The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of InflammationCrohn's DiseaseDrug: Probiotic;Drug: PlaceboThe Baruch Padeh Medical Center, PoriyaNULLNot yet recruiting18 Years60 YearsBoth60Phase 4Israel
1143NCT01874015
(ClinicalTrials.gov)
February 20136/6/2013Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's DiseaseTransplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's DiseaseCrohn's DiseaseBiological: mesenchymal cell transplantation;Biological: mesenchymal cell and fibroblast injectionRoyan InstituteNULLRecruiting18 Years65 YearsAll10Phase 1Iran, Islamic Republic of
1144NCT02010762
(ClinicalTrials.gov)
February 201310/12/2013The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's DiseaseThe Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized TrialCrohn's DiseaseDrug: Vitamin D;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)NULLCompleted18 YearsN/AAll142Phase 4Netherlands
1145EUCTR2012-002432-93-SK
(EUCTR)
29/01/201328/03/2013A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s diseaseA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease Crohns disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
114United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1146EUCTR2012-004098-26-ES
(EUCTR)
28/01/201322/01/2013Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn´s disease.A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn´s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy Crohn´s Disease
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]
Product Name: MEDI2070
INN or Proposed INN: Not available
Other descriptive name: Anti-IL-23 monoclonal antibody
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Germany;Italy
1147EUCTR2012-002432-93-CZ
(EUCTR)
18/01/201305/09/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s diseaseA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease Crohns disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
114Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria
1148EUCTR2011-002817-12-CZ
(EUCTR)
09/01/201308/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseRandomizované, dvojite zaslepené klinické hodnocení aktivní lécby pro navození klinické odpovedi a/nebo remise pri podávání GSK1605786A pacientum se stredne težkou až težkou aktivní Crohnovou chorobou. Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand
1149EUCTR2012-002030-37-BE
(EUCTR)
08/01/201305/09/2012A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOTA DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT Crohn’s Disease (CD) and Ulcerative Colitis (UC)
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]
Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
1150EUCTR2012-000529-31-NL
(EUCTR)
07/01/201322/01/2013A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1151JPRN-UMIN000009596
2013/01/0121/12/2012Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). Crohn`s diseaseWithdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Department of Internal Medicine, School of Medicine, Keio UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female200Not selectedJapan
1152NCT02501291
(ClinicalTrials.gov)
January 201320/5/2015Thalidomide in Treating Crohn's DiseaseThalidomide in Inducing and Maintaining Remission of Crohn's DiseaseCrohn's DiseaseDrug: ThalidomideFirst Affiliated Hospital, Sun Yat-Sen UniversityNULLCompleted18 Years75 YearsBoth47Phase 2China
1153EUCTR2011-000722-30-IT
(EUCTR)
30/12/201219/12/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: PF-04236921
INN or Proposed INN: PF-04236921
Other descriptive name: IMP will be labeled as PF-04236921 106mg/vial, Clonal SC lyophilized form
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
180United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Australia;Denmark;New Zealand;Sweden
1154EUCTR2011-002817-12-DK
(EUCTR)
19/12/201230/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden
1155EUCTR2012-000529-31-DE
(EUCTR)
17/12/201201/10/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1156EUCTR2011-002817-12-HU
(EUCTR)
13/12/201206/11/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1157NCT01696396
(ClinicalTrials.gov)
December 4, 201227/9/2012Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: Abrilumab;Drug: PlaceboAmgenNULLCompleted18 Years65 YearsAll254Phase 2United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Netherlands;Switzerland;United Kingdom;Czech Republic
1158NCT01078935
(ClinicalTrials.gov)
December 20121/3/2010The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of InflammationThe Effect of Probiotics on Bowel DiseaseCrohn's Disease;Ulcerative ColitisDietary Supplement: probiotics;Dietary Supplement: placeboThe Baruch Padeh Medical Center, PoriyaMinistry of Health, IsraelNot yet recruiting18 Years80 YearsBoth100Phase 4NULL
1159NCT01752790
(ClinicalTrials.gov)
December 201212/12/2012Efficacy and Safety of Top-down Therapy in Pediatric Crohn's DiseaseEfficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label TrialPediatric Crohn's DiseaseDrug: Top-down;Drug: Step-upUniversity of Roma La SapienzaNULLWithdrawn6 Years18 YearsBoth0Phase 4Italy
1160NCT01820247
(ClinicalTrials.gov)
December 201225/3/2013Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction RemissionEfficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction RemissionCrohn's DiseaseDrug: enteral nutrition;Drug: Tripterygium glycosidesZhu WeimingNULLRecruiting18 Years75 YearsBoth100N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1161NCT01349920
(ClinicalTrials.gov)
November 28, 20125/5/2011Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)Crohn DiseaseDrug: InfliximabMerck Sharp & Dohme Corp.NULLCompleted18 Years60 YearsAll15Moldova, Republic of;United Kingdom
1162JPRN-UMIN000009284
2012/11/2020/11/2012The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease PatientsThe Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients - The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection)adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week.Sakura Medical Center,Toho universityNULLComplete: follow-up complete18years-old65years-oldMale and Female20Phase 2Japan
1163EUCTR2012-002432-93-ES
(EUCTR)
16/11/201202/10/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s diseaseA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s disease Crohns disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
114United States;Serbia;Hungary;Czech Republic;Slovakia;Poland;Spain;Bulgaria;Russian Federation
1164EUCTR2011-001754-28-NL
(EUCTR)
15/11/201227/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib (CP-690,550)
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1165EUCTR2011-001733-16-NL
(EUCTR)
15/11/201222/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib (CP-690,550)
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1166EUCTR2012-000529-31-HU
(EUCTR)
13/11/201204/10/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 16.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2France;United States;Czech Republic;Hungary;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
1167EUCTR2010-023034-23-CZ
(EUCTR)
12/11/201226/06/2012A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Romania;Australia;Denmark;Germany;New Zealand;Sweden
1168EUCTR2011-001733-16-CZ
(EUCTR)
12/11/201222/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1169EUCTR2011-003622-27-CZ
(EUCTR)
12/11/201203/04/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1170EUCTR2011-001754-28-CZ
(EUCTR)
12/11/201215/02/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1171EUCTR2011-000722-30-CZ
(EUCTR)
12/11/201221/03/2012A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden
1172EUCTR2012-000529-31-BE
(EUCTR)
09/11/201219/09/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
1173EUCTR2012-002432-93-HU
(EUCTR)
08/11/201225/09/2012A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s diseaseA randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease Crohns disease
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]
Product Code: 0114-0006B
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
114United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Bulgaria
1174NCT01817426
(ClinicalTrials.gov)
November 201229/8/2012Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete RemissionDiscontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled StudyCrohn DiseaseDrug: Infliximab;Other: PlaceboCopenhagen University Hospital at HerlevNULLRecruiting18 YearsN/ABoth136Phase 4Denmark
1175EUCTR2012-000529-31-CZ
(EUCTR)
18/10/201221/09/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1176EUCTR2012-000645-13-NL
(EUCTR)
17/10/201212/07/2012Infliximab as first treatment instead of second line treatment in Crohns diseaseInfliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: RemicadeErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Belgium;Netherlands;Italy
1177EUCTR2012-000529-31-DK
(EUCTR)
10/10/201226/09/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Austria;Denmark;Netherlands;Germany;United Kingdom
1178EUCTR2012-000529-31-AT
(EUCTR)
09/10/201203/10/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
1179EUCTR2011-006084-22-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
1180EUCTR2011-004763-72-NL
(EUCTR)
04/10/201230/05/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
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]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BUnited States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1181NCT01823042
(ClinicalTrials.gov)
October 201225/3/2013The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).Crohn's DiseaseDrug: azathioprine+enteral nutrition;Drug: AzathioprineJinling Hospital, ChinaNULLRecruiting18 Years75 YearsBoth100N/AChina
1182NCT01596894
(ClinicalTrials.gov)
October 201212/4/2012Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's DiseaseA Randomized, Single Blinded, Controlled, Multi Center Phase 4 Study for Induction of Remission in Active Pediatric Crohn's Disease, Using 2 Months Antibiotic Course of Azithromycin Combined With Metronidazole vs. Metronidazole Alone.Crohn's DiseaseDrug: Azithromycin + Metronidazole;Drug: MetronidazoleProf. Arie LevineNULLCompleted5 Years17 YearsAll73Phase 4Israel
1183NCT01692808
(ClinicalTrials.gov)
October 201217/9/2012Bioavailability of Vitamin D in Children and Adolescents With Crohn's DiseaseBioavailability of Vitamin D in Children and Adolescents With Crohn's Disease.Crohn's DiseaseDrug: Vitamin D3 3000 UI daily;Drug: Vitamin D3 4000 UI dailySt. Justine's HospitalNULLCompleted10 Years18 YearsBoth20Phase 2Canada
1184EUCTR2012-000529-31-GB
(EUCTR)
27/09/201221/09/2012A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease Moderate to severe Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Amgen IncNULLNot Recruiting Female: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
1185EUCTR2011-006064-43-DE
(EUCTR)
27/09/201217/02/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. Perianal fistulising Crohn´s disease
MedDRA version: 17.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix S.A.U.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1186EUCTR2010-024638-48-BG
(EUCTR)
26/09/201203/10/2012A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;United States;Serbia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
1187EUCTR2012-002702-51-DK
(EUCTR)
24/09/201201/08/2012Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled studyDiscontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
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: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
Department of medical gastroenterology S, Odense University HospitalNULLNot RecruitingFemale: yes
Male: yes
136Phase 4Finland;Denmark;Norway;Sweden
1188JPRN-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
1189EUCTR2010-023437-30-BG
(EUCTR)
18/09/201217/07/2012Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1190EUCTR2011-004763-72-GB
(EUCTR)
13/09/201225/06/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01+ UK-specific Amendment 04 (dated 23-Apr-12) Crohn’s Disease
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]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BUnited States;Taiwan;Hong Kong;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1191EUCTR2011-006064-43-IT
(EUCTR)
13/09/201205/03/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's diseaseA phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks. ADMIRE-CD study. - ADIMIRE-CD study Perianal fistulising Crohn's disease
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601
Product Code: Cx601
INN or Proposed INN: NA
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs)
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy
1192NCT01632462
(ClinicalTrials.gov)
September 201225/6/2012A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's DiseaseA Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's DiseaseCrohn's DiseaseDrug: VSL#3Federico II UniversityNULLRecruiting5 Years17 YearsBoth30Phase 4Italy
1193EUCTR2011-003622-27-DE
(EUCTR)
20/08/201230/03/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE - Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Netherlands Antilles;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1194EUCTR2011-000854-44-LV
(EUCTR)
10/08/201219/06/2012A clinical study for treatment of Crohns Disease with the new drug substance TRK-170. The study consists of two parts and are conducted at servral hopsitals in Europe. Patients in the study may receive placebo (drug with no effect) but either the doctor or the patient will know during the study.A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn’s Disease Crohn's disease
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]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
510Czech Republic;Hungary;Poland;Bulgaria;Norway;Latvia;Sweden
1195NCT03079700
(ClinicalTrials.gov)
August 1, 20129/3/2017Immune Modulation From Trichuris SuisMucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected IndividualCrohn Disease;Ulcerative Colitis;Intestinal HelminthiasisBiological: Trichuris suis eggsUniversity of AarhusNULLCompleted18 Years70 YearsMale1N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1196EUCTR2011-005886-19-DK
(EUCTR)
31/07/201231/07/2012Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST)Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) - CONTRAST Crohns Disease with active disease
MedDRA version: 14.1;Level: PT;Classification code 10059696;Term: Scan with contrast;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10028049;Term: MRI;Classification code 10045434;Term: Ultrasound scan;System Organ Class: 10022891 - Investigations;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: SonoVue
INN or Proposed INN: sulphur hexafluoride
Other descriptive name: SULFUR HEXAFLUORIDE
Gastroenterology MIDTNULLNot RecruitingFemale: yes
Male: yes
Denmark
1197EUCTR2011-005846-36-DK
(EUCTR)
31/07/201231/07/2012Bloodflow measurements in stenotic inflammatory bowel disease.Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS) - STENOSIS Crohns Disease undergoing elective surgery for intestinal stenosis.
MedDRA version: 14.1;Level: PT;Classification code 10058829;Term: Elective surgery;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1;Classification code 10059696;Term: Scan with contrast;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10028049;Term: MRI;Classification code 10045434;Term: Ultrasound scan;Classification code 10022699;Term: Intestinal stenosis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: SonoVue
INN or Proposed INN: sulphur hexafluoride
Other descriptive name: SULFUR HEXAFLUORIDE
Gastroenterology MIDTNULLNot RecruitingFemale: yes
Male: yes
Denmark
1198EUCTR2011-002517-11-BG
(EUCTR)
18/07/201227/06/2012The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placeboA multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab Moderate to severe Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
96Phase 2France;Serbia;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany
1199EUCTR2011-004763-72-IT
(EUCTR)
16/07/201203/09/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12) Crohn’s Disease
MedDRA version: 15.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
Other descriptive name: anti-IL-6 mAb
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BUnited States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;India;Czech Republic;Hungary;European Union;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
1200EUCTR2011-004763-72-CZ
(EUCTR)
11/07/201221/05/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
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]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BHong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1201EUCTR2011-003622-27-BG
(EUCTR)
11/07/201219/05/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1202EUCTR2010-022382-10-AT
(EUCTR)
10/07/201224/04/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden
1203EUCTR2011-004763-72-DE
(EUCTR)
04/07/201227/04/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12);Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
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]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BUnited States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
1204EUCTR2011-006064-43-NL
(EUCTR)
03/07/201205/07/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease.A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study Perianal fistulising Crohn´s disease
MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A. UnipersonalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy
1205NCT01576471
(ClinicalTrials.gov)
July 201210/4/2012Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to PlaceboA Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseBiological: Trichuris suis ova (TSO);Biological: PlaceboCoronado Biosciences, Inc.NULLCompleted18 Years65 YearsAll250Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1206NCT00692939
(ClinicalTrials.gov)
June 26, 20123/6/2008Autologous Stem Cell Transplantation for Crohn's DiseaseAutologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's DiseaseCrohn's DiseaseBiological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: MesnaPaul SzabolcsNULLRecruiting10 Years60 YearsAll20Phase 1;Phase 2United States
1207EUCTR2011-004763-72-HU
(EUCTR)
26/06/201226/04/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
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]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BUnited States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
1208EUCTR2011-006064-43-BE
(EUCTR)
22/06/201221/02/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study. Perianal fistulising Crohn´s desease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: N/A
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A. UnipersonalNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy
1209EUCTR2011-003038-14-NL
(EUCTR)
21/06/201231/05/2012A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASEA RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX Luminal active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Netherlands
1210EUCTR2010-022382-10-ES
(EUCTR)
20/06/201211/05/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn's Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn's Disease Subjects with Moderately-to-Severely Active Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Hungary;Germany;Netherlands;France;Norway;Italy;Austria;South Africa;Sweden;Australia;Israel;Czech Republic;Slovakia;United Kingdom;New Zealand;Canada;Denmark;Belgium;Korea, Republic of;Spain;Japan;United States;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1211EUCTR2011-004820-37-ES
(EUCTR)
13/06/201215/02/2012Experimental study in humans to evaluate the efficacy and safety of bloodproducts rich in proteins for the treatment of anal fistulas in Crohn'spatientsPhase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;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: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Other descriptive name: HUMAN PLASMA FOR FRACTIONATION
Fundación FISEVINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
1212EUCTR2012-000729-28-ES
(EUCTR)
13/06/201217/04/2012Imaging study in patients with Crohn`s DiseaseMULTICENTER STUDY IN PATIENTS WITH CROHN?S DISEASE FOR CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY ASSAYS FOR ASSESSMENT OF DISEASE ACTIVITY Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease
MedDRA version: 14.1;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Product Name: /
Product Code: /
INN or Proposed INN: ÁCIDO GADOBÉNICO
Other descriptive name: NA
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Belgium;France;Spain;United States
1213EUCTR2009-017998-37-BE
(EUCTR)
08/06/201211/04/2012Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Ghent University HospitalNULLNot Recruiting Female: yes
Male: yes
36Phase 3Belgium
1214EUCTR2011-003622-27-SE
(EUCTR)
07/06/201209/02/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
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]
Product Code: CP-690,550-10Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden
1215EUCTR2010-023437-30-PL
(EUCTR)
06/06/201208/05/2012Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1216EUCTR2011-006127-38-ES
(EUCTR)
05/06/201215/02/2012Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment.Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot in processed with PRGF-system technology, in the treatment of anal fistulas in Crohn's patients with no concomitant therapy with second-line drugs. Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Other descriptive name: HUMAN PLASMA FOR FRACTIONATION
Fundación FISEVINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
1217EUCTR2011-003622-27-GR
(EUCTR)
05/06/201224/05/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
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]
Product Code: CP-690,550-10Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden
1218EUCTR2011-001754-28-DE
(EUCTR)
05/06/201217/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1219EUCTR2010-024638-48-PL
(EUCTR)
04/06/201209/05/2012A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United StatesNULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
1220JPRN-UMIN000008199
2012/06/0119/06/2012The investigations for improving successful judgment rate with PillCam Patency Capsule and differential diagnosis in Crohn's disease patients with following capsule endoscopy. Crohn's disease, Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin more than 3 monthsPatients administered with mosapride
Patients administered with no mosapride
Department of Gastroenterology, Graduate School of Medicine, Osaka City UniversityNULLComplete: follow-up complete12years-old85years-oldMale and Female40Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1221JPRN-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
1222EUCTR2011-000854-44-BG
(EUCTR)
01/06/201207/05/2012A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat several hospitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TRK-170
Product Code: TRK-170
INN or Proposed INN: Not available
Product Name: TRK-170
Product Code: TRK-170
INN or Proposed INN: Not available
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
510Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden
1223NCT01181765
(ClinicalTrials.gov)
June 201212/8/2010The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera EndoscopyThe Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study)Crohn's DiseaseBiological: Infliximab 5 mg/kg body weight infused over 2 hoursJanssen Inc.NULLCompleted18 YearsN/ABoth1Phase 4Canada
1224NCT01624376
(ClinicalTrials.gov)
June 201214/6/2012Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105.Fistulizing Crohn's DiseaseDrug: DLX105;Drug: PlaceboDelenex Therapeutics AGNULLCompleted18 Years65 YearsBoth18Phase 2Switzerland
1225NCT01545050
(ClinicalTrials.gov)
June 20121/3/2012Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Placebo matching with BMS-945429;Biological: BMS-945429CSL BehringNULLTerminated18 YearsN/AAll72Phase 2United States;Austria;Canada;Czechia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Switzerland;Taiwan;United Kingdom;Australia;Brazil;Czech Republic;Russian Federation;Singapore
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1226NCT01635621
(ClinicalTrials.gov)
June 20123/7/2012A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's DiseaseA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Olokizumab Administered Subcutaneously to Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: Olokizumab (OKZ);Drug: PlaceboUCB BIOSCIENCES GmbHNULLWithdrawn18 Years65 YearsBoth0Phase 2Bulgaria;Czech Republic;Germany;Hungary;Poland
1227NCT01442025
(ClinicalTrials.gov)
June 201220/9/2011Study Investigating Tailored Treatment With Infliximab for Active Crohn's DiseaseA Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's DiseaseCrohn's DiseaseDrug: InfliximabGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth121Phase 4France
1228EUCTR2011-001733-16-BG
(EUCTR)
29/05/201230/03/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1229EUCTR2011-001754-28-BG
(EUCTR)
29/05/201207/05/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1230EUCTR2011-004763-72-AT
(EUCTR)
25/05/201227/04/2012Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s DiseaseA Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 Crohn’s Disease
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]
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
350Phase 2BUnited States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1231EUCTR2010-022382-10-SK
(EUCTR)
22/05/201212/04/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden
1232EUCTR2010-022384-35-SK
(EUCTR)
16/05/201213/04/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1233EUCTR2011-006064-43-AT
(EUCTR)
15/05/201205/03/2012Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. Perianal fistulising Crohn´s disease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
1234EUCTR2011-003622-27-HU
(EUCTR)
10/05/201221/03/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Ukraine;United States;Greece;Spain;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1235JPRN-UMIN000009631
2012/05/0226/12/2012Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled study Crohn's diseaseIn the intervention group, sivelestat sodium will be continuously administered intravenously at 4.8 mg/kg from introduction of anesthesia until a maximum of 2 days after surgery.
In the control group, sivelestat sodium will not be administered and conventional treatment will be given.
Department of Surgery 2,Tokyo Women's Medical UniversityNULLRecruiting16years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1236JPRN-UMIN000008043
2012/05/0128/05/2012The influence of medication for Crohn's disease on serological response to the influenza vaccinationThe influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination Crohn's diseaseInfluenza Vaccination to Crohn's disease patients treated with Infliximab

Influenza Vaccination to Crohn's disease patients treated with Elemental diet
Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)
The Jikei University School of MedicineDivision of Gastroenterology and HepatologyNULLComplete: follow-up complete16years-old60years-oldMale and Female150Phase 4Japan
1237NCT01387594
(ClinicalTrials.gov)
May 201230/6/2011Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFsA Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative ColitisProcedure: lumbar puncture;Drug: lumbar punctureShireNULLCompleted18 Years75 YearsAll49Phase 1Austria;Belgium;France;Germany;Netherlands
1238EUCTR2011-002517-11-CZ
(EUCTR)
23/04/201225/01/2012The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placeboA multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab Moderate to severe Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
96Serbia;Hungary;Czech Republic;Germany
1239EUCTR2011-002817-12-SK
(EUCTR)
19/04/201213/04/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Germany;France;Hong Kong;Austria;Sweden;South Africa;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Hungary;Switzerland;Netherlands;Chile;Norway;Italy;Israel;United Kingdom;Russian Federation;Slovakia;Ukraine;Taiwan;Denmark;Argentina;Estonia;China;Spain;Japan
1240EUCTR2011-003622-27-ES
(EUCTR)
17/04/201216/02/2012A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASEA OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASE Crohn's Disease
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]
Product Code: CP-690,550-10Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1241EUCTR2010-022758-18-BE
(EUCTR)
16/04/201207/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
1242EUCTR2010-022760-12-BE
(EUCTR)
16/04/201207/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1243EUCTR2011-000722-30-GB
(EUCTR)
12/04/201206/05/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
160Phase 2United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1244EUCTR2010-023589-39-DE
(EUCTR)
10/04/201216/05/2011A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ST10-021
Product Code: ST10-021
Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)
Iron Therapeutics (Switzerland) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
1245EUCTR2011-001733-16-DE
(EUCTR)
10/04/201218/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017, USANULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1246EUCTR2011-000854-44-CZ
(EUCTR)
04/04/201212/01/2012A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease Crohn's disease
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]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
510Hungary;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden
1247EUCTR2010-022760-12-NL
(EUCTR)
04/04/201213/07/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1310Phase 3Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1248EUCTR2011-001754-28-GR
(EUCTR)
02/04/201216/02/2012A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1249NCT01877577
(ClinicalTrials.gov)
April 201211/6/2013Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis DSupplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.Crohn's Disease (CD);Ulcerative Colitis (UC)Dietary Supplement: Vitamin D3University of California, San FranciscoNULLCompleted18 YearsN/ABoth30N/AUnited States
1250NCT01470599
(ClinicalTrials.gov)
April 201227/10/2011A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's DiseaseA Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's DiseaseCrohn's DiseaseDrug: CP-690,550PfizerNULLCompleted18 Years76 YearsAll150Phase 2United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1251EUCTR2011-003038-14-BE
(EUCTR)
30/03/201203/01/2012A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASEA RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX Luminal active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Belgium;Netherlands
1252EUCTR2011-002817-12-PT
(EUCTR)
29/03/201218/01/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1253EUCTR2010-022383-12-PT
(EUCTR)
29/03/201218/01/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1254EUCTR2010-022384-35-PT
(EUCTR)
29/03/201218/01/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1255EUCTR2010-022382-10-IT
(EUCTR)
28/03/201202/03/2012A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to-Severely Active Crohn's Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to Severely Active Crohn's Disease Subjects with Moderately-to-Severely Active Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;South Africa;Norway;Germany;Netherlands;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1256EUCTR2010-022383-12-IT
(EUCTR)
28/03/201202/03/2012A 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Japan;Sweden
1257EUCTR2010-022384-35-IT
(EUCTR)
28/03/201202/03/2012A 25 month study of a potential new medicine (GSK1605786A) for thetreatment of Crohn's diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A inSubjects with Crohn's Disease - Open label extension study Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand;Japan;Sweden
1258EUCTR2011-002817-12-ES
(EUCTR)
27/03/201211/01/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's Disease Moderately-to-Severely Active Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1259EUCTR2010-022384-35-ES
(EUCTR)
27/03/201211/01/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn's diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn's Disease - Open label extension study Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1260EUCTR2010-022383-12-ES
(EUCTR)
27/03/201211/01/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1261EUCTR2011-002517-11-HU
(EUCTR)
26/03/201209/01/2012The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placeboA multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab Moderate to severe Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
96Serbia;Czech Republic;Hungary;Germany
1262EUCTR2011-002981-19-PL
(EUCTR)
21/03/201212/01/2012Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease.Revised Protocol 043 incorporating Protocol Amendment 05Pharmacogenetics Blood Sample Amendment 01 CROHN’S DISEASE
MedDRA version: 16.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.1;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2aUnited States;France;Hungary;Belgium;Poland;South Africa
1263EUCTR2010-024638-48-BE
(EUCTR)
19/03/201225/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
1264EUCTR2010-022384-35-AT
(EUCTR)
13/03/201227/12/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;New Zealand;Sweden
1265EUCTR2010-023034-23-BE
(EUCTR)
12/03/201205/09/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1266EUCTR2011-000722-30-BE
(EUCTR)
12/03/201205/09/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
160United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden
1267EUCTR2011-005966-39-BE
(EUCTR)
08/03/201212/12/2011Therapeutic effect of mesenchymal cells in patients suffering from a disease characterized by a severe inflammation and/or in whom the immune system attacks their own tissues.Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders. Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.0;Level: PT;Classification code 10064147;Term: Gastrointestinal inflammation;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: mesenchymal stem cells
Product Code: MSC
CHU-ULgNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Belgium
1268EUCTR2010-022383-12-SK
(EUCTR)
07/03/201212/04/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden
1269EUCTR2011-002981-19-HU
(EUCTR)
06/03/201227/12/2011Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 CROHN’S DISEASE
MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2aFrance;United States;Hungary;Belgium;Poland;South Africa
1270EUCTR2010-022384-35-EE
(EUCTR)
01/03/201206/02/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1271EUCTR2010-022383-12-EE
(EUCTR)
01/03/201206/02/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1272EUCTR2011-002817-12-EE
(EUCTR)
01/03/201206/02/2012A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900Greece;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand
1273NCT01540292
(ClinicalTrials.gov)
March 201222/2/2012Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune DisordersMesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune DisordersCrohn's DiseaseBiological: Mesenchymal Stem Cells (MSC)University Hospital of LiegeNULLRecruiting18 Years75 YearsBoth20Phase 1;Phase 2Belgium
1274NCT02450513
(ClinicalTrials.gov)
March 201212/5/2015Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic StudyAdalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic StudyCrohn's DiseaseDrug: AdalimumabUniversitaire Ziekenhuizen LeuvenNULLRecruiting18 Years65 YearsBoth30N/ABelgium
1275NCT01580670
(ClinicalTrials.gov)
March 20123/4/2012Clinical Study of TA-650 in Pediatric Patients With Crohn's DiseaseClinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's DiseasePediatric Crohn's DiseaseDrug: TA-650Mitsubishi Tanabe Pharma CorporationNULLCompleted6 Years17 YearsAll14Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1276NCT01393899
(ClinicalTrials.gov)
March 201212/7/2011The Safety And Efficacy Of Maintenance Therapy With CP-690,550A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: CP-690,550PfizerNULLCompleted18 Years75 YearsAll180Phase 2United States;Australia;Austria;Bulgaria;Canada;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;India
1277NCT01647412
(ClinicalTrials.gov)
March 201219/7/2012Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's DiseaseGrowth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical TrialCrohn's DiseaseDrug: Growth Hormone;Dietary Supplement: Nutraceutical Combination;Other: Exclusion Diet;Other: Placebo Growth HormoneColumbia UniversityNULLWithdrawn10 Years17 YearsBoth0Phase 2United States
1278EUCTR2010-024638-48-DE
(EUCTR)
22/02/201230/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
1279EUCTR2011-002517-11-DE
(EUCTR)
22/02/201202/11/2011The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placeboA multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab Moderate to severe Crohn’s disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 15.0;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
96Serbia;Czech Republic;Hungary;Germany
1280EUCTR2010-022384-35-PL
(EUCTR)
15/02/201211/01/2012A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1281EUCTR2010-022383-12-PL
(EUCTR)
15/02/201211/01/2012A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
1282EUCTR2011-002981-19-BE
(EUCTR)
14/02/201214/12/2011Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 CROHN’S DISEASE
MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2aFrance;United States;Hungary;Poland;Belgium;South Africa
1283EUCTR2011-001754-28-ES
(EUCTR)
02/02/201207/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn?s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1284JPRN-UMIN000007343
2012/02/0121/02/2012The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patientsThe study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients Crohn's diseasePatients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody).
Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.
Tohoku University Graduate School of Medicine (Tohoku University Hospital)NULLComplete: follow-up complete20years-oldNot applicableMale and Female90Not applicableJapan
1285NCT02399683
(ClinicalTrials.gov)
February 201212/3/2015Immune Modulation From Trichuris TrichiuraMucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected IndividualCrohn Disease;Colitis, Ulcerative;Intestinal HelminthiasisBiological: Trichuris trichiura eggsUniversity of AarhusNULLCompleted18 Years70 YearsMale1N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1286NCT01514240
(ClinicalTrials.gov)
February 201210/1/2012Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in JapanA Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in JapanCrohn's DiseaseDrug: D9421-C capsule 3 mg;Drug: Mesalazine tabletsAstraZenecaNULLCompleted15 Years130 YearsAll123Phase 3Japan
1287EUCTR2010-024638-48-NO
(EUCTR)
31/01/201201/06/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Serbia;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden
1288EUCTR2011-001754-28-AT
(EUCTR)
26/01/201221/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1289EUCTR2010-022383-12-AT
(EUCTR)
26/01/201229/12/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;Denmark;Australia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden
1290EUCTR2011-002817-12-AT
(EUCTR)
26/01/201228/12/2011A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1291EUCTR2011-001733-16-AT
(EUCTR)
26/01/201221/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1292EUCTR2011-001733-16-HU
(EUCTR)
24/01/201214/11/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Norway;Germany;Japan;Korea, Republic of;Sweden
1293EUCTR2011-005678-47-IT
(EUCTR)
19/01/201221/12/2011A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission.A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. - IGON 2 CROHN'S DISEASE IN REMISSION PHASE
MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0301
Product Code: NA
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
1294EUCTR2010-020137-10-HU
(EUCTR)
12/01/201222/11/2011Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 16.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden
1295EUCTR2011-001754-28-HU
(EUCTR)
10/01/201217/11/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib
Product Code: CP-690,550-10
Other descriptive name: Tofacitinib
Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1296EUCTR2011-003966-34-ES
(EUCTR)
10/01/201213/10/2011Biomarkers in diagnosis & treatment of patients with Crohn?s disease treated with immunosuppressantsThe ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn?s disease treated with immunosuppressants - not applicable Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)NULLNot RecruitingFemale: yes
Male: yes
180Spain
1297EUCTR2010-022384-35-GR
(EUCTR)
09/01/201227/12/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1298EUCTR2010-022383-12-GR
(EUCTR)
09/01/201214/12/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Hong Kong;Taiwan;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1299EUCTR2011-001733-16-GR
(EUCTR)
09/01/201214/12/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1300EUCTR2011-002817-12-GR
(EUCTR)
09/01/201214/12/2011A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
900United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1301JPRN-UMIN000006889
2012/01/0101/01/2012Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy Crohn's diseaseRepeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion.
Repeat 3 infusions of the 10mg/kg/dose infliximab in 8 weeks interval.
Department of Lower Gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete16years-old75years-oldMale and Female50Phase 4Japan
1302JPRN-UMIN000007514
2012/01/0115/03/2012Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence Crohn's diseaseAdalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
Nagoya University Gradeate School of MedicineDepartment of GastroenterologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female25Phase 2Japan
1303EUCTR2011-000885-36-ES
(EUCTR)
26/12/201129/11/2011Adalimub treatment to prevent recurrency post-surgery in Crohn disease.Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment - APPRECIA Compare efficay of Adalimub vs Azatioprina to prevent surgical intervention in Chron disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Other descriptive name: Adalimumab
Trade Name: Imurel
Product Name: Imurel
INN or Proposed INN: Azatioprina
Other descriptive name: Imurel
Trade Name: Flagyl
Product Name: Flagyl
INN or Proposed INN: Metronidazol
Other descriptive name: Flagyl
GETECCUNULLNot RecruitingFemale: yes
Male: yes
Spain
1304EUCTR2011-001733-16-ES
(EUCTR)
23/12/201128/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn?s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1305EUCTR2010-022759-42-IS
(EUCTR)
22/12/201129/10/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Iceland;New Zealand;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1306EUCTR2011-000722-30-HU
(EUCTR)
14/12/201121/10/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden
1307EUCTR2010-022760-12-BG
(EUCTR)
14/12/201111/11/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1310Phase 3Brazil;Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1308EUCTR2011-001754-28-SE
(EUCTR)
14/12/201119/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Australia;South Africa;Croatia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1309EUCTR2008-005237-30-SE
(EUCTR)
14/12/201116/08/2011A Multicenter, Prospective, Long-term Registry of children with Crohn's DiseaseA Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Janssen Biologics BVNULLNot RecruitingFemale: yes
Male: yes
4000Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Italy;United States;Sweden
1310EUCTR2010-022382-10-HU
(EUCTR)
14/12/201111/10/2011A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1311EUCTR2010-022384-35-HU
(EUCTR)
14/12/201111/10/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
1312EUCTR2010-022383-12-HU
(EUCTR)
14/12/201111/10/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
1313EUCTR2011-003966-34-BE
(EUCTR)
06/12/201111/10/2011Biomarkers in diagnosis & treatment of patients with Crohn’s disease treated with immunosuppressants The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn’s disease treated with immunosuppressants Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Spain;Belgium
1314EUCTR2010-022759-42-BG
(EUCTR)
02/12/201111/11/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
1315EUCTR2011-003743-22-IT
(EUCTR)
01/12/201108/03/2012A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease
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: Entocort
INN or Proposed INN: BUDESONIDE
ASTRAZENECANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United States;Canada;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1316EUCTR2010-022759-42-NL
(EUCTR)
01/12/201113/07/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
1317EUCTR2010-023437-30-NO
(EUCTR)
01/12/201101/06/2011Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Portugal;Germany;Netherlands;Norway;France;Austria;South Africa;Sweden;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
1318NCT01466374
(ClinicalTrials.gov)
December 20113/11/2011Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: BMS-936557 (Anti-IP-10 Antibody)Bristol-Myers SquibbNULLCompleted18 YearsN/ABoth121Phase 2United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa
1319NCT01991314
(ClinicalTrials.gov)
December 201118/11/2013Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous SulphateTreatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and FatigueUlcerative Colitis;Crohn's DiseaseDrug: Ferrous sulphateQueen Mary University of LondonNULLCompleted13 Years80 YearsAll90Phase 4United Kingdom
1320NCT01453946
(ClinicalTrials.gov)
December 201114/10/2011Safety and Maintenance Study of Entocort for Children With Crohn's DiseaseA Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveCrohn's DiseaseDrug: EntocortPerrigo CompanyNULLCompleted5 Years17 YearsAll55Phase 3United States;Canada;Germany;Italy;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1321EUCTR2010-023034-23-DE
(EUCTR)
21/11/201114/07/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden
1322EUCTR2011-001733-16-SE
(EUCTR)
17/11/201119/10/2011A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10Pfizer Inc.235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
275United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
1323EUCTR2010-023437-30-DE
(EUCTR)
16/11/201126/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
1324EUCTR2010-024638-48-NL
(EUCTR)
11/11/201108/06/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Canada;Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden;Korea, Republic of
1325EUCTR2010-023437-30-NL
(EUCTR)
11/11/201108/06/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's DiseaseA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Crohn's Disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1326NCT01536418
(ClinicalTrials.gov)
November 11, 201116/2/2012An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's DiseaseA Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786AGlaxoSmithKlineNULLTerminated18 YearsN/AAll255Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;China;Czech Republic;Ireland;South Africa
1327EUCTR2011-000854-44-PL
(EUCTR)
09/11/201112/08/2011A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
510Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Sweden
1328EUCTR2011-000722-30-IE
(EUCTR)
02/11/201113/05/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden
1329JPRN-UMIN000007047
2011/11/0110/01/2012Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's diseaseEffect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease - Effect of adacolumn and adalimumab combination therapy for Crohn's disease Crohn's diseaseAdacolumn and adalimumab combination therapy for 10 weeks.
Adalimumab single therapy for remain 94 weeks.
Adacolumn single therapy for 104 weeks.
Yamaguchi University Graduate School of Medicine Department of Gastroenterology and HepatologyNULLComplete: follow-up complete12years-old75years-oldMale and Female40Not applicableJapan
1330NCT01442363
(ClinicalTrials.gov)
November 201126/9/2011A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's DiseasePerianal Crohn's DiseaseDrug: BLI-1300 low dose;Drug: BLI-1300 high dose;Drug: placeboBraintree LaboratoriesNULLTerminated18 YearsN/ABoth8Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1331NCT01218360
(ClinicalTrials.gov)
November 20117/10/2010Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)Crohn DiseaseDrug: Physician standard-of-careMerck Sharp & Dohme Corp.NULLCompleted18 Years65 YearsBoth71N/AGreece
1332NCT01444092
(ClinicalTrials.gov)
November 201128/9/2011Safety Study of Entocort for Children With Crohn's DiseaseA Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveCrohn's DiseaseDrug: EntocortPerrigo CompanyNULLCompleted5 Years17 YearsAll123Phase 3United States;Canada;Germany;Italy;Poland
1333NCT01540942
(ClinicalTrials.gov)
November 201123/2/2012Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's DiseaseA Randomized, Controlled, Open-label Study to Investigate the Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's DiseaseCrohn's DiseaseDietary Supplement: nutrition treat;Other: surgeryJinling Hospital, ChinaNULLCompleted18 Years75 YearsBoth91N/AChina
1334NCT01434693
(ClinicalTrials.gov)
November 201113/9/2011Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's DiseaseA Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's DiseaseCrohn's DiseaseBiological: Trichuris suis ova;Other: PlaceboCoronado Biosciences, Inc.NULLCompleted18 Years55 YearsAll36Phase 1United States
1335EUCTR2011-000722-30-DK
(EUCTR)
25/10/201117/10/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1336EUCTR2011-000722-30-GR
(EUCTR)
24/10/201119/08/2011A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II Crohn’s disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden
1337EUCTR2010-022758-18-GB
(EUCTR)
21/10/201102/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
1338EUCTR2010-023034-23-IT
(EUCTR)
21/10/201129/12/2011A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERSA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS(ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: PF-04236921
INN or Proposed INN: PF-04236921
Other descriptive name: IMP will be labeled as ''PF-04236921 106mg/vial, Clonal SC lyophilized form''.
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
240United States;Greece;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden
1339EUCTR2010-022760-12-GB
(EUCTR)
21/10/201102/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;New Zealand;Japan
1340EUCTR2010-022759-42-GB
(EUCTR)
21/10/201102/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1341EUCTR2010-022758-18-IE
(EUCTR)
17/10/201108/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 15.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
1342EUCTR2010-022760-12-IE
(EUCTR)
17/10/201108/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1343EUCTR2010-022760-12-FR
(EUCTR)
13/10/201123/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
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]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1275Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand
1344JPRN-UMIN000006232
2011/10/0101/09/2011Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab Crohn's diseasetreatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine)
treatment with only high dose infliximab
Saitama Medical UniversityNULLComplete: follow-up complete15years-old70years-oldMale and Female40Not selectedJapan
1345NCT01433432
(ClinicalTrials.gov)
October 201112/9/2011Open Label Extension Study to Protocol C2/13/DR-6MP-02Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension StudyCrohn's DiseaseDrug: 80 mg DR-6MPTeva GTCNULLWithdrawn18 Years75 YearsBoth0Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1346NCT01393626
(ClinicalTrials.gov)
October 201111/7/2011A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: CP-690,550PfizerNULLCompleted18 Years75 YearsAll280Phase 2United States;Australia;Austria;Bulgaria;Canada;Croatia;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;India;Romania;Sweden
1347EUCTR2010-024638-48-SK
(EUCTR)
29/09/201111/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
1348EUCTR2010-023437-30-SK
(EUCTR)
29/09/201111/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA) - OPERA Crohn's Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Norway;Germany;Korea, Republic of;Sweden
1349EUCTR2010-023034-23-HU
(EUCTR)
20/09/201110/06/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1350NCT01489943
(ClinicalTrials.gov)
September 19, 20111/12/2011A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult SubjectsA Single Centre, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult SubjectsCrohn's DiseaseDrug: GSK1605786 500 mg;Drug: Midazolam 3 mg;Drug: Pioglitazone 15 mg;Drug: Omeprazole 40 mg;Drug: Rosuvastatin 10 mgGlaxoSmithKlineNULLCompleted18 Years55 YearsAll24Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1351EUCTR2010-023034-23-GB
(EUCTR)
15/09/201116/06/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden
1352NCT01369355
(ClinicalTrials.gov)
September 13, 20117/6/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's Disease;Colitis;IBD;Inflammatory Bowel DiseaseDrug: Placebo SC;Drug: Placebo IV;Drug: Ustekinumab 90 mg SC q8w;Drug: Ustekinumab 130 mg IV;Drug: Ustekinumab 90 mg SC q12wJanssen Research & Development, LLCNULLCompleted18 Years99 YearsAll1282Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Czech Republic
1353EUCTR2010-022759-42-ES
(EUCTR)
13/09/201127/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
1354EUCTR2010-022760-12-DE
(EUCTR)
13/09/201126/05/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1355EUCTR2011-000854-44-HU
(EUCTR)
06/09/201102/06/2011A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries, Inc.NULLNot RecruitingFemale: yes
Male: yes
609Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1356EUCTR2010-024638-48-PT
(EUCTR)
02/09/201126/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
1357EUCTR2010-023437-30-PT
(EUCTR)
02/09/201126/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Crohn's Disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 2Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden
1358EUCTR2010-022760-12-ES
(EUCTR)
02/09/201103/11/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn?s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn?s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1275Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand
1359JPRN-UMIN000005689
2011/09/0131/05/2011GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial Crohn's diseasePatients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.
Department of Gastroenterology and Hepatology, Kyoto University HospitalNULLComplete: follow-up complete12years-old75years-oldMale and Female60Not applicableJapan
1360EUCTR2010-022758-18-ES
(EUCTR)
01/09/201122/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3Hungary;Germany;European Union;Ireland;Italy;Austria;South Africa;Australia;Brazil;Israel;Czech Republic;United Kingdom;New Zealand;Serbia;Canada;Iceland;Denmark;Belgium;Korea, Republic of;Spain;Japan;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1361EUCTR2010-023034-23-DK
(EUCTR)
30/08/201111/07/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden
1362EUCTR2010-022759-42-DE
(EUCTR)
29/08/201126/05/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
1363EUCTR2010-022758-18-DE
(EUCTR)
24/08/201126/05/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
1364EUCTR2010-022758-18-CZ
(EUCTR)
22/08/201108/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 16.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
1365EUCTR2010-022760-12-CZ
(EUCTR)
17/08/201108/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1366EUCTR2010-022758-18-DK
(EUCTR)
15/08/201125/07/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
1367EUCTR2010-022760-12-DK
(EUCTR)
15/08/201126/08/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1368EUCTR2010-023797-39-GB
(EUCTR)
12/08/201116/07/2011TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASETREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. 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
Barts Health NHS TrustNULLNot Recruiting Female: yes
Male: yes
90Phase 4United Kingdom
1369EUCTR2010-022760-12-IT
(EUCTR)
09/08/201130/03/2012A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.0;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1310Phase 3Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1370EUCTR2010-022759-42-HU
(EUCTR)
09/08/201110/08/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1371EUCTR2010-022758-18-IT
(EUCTR)
09/08/201122/06/2012Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
JANSSEN-CILAG INTERNATIONAL N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
1372EUCTR2010-022759-42-IT
(EUCTR)
09/08/201123/01/2012A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
JANSSEN-CILAG INTERNATIONAL N.V.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
1373EUCTR2010-022760-12-HU
(EUCTR)
09/08/201108/07/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
1374EUCTR2010-018431-18-CZ
(EUCTR)
08/08/201119/05/2011A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 16.1;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: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
1375EUCTR2011-000854-44-BE
(EUCTR)
04/08/201120/04/2011A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
609Phase 2Latvia;Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1376EUCTR2010-023589-39-GB
(EUCTR)
02/08/201119/05/2011A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Iron Therapeutics (Switzerland) AGNULLNot Recruiting Female: yes
Male: yes
60Phase 3Hungary;Austria;Germany;United Kingdom
1377EUCTR2010-022760-12-IS
(EUCTR)
02/08/201108/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
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]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1275Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand
1378EUCTR2010-022758-18-HU
(EUCTR)
02/08/201110/08/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
1379NCT01352221
(ClinicalTrials.gov)
August 201110/5/2011Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2)Iron Deficiency Anaemia;Inflammatory Bowel Disease;Crohn's DiseaseDrug: ST10;Drug: Placebo oral capsuleShield TherapeuticsNULLCompleted18 YearsN/AAll128Phase 3Austria;United Kingdom
1380EUCTR2010-022760-12-AT
(EUCTR)
28/07/201101/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1381EUCTR2010-022758-18-AT
(EUCTR)
28/07/201101/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
1382EUCTR2011-002821-24-IT
(EUCTR)
21/07/201127/02/2012Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011 Treatment of active, moderate Crohn’s disease
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]
Product Name: Rifaximin-EIR
Product Code: NA
INN or Proposed INN: RIFAXIMIN
Other descriptive name: NA
ALFA WASSERMANNNULLNot RecruitingFemale: yes
Male: yes
Italy
1383EUCTR2010-022215-19-GB
(EUCTR)
21/07/201123/06/2011Combined growth hormone and IGF1 therapy in paediatric Crohn'd diseaseA Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s Impaired growth in Paediatric Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution
Other descriptive name: Recombinant human Insulin-like Growth Factor
Trade Name: NutropinAq®
Product Name: NutropinAq 10mg/2ml solution for injection
INN or Proposed INN: Somatropin(rhGH)
Other descriptive name: recombinant growth hormone
Greater Glasgow & Clyde NHSNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom
1384EUCTR2010-023034-23-GR
(EUCTR)
19/07/201120/06/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 INSUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden
1385EUCTR2011-000854-44-NO
(EUCTR)
19/07/201101/06/2011A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
609Hungary;Czech Republic;Norway;Latvia;Poland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1386EUCTR2010-024638-48-ES
(EUCTR)
15/07/201118/11/2011A7281007; Multi-center open-label extension study for PF-00547659MULTICENTER OPEN-LABEL EXTENSION STUDY FOR PF-00547659(OPERA II) - OPERA II Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: No aplicable
Product Code: PF-00547659
INN or Proposed INN: No aplicable
Other descriptive name: No aplicable
PFIZER, S.L.U.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
1387EUCTR2010-018431-18-HU
(EUCTR)
14/07/201113/05/2011A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 16.1;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: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
1388EUCTR2011-002640-27-IT
(EUCTR)
14/07/201109/02/2012A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis)A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY ACTIVE CROHN'S DISEASE
MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0301
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany;Italy
1389EUCTR2009-016488-12-NL
(EUCTR)
12/07/201126/10/2010A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy
1390EUCTR2010-022758-18-IS
(EUCTR)
08/07/201108/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
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]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3Hungary;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Germany;Iceland;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1391JPRN-UMIN000005970
2011/07/0113/07/2011Investigation on the remission maintaining effect of Polaprezinc in patients with Crohn's disease in remission phase. Patients with Crohn's disease in remission phasePolaprezinc administration group: patients has Polaprezinc 150mg/day for xxx months with Crohn's disease maintenance therapy.
Polaprezinc non administration group: patients treated with Crohn's disease maintenance therapy only.
Kawasaki Medical SchoolNULLRecruiting20years-oldNot applicableMale and Female100Not selectedJapan
1392JPRN-UMIN000005946
2011/07/0107/07/2011Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD Crohn's diseaseEndoscopic balloon dilation using balloon assisted enteroscopy are performed for eligible small bowel stricture of patients with CD.Fukuoka University Chikushi HospitalNULLComplete: follow-up continuing15years-old75years-oldMale and Female100Not selectedJapan
1393NCT01298492
(ClinicalTrials.gov)
July 1, 201126/1/2011A Study To Monitor Long-Term Treatment With PF-00547659A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA IICrohn's DiseaseDrug: PF-00547659ShireNULLCompleted18 Years75 YearsAll268Phase 2United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden
1394NCT01369342
(ClinicalTrials.gov)
July 20117/6/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)Crohn's Disease;Inflammatory Bowel Disease;IBD;ColitisDrug: Group 1: Placebo;Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kgJanssen Research & Development, LLCNULLCompleted18 Years99 YearsAll640Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Croatia;France;Germany;Hungary;Iceland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Ireland
1395NCT01369329
(ClinicalTrials.gov)
July 20117/6/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)Crohn's Disease;IBD;Colitis;Inflammatory Bowel DiseaseDrug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg;Drug: Group 1: PlaceboJanssen Research & Development, LLCNULLCompleted18 YearsN/AAll769Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Serbia;South Africa;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1396EUCTR2010-020836-21-PL
(EUCTR)
29/06/201128/06/2011A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s diseaseA randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease Crohn’s disease
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]
Product Name: NNC0142-0000-0002
Product Code: NNC142-0002
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
100United States;Hungary;European Union;Canada;Belgium;Poland;Israel;Russian Federation
1397EUCTR2011-002061-38-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
1398EUCTR2010-023589-39-AT
(EUCTR)
22/06/201117/05/2011A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ST10-021
Product Code: ST10-021
Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)
Iron Therapeutics (Switzerland) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
1399EUCTR2010-023034-23-IE
(EUCTR)
03/06/201107/04/2011A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
220Phase 2United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
1400EUCTR2010-023437-30-ES
(EUCTR)
03/06/201113/06/2011Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERAEstudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Enfermedad de Crohn Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: PF-00547659
Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: No aplicable
PFIZER SLUNULLNot RecruitingFemale: yes
Male: yes
240Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1401EUCTR2010-024638-48-AT
(EUCTR)
01/06/201125/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
210Phase 2Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
1402EUCTR2010-024638-48-SE
(EUCTR)
01/06/201125/05/2011A7281007; Multi-center open-label extension study for PF-00547659A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II Crohn’s disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
1403EUCTR2010-023437-30-AT
(EUCTR)
01/06/201125/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA Crohn's Disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
1404EUCTR2010-023437-30-SE
(EUCTR)
01/06/201125/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA Crohn's Disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
1405JPRN-UMIN000005251
2011/06/0101/06/2011A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab Crohn's diseaseAdministration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly.Department of Gastroenterology and Hepatology, Tokyo Medical and Dental UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female14Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1406NCT01345318
(ClinicalTrials.gov)
June 201128/4/2011B0151005 Open-Label Extension StudyA Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)Crohn's DiseaseBiological: PF-04236921PfizerNULLCompletedN/AN/AAll191Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;New Zealand;Switzerland;United Kingdom
1407NCT01355614
(ClinicalTrials.gov)
June 201116/5/2011A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsA Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's DiseaseCrohn's DiseaseDrug: QAX576;Drug: InfliximabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll10Phase 2Germany;Switzerland
1408EUCTR2010-022384-35-BE
(EUCTR)
30/05/201107/12/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1409EUCTR2010-022383-12-BE
(EUCTR)
30/05/201107/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
1410EUCTR2010-023437-30-BE
(EUCTR)
27/05/201125/05/2011Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsA DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA Crohn's Disease
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]
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1411EUCTR2010-020881-53-ES
(EUCTR)
25/05/201101/12/2010Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease.Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease. Crohn's disease / Enfermedad de Crohn
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
195Netherlands;Belgium;Spain
1412EUCTR2010-022384-35-CZ
(EUCTR)
13/05/201131/03/2011An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s DiseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - SHIELD 3 Subjects with Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
1413EUCTR2010-022383-12-CZ
(EUCTR)
12/05/201130/03/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease - SHIELD 2 Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden
1414NCT01316939
(ClinicalTrials.gov)
May 9, 20113/3/2011GSK1605786A in the Maintenance of Remission in Subjects With Crohn's DiseaseA 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786A;Drug: PlaceboGlaxoSmithKlineNULLTerminated18 YearsN/AAll229Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland
1415EUCTR2010-022384-35-DK
(EUCTR)
06/05/201101/04/2011A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1416EUCTR2011-000854-44-SE
(EUCTR)
02/05/201101/03/2011A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
609Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia
1417ChiCTR-TRC-11001321
2011-05-012011-05-01Effect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's DiseaseEffect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's Disease Crohn's disease;ICD:K50.9control group:Total parenteral nutrition (TPN) will be administrated to patients from day1 to day7 after the operation. Non-protein energy of the TPN is 120kJ/kg/d, of which 60% is supplied by glucose and 40% by fat emulsion. Amino acid of the TPN is 0.8-1.0g/kg/d. Electrolyte, vitamins, trace elements will be added into the TPN. Glucose/insulin ratio is 5:1. In this group, medium-long chain triglyceride will be used.;?-3 Fat group:Total parenteral nutrition (TPN) will be administrated to patients from day1 to day7 after the operation. Non-protein energy of the TPN is 120kJ/kg/d, of which 60% is supplied by glucose and 40% by fat emulsion. Amino acid of the TPN is 0.8-1.0g/kg/d. Electrolyte, vitamins, trace elements will be added into the TPN. Glucose-insulin ratio is 5:1. In this group, medium-long chain triglyceride and ?-3 fish oil fat (Omegaven);The First Affiliated Hospital of Sun Yat-sen UniversityNULLCompleted1475Bothcontrol group:30;?-3 Fat group:30;China
1418NCT01346826
(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
1419EUCTR2010-019996-32-BG
(EUCTR)
27/04/201124/02/2011A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 Moderate to severe Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
1420EUCTR2010-022383-12-DK
(EUCTR)
08/04/201102/03/2011A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1421NCT01276509
(ClinicalTrials.gov)
April 6, 201112/1/2011Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's DiseaseA Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)Crohn's DiseaseDrug: PF-00547659 SC injectionShireNULLCompleted18 Years75 YearsAll265Phase 2United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden
1422EUCTR2009-016488-12-DE
(EUCTR)
04/04/201112/11/2010Study of Vedolizumab in Patients With Moderate to Severe Crohn's DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3United States;Slovakia;Turkey;Austria;Israel;Italy;France;Hungary;Czech Republic;Canada;Malaysia;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand;Korea, Republic of
1423EUCTR2010-020881-53-NL
(EUCTR)
04/04/201117/12/2010A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s DiseaseA Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease Crohns Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
195Netherlands;Belgium;Spain
1424NCT01318993
(ClinicalTrials.gov)
April 1, 20113/3/2011Open-Label Extension Study of GSK1605786AAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786AGlaxoSmithKlineNULLTerminated18 YearsN/AAll399Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;New Zealand;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland
1425NCT02504255
(ClinicalTrials.gov)
April 201120/7/2015Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's DiseaseEvaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter CohortCrohn DiseaseBiological: Biological samplings;Other: QuestionnairesHospices Civils de LyonNULLCompleted18 YearsN/ABoth144France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1426NCT01345799
(ClinicalTrials.gov)
April 201128/4/2011A Study of TRK-170 for the Treatment of Crohn's DiseaseA Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's DiseaseCrohn's DiseaseDrug: TRK-170;Drug: PlaceboToray Industries, IncNULLCompleted18 Years50 YearsBoth123Phase 2Belgium;Bulgaria;Czech Republic;France;Hungary;Latvia;Netherlands;Norway;Poland;Romania;Serbia;Sweden;Ukraine
1427NCT01341808
(ClinicalTrials.gov)
April 201125/4/2011Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) PatientsImmunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis ABiological: Epaxal Berna (virosomal hepatitis A vaccine)Asan Medical CenterNULLCompleted18 Years40 YearsBoth493Phase 4Korea, Republic of
1428EUCTR2010-019996-32-DE
(EUCTR)
31/03/201122/11/2010A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
1429EUCTR2009-016488-12-IT
(EUCTR)
23/03/201118/05/2011A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease - NDA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease - ND moderate to Severe Crhon`s Disease
MedDRA version: 13.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Monoclonal antibodies
MILLENNIUM PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy
1430EUCTR2010-020137-10-BE
(EUCTR)
23/03/201104/10/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1431EUCTR2010-022384-35-GB
(EUCTR)
22/03/201130/12/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
800Phase 3United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1432EUCTR2010-019996-32-HU
(EUCTR)
18/03/201131/01/2011A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 12.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2Hungary;Belgium;Bulgaria;Netherlands;Germany
1433EUCTR2010-023347-14-BE
(EUCTR)
02/03/201104/01/2011Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LARAn open pilot studyTreatment of Crohn’s disease-associated refractory diarrhoea with octreotide LARAn open pilot study Crohn Disease refractory diarrhoea
MedDRA version: 12.1;Level: LLT;Classification code 10066533;Term: Diarrhea recurrent
Trade Name: Sandostatine
Product Name: sandostatine
Trade Name: Sandostatine
Product Name: sandostatine
Gastroenterology CHC LiegeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
1434EUCTR2009-010727-91-DE
(EUCTR)
01/03/201105/06/2012Colesevelam, which is a medication which binds bile acid, to test in patients with Crohns diseaseColesevelam for the treatment of bile acid malabsorption in patients with Crohn’s disease (Colesevelam für die Therapie der Gallensäuren-Malabsorption bei M. Crohn-Patienten) Morbus Crohn
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Cholestagel
Product Name: Cholestagel
Product Code: EU/1/03/268/002
INN or Proposed INN: Colesevelam
LMU München, Campus GroßhadernNULLNot RecruitingFemale: yes
Male: yes
Germany
1435JPRN-UMIN000005146
2011/03/0125/02/2011Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) Crohn's diseaseAdministration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azathioprine up to 4 weeks and not increase in dosage later
Department of Internal Medicine, School of Medicine, Keio UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female200Phase 4Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1436EUCTR2010-022383-12-SE
(EUCTR)
01/03/201115/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
1437EUCTR2010-022384-35-SE
(EUCTR)
01/03/201115/12/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
1438NCT01258205
(ClinicalTrials.gov)
February 28, 20119/12/2010Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease SubjectsA Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's DiseaseCrohn's DiseaseDrug: AMG 139AllerganNULLCompleted18 Years55 YearsAll48Phase 1United States;Australia
1439EUCTR2010-022383-12-GB
(EUCTR)
24/02/201123/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;Norway;Sweden
1440EUCTR2009-016488-12-SK
(EUCTR)
23/02/201127/10/2010A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Czech Republic;Hungary;Slovakia;Belgium;Austria;Germany;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1441EUCTR2010-022382-10-NL
(EUCTR)
16/02/201129/10/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: GSK1605786A
Product Code: GSK1605786A
Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600Hungary;Czech Republic;Spain;Belgium;Austria;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden
1442EUCTR2010-022383-12-NL
(EUCTR)
16/02/201129/10/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
Other descriptive name: na
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
750United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden
1443EUCTR2010-024528-12-DK
(EUCTR)
14/02/201124/01/2011Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULTKontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT Morbus Crohn disease with signs of activity in the small bowel.
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: SonoVue
Other descriptive name: SULFUR HEXAFLUORIDE
Henning GlerupNULLNot RecruitingFemale: yes
Male: yes
5Denmark
1444NCT01235689
(ClinicalTrials.gov)
February 11, 20114/11/2010Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's DiseaseAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Adalimumab;Drug: Prednisone;Drug: AzathioprineAbbVie (prior sponsor, Abbott)NULLCompleted18 Years75 YearsAll252Phase 3Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
1445EUCTR2010-019996-32-CZ
(EUCTR)
11/02/201126/11/2010A phase II, randomized, double-blind, placebo-controlled study toevaluate the clinical efficacy, safety and immunogenicity ofNeovacs'TNFa-Kinoid in adult subjects with Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
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]
Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1446EUCTR2009-016488-12-BE
(EUCTR)
08/02/201125/11/2010A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Czech Republic;Hungary;Slovakia;Belgium;Austria;Germany;Netherlands;Italy
1447EUCTR2010-022382-10-BE
(EUCTR)
07/02/201107/12/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
1448EUCTR2009-016488-12-CZ
(EUCTR)
04/02/201125/11/2010A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Netherlands;Italy
1449EUCTR2010-022384-35-DE
(EUCTR)
02/02/201110/11/2010A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s diseaseAn Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study Subjects with Crohn’s Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
800Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
1450NCT01287897
(ClinicalTrials.gov)
February 201131/1/2011A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF TherapyA Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)Crohn's DiseaseDrug: PF-04236921 SC injectionPfizerNULLCompleted18 Years75 YearsAll250Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;New Zealand;Romania;Switzerland;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1451NCT01203631
(ClinicalTrials.gov)
February 201115/9/2010Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's DiseaseA Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's DiseaseInflammation;Crohn's DiseaseDrug: NNC 0142-0000-0002;Drug: PlaceboJanssen Research & Development, LLCNULLCompleted18 Years75 YearsBoth78Phase 2United States;Belgium;Canada;France;Hungary;Israel;Poland;Russian Federation
1452NCT01290042
(ClinicalTrials.gov)
February 201127/1/2011Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.Ulcerative Colitis;Crohn's DiseaseDrug: AMG 181;Other: Placebo for AMG 181AmgenNULLCompleted18 Years65 YearsBoth43Phase 1United States;Australia
1453NCT01291810
(ClinicalTrials.gov)
February 201117/12/2010Clinical Efficacy of TNFa Kinoid in Crohn's Disease PatientsA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's DiseaseCrohn's DiseaseBiological: TNF Kinoid;Biological: WFINeovacsNULLCompleted18 Years65 YearsBoth66Phase 2Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania
1454EUCTR2010-022382-10-SE
(EUCTR)
20/01/201109/11/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
1455EUCTR2010-022382-10-DK
(EUCTR)
19/01/201110/12/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1456EUCTR2010-020881-53-BE
(EUCTR)
18/01/201124/11/2010Safety Study in Subjects With Crohn's DiseaseA Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
195Phase 2France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands
1457EUCTR2010-019973-13-DE
(EUCTR)
14/01/201130/09/2010A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsA multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease Treatment of perianal fistulas in patients suffering from Crohn's Disease.
MedDRA version: 14.0;Level: PT;Classification code 10016717;Term: Fistula;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Code: QAX576
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
23Phase 2Germany;Switzerland
1458EUCTR2010-019996-32-BE
(EUCTR)
12/01/201104/10/2010A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
1459EUCTR2010-022382-10-DE
(EUCTR)
11/01/201122/10/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Japan;Sweden
1460EUCTR2010-020836-21-BE
(EUCTR)
07/01/201115/09/2010A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s diseaseA randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease Crohn’s disease
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]
Product Name: NNC0142-0000-0002
Product Code: NNC142-0002
INN or Proposed INN: N/A
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Hungary;European Union;Canada;Poland;Belgium;Israel;Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1461EUCTR2010-022017-26-GB
(EUCTR)
07/01/201108/12/2010A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s diseaseA pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease Crohn's disease
MedDRA version: 12.;Level: LLT;Classification code 10013099;Term: Disease Crohns
Central Manchester University Hospitals Foundation TrustNULLNot Recruiting Female: yes
Male: yes
27Phase 2United Kingdom
1462EUCTR2010-022382-10-GB
(EUCTR)
06/01/201112/10/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
1463EUCTR2010-019544-39-NL
(EUCTR)
06/01/201130/08/2010A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease Crohn’s disease
MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated
Product Name: AMG 827
Product Code: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
216Netherlands;Belgium;France;Spain
1464EUCTR2010-022383-12-NO
(EUCTR)
06/01/201102/12/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden
1465EUCTR2009-016488-12-AT
(EUCTR)
05/01/201118/11/2010Study of Vedolizumab in Patients With Moderate to Severe Crohn's DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3United States;Slovakia;Turkey;Austria;Israel;Italy;France;Hungary;Czech Republic;Canada;Malaysia;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1466NCT01245088
(ClinicalTrials.gov)
January 201119/11/2010Chondroitin Sulfate for Crohn's DiseaseA Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's DiseaseCrohn's DiseaseDrug: chondroitin sulfateUniversity Hospital Case Medical CenterNULLWithdrawn18 Years80 YearsBoth0Phase 1;Phase 2United States
1467EUCTR2009-016488-12-HU
(EUCTR)
28/12/201010/11/2010A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
396Phase 3Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy
1468EUCTR2010-022382-10-CZ
(EUCTR)
22/12/201004/11/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
600United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden
1469NCT01277666
(ClinicalTrials.gov)
December 20, 201013/1/2011A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's DiseaseA Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn's DiseaseDrug: GSK1605786A;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll608Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Czech Republic
1470EUCTR2010-020137-10-NL
(EUCTR)
17/12/201023/12/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240Phase 3Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1471EUCTR2010-018431-18-IT
(EUCTR)
03/12/201010/01/2011Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENTProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn`s disease (DS)
MedDRA version: 9.1;Level: LLT;Classification code 10011401
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
CENTOCORNULLNot RecruitingFemale: yes
Male: yes
290France;Czech Republic;Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Italy
1472NCT01199302
(ClinicalTrials.gov)
December 20109/9/2010Safety Study in Subjects With Crohn's DiseaseA Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: AMG 827AmgenNULLTerminatedN/AN/ABoth67Phase 2United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain
1473NCT01233960
(ClinicalTrials.gov)
November 29, 20102/11/2010Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's DiseaseA Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's DiseaseCrohn's DiseaseDrug: adult human mesenchymal stem cellsMesoblast, Inc.NULLCompleted18 Years70 YearsAll73Phase 3United States;Australia;New Zealand
1474EUCTR2010-019544-39-ES
(EUCTR)
25/11/201003/09/2010Estudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's DiseaseEstudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease Crohn's disease / Enfermedad de Crohn
MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated
Product Name: AMG 827
Product Code: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
216Netherlands;Belgium;France;Spain
1475EUCTR2010-018431-18-BE
(EUCTR)
19/11/201028/07/2010A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 16.1;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: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1476EUCTR2010-020137-10-CZ
(EUCTR)
08/11/201004/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
1477EUCTR2010-020137-10-IT
(EUCTR)
07/11/201008/11/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM Crohn`s disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401
Abbott GmBH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240Phase 3France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
1478NCT01279577
(ClinicalTrials.gov)
November 201018/1/2011Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's DiseaseDouble-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's DiseaseCrohn´s DiseaseDrug: Low dose TSO;Drug: Medium dose TSO;Drug: High dose TSO;Drug: PlaceboDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth254Phase 2Germany
1479NCT01190839
(ClinicalTrials.gov)
November 201012/8/2010A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of RecurrenceCrohn's DiseaseBiological: Infliximab;Drug: PlaceboJanssen Biotech, Inc.NULLTerminated18 Years99 YearsAll297Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;New Zealand;Poland;United Kingdom;Denmark;Spain
1480NCT01224171
(ClinicalTrials.gov)
November 201018/10/2010Study of Vedolizumab in Patients With Moderate to Severe Crohn's DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: vedolizumab;Other: PlaceboMillennium Pharmaceuticals, Inc.NULLCompleted18 Years80 YearsAll416Phase 3United States;Canada;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1481NCT01094613
(ClinicalTrials.gov)
November 201025/3/2010Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's DiseaseMultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's DiseaseCrohn's DiseaseDrug: Delayed Release 6 mercaptopurine;Drug: 6 MercaptopurineTeva GTCNULLTerminated18 Years75 YearsBoth70Phase 1;Phase 2Israel
1482EUCTR2010-018431-18-NL
(EUCTR)
28/10/201020/09/2010A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 16.1;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: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
1483JPRN-UMIN000005761
2010/10/2713/06/2011The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
Kenji WatanabeNULLComplete: follow-up completeNot applicableNot applicableMale and Female50Not selectedJapan
1484EUCTR2006-000720-13-DE
(EUCTR)
27/10/201029/01/2010Study to evaluate the effectiveness and safety of 3 doses of embryonated eggs of the porcine whipworm compared to placebo (dummy drug) in the treatment of active Crohn's disease.Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease Induction of remission in active Crohn´s disease
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]
Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Czech Republic;Denmark;Austria;Germany;Switzerland
1485JPRN-UMIN000005762
2010/10/2713/06/2011The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.1)Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.

2)Elental(1 kcal/ml; 80g/300ml)
Kenji WatanabeNULLComplete: follow-up completeNot applicableNot applicableMale and Female40Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1486EUCTR2010-020836-21-HU
(EUCTR)
26/10/201028/09/2010A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s diseaseA randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: NNC0142-0000-0002
Product Code: NNC142-0002
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
150Hungary;Poland;Belgium
1487EUCTR2006-002078-23-IE
(EUCTR)
20/10/201025/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1488EUCTR2010-020137-10-ES
(EUCTR)
20/10/201020/08/2010Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALMEstudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Enfermedad de Crohn.Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
1489EUCTR2006-000720-13-CZ
(EUCTR)
18/10/201030/06/2010Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Czech Republic;Denmark;Austria;Germany;Switzerland
1490EUCTR2010-020137-10-FR
(EUCTR)
14/10/201023/08/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Abbott GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240Phase 3France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1491EUCTR2010-020137-10-DE
(EUCTR)
05/10/201020/07/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
1492EUCTR2010-019544-39-BE
(EUCTR)
04/10/201017/08/2010AMG 827 in Subjects With Moderate to Severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease Crohn’s disease
MedDRA version: 14.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
216Phase 2France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands
1493EUCTR2010-019544-39-FR
(EUCTR)
04/10/201006/09/2010A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease Crohn’s disease
MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated
Product Name: AMG 827
Product Code: AMG 827
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
216Netherlands;Belgium;France;Spain
1494NCT01231217
(ClinicalTrials.gov)
October 201027/10/2010Green Tea in Crohn's DiseaseCrohn's DiseaseOther: Green tea (Camellia sinensis);Other: CoffeeUniversity Hospital HeidelbergNULLRecruiting18 YearsN/ABoth80N/AGermany
1495NCT01111292
(ClinicalTrials.gov)
October 201024/4/2010Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated DysplasiaMyo-Inositol Chemoprevention in Colitis-Associated DysplasiaColon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal CarcinomaDrug: Inositol;Other: PlaceboNational Cancer Institute (NCI)NULLTerminated18 YearsN/AAll5Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1496NCT01203254
(ClinicalTrials.gov)
October 201015/9/2010Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's DiseaseColesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's DiseaseCrohns Disease;Bile Acid MalabsorptionDrug: Colesevelam;Drug: PlaceboFlorian BeigelNULLTerminated18 Years65 YearsBoth34Phase 4Germany
1497EUCTR2010-020137-10-GB
(EUCTR)
20/09/201019/07/2010 Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
1498EUCTR2010-020137-10-AT
(EUCTR)
16/09/201011/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
1499EUCTR2010-020137-10-SE
(EUCTR)
15/09/201027/07/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
1500EUCTR2010-018431-18-FR
(EUCTR)
15/09/201009/07/2010Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENTProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Centocor BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1501NCT01215890
(ClinicalTrials.gov)
September 20105/10/2010Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's DiseaseA Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease PatientsCrohn's Disease;Low Bone Mineral DensityDrug: risedronate;Drug: placeboUniversity of AlbertaNULLCompleted18 YearsN/ABothPhase 4Canada
1502NCT01233570
(ClinicalTrials.gov)
September 20102/11/2010Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's DiseaseTopical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's DiseaseCrohn DiseaseDrug: TacrolimusUniversity of AberdeenNULLCompleted12 YearsN/ABoth20Phase 2United Kingdom
1503EUCTR2010-018431-18-DE
(EUCTR)
23/08/201024/06/2010A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 16.1;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: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
1504EUCTR2010-018431-18-GB
(EUCTR)
16/08/201006/07/2010A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Janssen Biologics B.V.NULLNot Recruiting Female: yes
Male: yes
290Phase 3Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
1505EUCTR2010-018431-18-AT
(EUCTR)
06/08/201005/07/2010A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of RecurrenceProspective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT Crohn’s disease (CD)
MedDRA version: 17.0;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: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1506NCT01261286
(ClinicalTrials.gov)
August 201014/12/2010Drug-Disease Interaction in Crohn's DiseasePharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease PatientsCrohn's DiseaseDrug: verapamilUniversity of AlbertaNULLCompleted18 Years65 YearsBothPhase 1Canada
1507NCT01190410
(ClinicalTrials.gov)
August 201025/8/2010Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab PegolAn Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035Crohn's DiseaseDrug: certolizumab pegolUCB PharmaNULLCompleted6 Years17 YearsAll16Phase 2United States;Australia;Canada
1508NCT01611805
(ClinicalTrials.gov)
July 22, 201012/4/2012Japanese Phase I of GSK1605786A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male SubjectCrohn's DiseaseDrug: GSK1605786;Drug: GSK1605786 PlaceboGlaxoSmithKlineNULLCompleted20 Years55 YearsMale30Phase 1Australia
1509NCT01150890
(ClinicalTrials.gov)
July 201024/6/2010AMG 827 in Subjects With Moderate to Severe Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: AMG 827 350 MG;Drug: AMG 827 210 MG;Drug: AMG 827 700 MG;Drug: PlaceboAmgenNULLTerminated18 Years65 YearsBoth130Phase 2United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain
1510NCT01510431
(ClinicalTrials.gov)
July 20109/1/2012Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's DiseaseAn Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's DiseaseCrohn's DiseaseDrug: PROCHYMAL (remestemcel-L)Mesoblast, Inc.NULLNo longer available18 Years70 YearsAllUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1511EUCTR2006-000720-13-DK
(EUCTR)
22/06/201017/03/2010Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease Induction of remission in active Crohn´s disease
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]
Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Czech Republic;Austria;Denmark;Germany;Switzerland
1512EUCTR2009-015680-14-NL
(EUCTR)
18/05/201027/07/2010Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistulaAllogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula single or multiple draining perianal fistulas as a result of Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Bone Marrow Derived Mesenchymal Stem cells (MSCs)
Product Code: NA
Leiden University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
Netherlands
1513EUCTR2009-011621-14-DE
(EUCTR)
12/05/201026/01/2010A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/aA 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/a Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: AIN457
Product Code: AIN457
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Germany;Austria
1514NCT01114607
(ClinicalTrials.gov)
May 5, 201029/4/2010A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy SubjectsA Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female SubjectsCrohn's DiseaseDrug: GSK1605786 ChemoCentryx: formulation A;Drug: GSK1605786 GSK: formulation B;Drug: GSK1605786 GSK direct-fill: formulation C;Drug: GSK1605786 GSK modified-process: formulation D;Drug: GSK1605786 GSK tablet: formulation EGlaxoSmithKlineNULLCompleted18 Years55 YearsAll24Phase 1United States
1515NCT00737932
(ClinicalTrials.gov)
May 201018/8/2008Laquinimod Phase IIa Study in Active Crohn's DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.Crohn's DiseaseDrug: Laquinimod;Other: placeboTeva Pharmaceutical IndustriesNULLCompleted18 Years75 YearsBoth180Phase 2Belgium;France;Israel;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1516EUCTR2008-005903-25-BG
(EUCTR)
23/04/201014/04/2010Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS
Product Name: SC12267
Product Code: SC12267
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
4SC AGNULLNot RecruitingFemale: yes
Male: yes
24Germany;Bulgaria
1517EUCTR2006-000720-13-AT
(EUCTR)
07/04/201003/03/2010Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease Induction of remission in active Crohn´s disease
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]
Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Czech Republic;Denmark;Austria;Germany;Switzerland
1518EUCTR2008-002784-14-GB
(EUCTR)
26/03/201028/06/2010 An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe Ltd.NULLNot Recruiting Female: yes
Male: yes
2200Phase 3Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1519EUCTR2008-002784-14-SE
(EUCTR)
12/02/201023/01/2009An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1520NCT00988832
(ClinicalTrials.gov)
February 20101/10/2009An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)A UK Retrospective Audit of Patients With Crohn's Disease Treated With InfliximabCrohn's DiseaseBiological: InfliximabMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll380N/AUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1521NCT01037322
(ClinicalTrials.gov)
January 201020/12/2009Cannabidiol for Inflammatory Bowel DiseaseUse of Cannabidiol for the Treatment of Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: cannabidiol;Drug: placebo in dropsMeir Medical CenterNULLCompleted20 Years80 YearsBoth20Phase 1;Phase 2Israel
1522NCT01548014
(ClinicalTrials.gov)
January 201017/2/2012The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's DiseaseReduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot StudyCrohn's DiseaseDietary Supplement: VSL#3Samsung Medical CenterNULLRecruiting13 Years17 YearsBoth1Phase 3Korea, Republic of
1523NCT01288053
(ClinicalTrials.gov)
January 201027/1/2011Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's DiseaseNon-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's DiseaseCrohn's DiseaseBiological: Allogeneic Stem Cell TherapyNorthwestern UniversityNULLTerminated18 Years45 YearsAll9Phase 1;Phase 2United States
1524NCT01040910
(ClinicalTrials.gov)
January 201029/12/2009Cannabis for Inflammatory Bowel DiseaseA Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: smoking of cannabis;Drug: smoking cigarettes with placeboMeir Medical CenterNULLRecruiting20 Years70 YearsBoth20Phase 1;Phase 2Israel
1525EUCTR2007-006494-90-GB
(EUCTR)
24/12/200918/06/2009A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 StudyA Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Abbott GmbH & Co. K.G.NULLNot Recruiting Female: yes
Male: yes
100Phase 3Czech Republic;Belgium;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1526EUCTR2008-005237-30-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
1527EUCTR2008-006957-42-BG
(EUCTR)
17/11/200921/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania
1528EUCTR2009-011621-14-AT
(EUCTR)
12/11/200919/10/2009A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1 Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: Not available
Other descriptive name: None
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Germany;Austria
1529JPRN-UMIN000002796
2009/11/0125/11/2009Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial. Crohn's diseaseWe randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks.
For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml).
placebo control
Department of Gastroenterology and Hepatology, Kyoto UniversityNULLRecruiting16years-old65years-oldMale and Female50Phase 2Japan
1530NCT01015391
(ClinicalTrials.gov)
November 200917/11/2009Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's DiseaseA Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical ResectionCrohn's DiseaseDrug: T2;Drug: AzathioprineJinling Hospital, ChinaNULLRecruiting18 YearsN/ABoth100N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1531NCT01086553
(ClinicalTrials.gov)
November 200912/3/20109 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's DiseaseDouble-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's DiseaseCrohn´s DiseaseDrug: budesonideDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth471Phase 3Germany
1532EUCTR2008-006957-42-DE
(EUCTR)
30/10/200930/07/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;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
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany
1533EUCTR2009-011220-62-NL
(EUCTR)
26/10/200913/07/2009A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN studyA randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: mesalazine
INN or Proposed INN: mesalazine
Other descriptive name: AMINOSALICYLIC ACID
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
Netherlands
1534EUCTR2008-006957-42-LT
(EUCTR)
19/10/200912/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania
1535EUCTR2008-006957-42-SK
(EUCTR)
14/10/200919/10/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1536NCT01661257
(ClinicalTrials.gov)
October 20097/8/2012Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a TherapyExpression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a TherapyCrohn's DiseaseDrug: InfliximabSamsung Medical CenterNULLCompleted13 Years17 YearsBoth20Phase 3Korea, Republic of
1537NCT01009281
(ClinicalTrials.gov)
October 20095/11/2009An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's DiseaseA 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's DiseaseCrohn's Disease;Inflammatory Bowel DiseaseDrug: AIN457Novartis PharmaceuticalsNULLTerminated18 Years75 YearsAll7Phase 2United States;Austria;Canada;Germany;Poland
1538NCT00989573
(ClinicalTrials.gov)
October 20092/10/2009A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's DiseaseA Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: OPC-6535Otsuka Pharmaceutical Co., Ltd.NULLCompleted18 Years64 YearsBoth191Phase 2;Phase 3Japan;Korea, Republic of
1539EUCTR2008-006957-42-LV
(EUCTR)
25/09/200908/09/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia
1540EUCTR2008-006957-42-CZ
(EUCTR)
24/09/200907/09/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1541EUCTR2008-006957-42-HU
(EUCTR)
16/09/200904/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania
1542EUCTR2008-008359-40-DE
(EUCTR)
08/09/200923/06/2009A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202 Moderate to severe Crohn's disease (CDAI >/= 220 and MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's diseaseProduct Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Germany;Poland;Austria
1543EUCTR2008-002784-14-DE
(EUCTR)
02/09/200902/06/2009An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia
1544EUCTR2008-008359-40-PL
(EUCTR)
02/09/200907/04/2009A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: AIN457
Product Code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class) rhumAb to Il-17A (IgG1-k-class)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Germany;Austria;Poland
1545NCT00999115
(ClinicalTrials.gov)
September 200920/10/2009Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA)Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s DiseaseRectovaginal Fistula;Crohn DiseaseDrug: Expanded allogenic adipose-derived adult stem cellsFundacion para la Investigacion Biomedica del Hospital Universitario la PazNULLCompleted18 YearsN/AFemale10Phase 1;Phase 2Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1546NCT02322008
(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
1547EUCTR2008-002783-33-DE
(EUCTR)
24/08/200923/04/2009Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1116Phase 3Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Norway;Germany;New Zealand;Sweden
1548EUCTR2008-002784-14-AT
(EUCTR)
13/08/200928/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1549EUCTR2009-013348-35-NL
(EUCTR)
04/08/200903/07/2009(Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease(Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease Patients with quiescent Crohn’s colitis, defined as a Crohn’s Disease Activity Index <150 ; non-IBD patients will serve as disease controls.
MedDRA version: 9.1;Level: LLT;Classification code 10011400;Term: Crohn's colitis
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10011402;Term: Crohn's disease (colon)
Trade Name: Chenofalk
Product Name: Chenofalk
Product Code: RVG 07151
INN or Proposed INN: CHENODEOXYCHOLIC ACID
Other descriptive name: Chenodiol
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
Netherlands
1550NCT01012570
(ClinicalTrials.gov)
August 200911/11/2009The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) PatientsCrohn's DiseaseDrug: Application of AdalimumabGerhard RoglerNULLTerminated18 Years65 YearsBoth34Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1551NCT00367705
(ClinicalTrials.gov)
August 200922/8/2006VSL#3 Treatment in Children With Crohn's DiseaseDouble-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's DiseaseCrohn's DiseaseDietary Supplement: VSL#3®;Dietary Supplement: PlaceboHadassah Medical OrganizationNULLNot yet recruiting6 Years18 YearsBoth300Phase 4Israel
1552EUCTR2008-007329-38-ES
(EUCTR)
24/07/200924/04/2009Estudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s DiseaseEstudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease Pacientes con enfermedad de Crohn dependiente de esteroides
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
INN or Proposed INN: fosfato sodico de dexametasona
ERYDEL S.P.A.NULLNot RecruitingFemale: yes
Male: yes
184Spain;Italy
1553EUCTR2009-011763-37-IT
(EUCTR)
22/07/200916/04/2009THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - NDTHE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - ND Crohn`s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10038283;Term: Regional enteritis of small intestine with large intestine
INN or Proposed INN: AdalimumabISTITUTO CLINICO HUMANITASNULLNot RecruitingFemale: yes
Male: yes
Italy
1554EUCTR2008-002783-33-IT
(EUCTR)
22/07/200917/03/2009Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - NDPhase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - ND Patients with Moderate to Severe Crohn?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Vedolizumab
Product Code: MLN0002
MILLENNIUM PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1555EUCTR2008-002783-33-GB
(EUCTR)
20/07/200927/11/2008 A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Millennium Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1556EUCTR2008-002783-33-CZ
(EUCTR)
13/07/200931/10/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1557EUCTR2008-005688-32-CZ
(EUCTR)
02/07/200905/01/2009Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region. Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions).
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Univeristy Hospital Na BulovceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50Phase 3Czech Republic
1558JPRN-UMIN000002074
2009/07/0101/07/2009Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL Crohn's diseaseRosuvastatin (Crestor) 0mg/day: Control group
Rosuvastatin (Crestor) 5mg/day: Low-dose group
Rosuvastatin (Crestor) 20mg/day: High-dose group
Department of lower gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete20years-old65years-oldMale and Female45Phase 2Japan
1559NCT00950105
(ClinicalTrials.gov)
July 200929/7/2009Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Oral CPSI-2364 in Healthy SubjectsCrohn's DiseaseDrug: CPSI-2364 or placeboFerring PharmaceuticalsNULLCompleted18 Years55 YearsBoth30Phase 1United States
1560EUCTR2008-002783-33-GR
(EUCTR)
18/06/200905/11/2009A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1561EUCTR2009-010163-16-GB
(EUCTR)
05/06/200918/08/2009Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease - Bile salt manipulation in Crohn’s diseaseBile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease - Bile salt manipulation in Crohn’s disease Active Crohn's disease affecting the ileum
MedDRA version: 9.1;Level: LLT;Classification code 10011406;Term: Crohn's ileitis
MedDRA version: 9.1;Classification code 10058815;Term: Crohn's disease acute episode
University College LondonNULLNot Recruiting Female: yes
Male: yes
13Phase 2United Kingdom
1562EUCTR2006-004784-58-GB
(EUCTR)
03/06/200930/04/2009An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF studyAn Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
University of Leuven HospitalsNULLNot RecruitingFemale: yes
Male: yes
25Phase 4France;Belgium;Germany;United Kingdom
1563NCT01372969
(ClinicalTrials.gov)
June 200930/8/2010Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.Crohn's Disease;Anal FistulaDrug: Cx601Tigenix S.A.U.NULLCompleted18 YearsN/AAll24Phase 1;Phase 2Spain
1564NCT00790933
(ClinicalTrials.gov)
May 22, 20095/11/2008An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaNULLCompleted18 YearsN/AAll2243Phase 3United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic
1565EUCTR2008-004919-36-AT
(EUCTR)
20/05/200910/11/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2BDenmark;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1566EUCTR2008-008359-40-AT
(EUCTR)
07/05/200931/03/2009A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: AIN457
Product Code: AIN457
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Germany;Poland;Austria
1567JPRN-UMIN000002604
2009/05/0101/11/2009Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease Crohn's diseasePatients are randomly divided into two groups, groups treated with or without infliximab by staffs of Keio Clinical Research Center at 2 to 4 weeks after surgery.
Patients receive infliximab 5 mg/kg at 0, 2, 6 weeks, followed by every 8 weeks for 2 years. Alternatively, patients continue to receive infliximab with intervals of 8 weeks if they received infliximab within 8 weeks from the time point 0.
Patients without infliximab receive maintenance therapy without immunomodulators.
Clinical Research Group of inflammatory bowel disease in JapanNULLComplete: follow-up complete18years-oldNot applicableMale and Female100Phase 4Japan
1568NCT00889161
(ClinicalTrials.gov)
May 200924/4/2009Curcumin in Pediatric Inflammatory Bowel DiseaseCurcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration StudyInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: CurcuminSeattle Children's HospitalNULLCompleted8 Years18 YearsBoth11Phase 1United States
1569NCT00742781
(ClinicalTrials.gov)
May 200926/8/2008Vitamin D Supplementation in Crohn's PatientsVitamin D and Crohn's Disease From the Bench to the ClinicInflammatory Bowel DiseaseDietary Supplement: Vitamin DPenn State UniversityNULLCompleted18 Years70 YearsAll21Phase 1United States
1570EUCTR2008-004286-25-DE
(EUCTR)
28/04/200921/08/2008Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT IIRandomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT II Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
196Phase 3Czech Republic;Germany;Netherlands;Belgium;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1571EUCTR2008-002784-14-EE
(EUCTR)
28/04/200927/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia
1572EUCTR2008-002784-14-BE
(EUCTR)
21/04/200914/11/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1573EUCTR2008-002784-14-HU
(EUCTR)
20/04/200927/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
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]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1574EUCTR2008-007519-34-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
1575EUCTR2008-006484-36-IT
(EUCTR)
16/04/200924/04/2009MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASEMULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE Moderate-to-severe active Crohn`sdisease.
MedDRA version: 9.1;Level: LLT;Classification code 10011398;Term: Crohn's
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMANULLNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1576EUCTR2008-002783-33-SE
(EUCTR)
15/04/200922/01/2009A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1577EUCTR2008-002783-33-HU
(EUCTR)
14/04/200927/10/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1578EUCTR2008-002784-14-GR
(EUCTR)
07/04/200905/11/2009A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1508Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1579NCT01277289
(ClinicalTrials.gov)
April 20095/1/2011Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's DiseaseMulticenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's DiseaseCrohn's DiseaseDrug: DexamethasoneErydelNULLTerminated18 Years80 YearsBoth51Phase 3Italy;Romania;Spain
1580NCT00862121
(ClinicalTrials.gov)
April 200913/3/2009A Study With Pentasa in Patients With Active Crohn's DiseasePENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.Crohn´s DiseaseDrug: Pentasa;Drug: PlaceboFerring PharmaceuticalsNULLTerminated18 YearsN/AAll20Phase 3United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1581NCT00899678
(ClinicalTrials.gov)
April 200929/4/2009The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and AdolescentsA Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)Crohn's DiseaseDrug: Certolizumab PegolUCB CelltechNULLTerminated6 Years17 YearsAll99Phase 2United States;Australia;Canada;New Zealand
1582EUCTR2008-004286-25-BE
(EUCTR)
30/03/200911/09/2008Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT IIRandomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT II Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
196Phase 3Czech Republic;Germany;Netherlands;Belgium;Spain;Austria
1583EUCTR2009-009926-94-DK
(EUCTR)
26/03/200925/02/2009Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapyUse of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy Patients with Crohns diseases failing treatment with infliximab
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
Trade Name: Humira
Department of medical gastroenterology, Herlev HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
1584EUCTR2008-002783-33-FR
(EUCTR)
23/03/200914/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1060Phase 3Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Denmark;Estonia;Spain;Greece
1585EUCTR2008-002784-14-FR
(EUCTR)
23/03/200914/11/2008A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns
Millennium Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
1508Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1586EUCTR2008-004919-36-SE
(EUCTR)
11/03/200911/12/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2BDenmark;Austria;Sweden
1587EUCTR2008-000649-77-DE
(EUCTR)
11/03/200926/09/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2bUnited Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
1588EUCTR2008-002783-33-PT
(EUCTR)
06/03/200906/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1589EUCTR2008-002784-14-PT
(EUCTR)
06/03/200906/11/2008A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1508Phase 3Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece
1590NCT00820365
(ClinicalTrials.gov)
March 20099/1/2009SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel DiseaseExploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Inflammatory Bowel Disease (IBD)Drug: SC12267 (4SC-101)4SC AGNULLCompleted18 Years70 YearsBoth34Phase 2Bulgaria;Germany;Romania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1591EUCTR2007-005455-42-NL
(EUCTR)
26/02/200918/09/2008ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIALENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIAL Crohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction.
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Budenofalk
Product Name: Budenofalk
INN or Proposed INN: BUDESONIDE
Trade Name: Kenacort
Product Name: Kenacort
INN or Proposed INN: TRIAMCINOLONE
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
42Netherlands
1592EUCTR2008-002784-14-CZ
(EUCTR)
20/02/200931/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1593EUCTR2008-002783-33-NL
(EUCTR)
18/02/200905/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland;Sweden
1594EUCTR2008-003571-45-GB
(EUCTR)
18/02/200916/07/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Limited, Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1595EUCTR2008-002784-14-NL
(EUCTR)
18/02/200905/11/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1596EUCTR2008-000649-77-FR
(EUCTR)
16/02/200907/12/2009A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 2bUnited Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
1597EUCTR2007-006494-90-CZ
(EUCTR)
11/02/200907/11/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Canada;Belgium;Poland;United Kingdom
1598EUCTR2008-000649-77-NL
(EUCTR)
06/02/200912/09/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2bUnited Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
1599EUCTR2008-007329-38-IT
(EUCTR)
06/02/200921/01/2009Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s DiseaseMulticenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease Patients with steroid-dependent Crohn?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
INN or Proposed INN: dexamethasone sodium phosphate
ERYDEL S.P.A.NULLNot RecruitingFemale: yes
Male: yes
184Spain;Italy
1600EUCTR2008-002783-33-BE
(EUCTR)
05/02/200914/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1601NCT00245505
(ClinicalTrials.gov)
February 200926/10/2005The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's DiseaseThe Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot StudyCrohn's DiseaseDrug: Mesalazine (Mesalamine)Ferring PharmaceuticalsNULLTerminated18 Years70 YearsBoth3Phase 3Sweden
1602EUCTR2006-005526-23-GB
(EUCTR)
29/01/200927/04/2009Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2 - Plantain NSP in Crohn's diseaseRandomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2 - Plantain NSP in Crohn's disease Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Provexis PlcNULLNot Recruiting Female: yes
Male: yes
76Phase 2United Kingdom
1603EUCTR2008-002783-33-AT
(EUCTR)
29/01/200928/10/2008Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis Moderate to Severe Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden
1604EUCTR2008-002784-14-MT
(EUCTR)
28/01/200925/11/2008A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1508Phase 3Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece
1605EUCTR2008-002783-33-MT
(EUCTR)
28/01/200925/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative ColitisA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1606EUCTR2008-002100-26-BE
(EUCTR)
28/01/200931/07/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
1607EUCTR2008-000649-77-ES
(EUCTR)
27/01/200929/10/2008Estudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFIEstudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFI Enfermedad de Crohn activa de moderada a grave
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
1608EUCTR2008-002784-14-IS
(EUCTR)
27/01/200906/11/2008An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
1508Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden
1609EUCTR2008-004919-36-DK
(EUCTR)
23/01/200918/12/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2BDenmark;Austria;Sweden
1610EUCTR2008-000649-77-GB
(EUCTR)
23/01/200903/10/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2bGermany;United Kingdom;Netherlands;Belgium;France;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1611EUCTR2008-004919-36-BE
(EUCTR)
20/01/200914/11/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2BBelgium;Denmark;Austria;Sweden
1612EUCTR2008-003571-45-CZ
(EUCTR)
20/01/200920/01/2009A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
136Hungary;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy
1613EUCTR2008-002784-14-BG
(EUCTR)
16/01/200912/01/2009An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
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]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1614EUCTR2008-002100-26-FR
(EUCTR)
16/01/200902/09/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placeboPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
1615EUCTR2008-002783-33-BG
(EUCTR)
16/01/200913/01/2009A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1616EUCTR2006-004814-41-GB
(EUCTR)
16/01/200907/03/2008A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Trade Name: Humira 40 mg solution for injection in pre-filled pen
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom
1617EUCTR2008-002783-33-SK
(EUCTR)
15/01/200928/10/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1618EUCTR2008-002784-14-SK
(EUCTR)
15/01/200928/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1619EUCTR2008-002783-33-IS
(EUCTR)
13/01/200906/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden
1620EUCTR2008-002784-14-IE
(EUCTR)
09/01/200928/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1621EUCTR2008-002783-33-EE
(EUCTR)
09/01/200927/10/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1622EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
1623EUCTR2008-002783-33-IE
(EUCTR)
09/01/200928/10/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1624EUCTR2008-005903-25-DE
(EUCTR)
08/01/200903/11/2008Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS
Product Name: SC12267
Product Code: SC12267
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
4SC AGNULLNot RecruitingFemale: yes
Male: yes
35Bulgaria;Germany
1625EUCTR2008-002100-26-GB
(EUCTR)
07/01/200919/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1626EUCTR2008-000649-77-BE
(EUCTR)
05/01/200920/10/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2bUnited Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
1627NCT00844285
(ClinicalTrials.gov)
January 200913/2/2009SECURE, the Cimzia ® Crohn's Disease Post-Marketing RegistryA Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's DiseaseCrohn's DiseaseDrug: CimziaUCB PharmaNULLCompleted18 YearsN/AAll3045United States
1628NCT01429922
(ClinicalTrials.gov)
January 200929/8/2011Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending DoseDouble Blind Placebo-controlled,Safety and Tolerability of ZP1848 Administered as Ascending Single Dose SUBCUTANEOUS Bolus Injections in Healthy Subjects Followed by Multiple Dose Cohort of Patients With Stable Crohn's Disease in RemissionCrohns DiseaseDrug: ZP1848MDS Pharma ServicesNULLCompleted18 Years50 YearsBoth60Phase 1;Phase 2United States
1629EUCTR2008-002784-14-LV
(EUCTR)
19/12/200831/10/2008An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseaseA Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;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]
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Takeda Development Centre Europe Ltd.NULLNot RecruitingFemale: yes
Male: yes
2200Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1630EUCTR2008-002783-33-LV
(EUCTR)
19/12/200831/10/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1631EUCTR2008-004276-49-FR
(EUCTR)
18/12/200821/07/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
199Phase 2aUnited Kingdom;Netherlands;Belgium;France;Spain;Italy
1632EUCTR2008-002783-33-DK
(EUCTR)
18/12/200807/11/2008A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
1060Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1633EUCTR2008-003571-45-NL
(EUCTR)
17/12/200825/11/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1634EUCTR2007-002716-26-EE
(EUCTR)
17/12/200811/12/2007A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3bHungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
1635EUCTR2004-002163-24-GB
(EUCTR)
08/12/200817/02/2005A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1636NCT00805766
(ClinicalTrials.gov)
December 20089/12/2008Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)Crohn's DiseaseDrug: TA-650Mitsubishi Tanabe Pharma CorporationNULLCompleted16 Years75 YearsAll39Phase 3Japan
1637NCT00771667
(ClinicalTrials.gov)
December 200810/10/2008A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF TherapyA Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist TherapyCrohn's DiseaseDrug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)Centocor, Inc.NULLCompleted18 YearsN/AAll526Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom
1638NCT00774982
(ClinicalTrials.gov)
December 200816/10/2008Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease PatientsPilot, Randomized, Open-Label, Two-Way Crossover Comparative Bioavailability Study of 40 mg Delayed Release Oral 6Mercaptopurine Versus 100 mg Purinethol in Patients With Crohns DiseaseCrohns DiseaseDrug: Delayed Release 6 mercaptopurine;Drug: 6 MercaptopurineTeva GTCNULLCompleted18 Years50 YearsBoth12Phase 1Israel
1639NCT00801125
(ClinicalTrials.gov)
December 20081/12/2008Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a TherapyA Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a TherapyCrohn's DiseaseDrug: natalizumabBiogenElan PharmaceuticalsWithdrawn18 YearsN/ABoth0Phase 4NULL
1640NCT01378390
(ClinicalTrials.gov)
December 200821/6/2011Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's DiseaseRandomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's DiseaseComplex Perianal Fistula;Crohn DiseaseDrug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: PlaceboTigenix S.A.U.NULLTerminated18 YearsN/AAll56Phase 3Austria;Netherlands;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1641NCT00783692
(ClinicalTrials.gov)
December 200831/10/2008Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's DiseaseA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: vedolizumab;Other: PlaceboMillennium Pharmaceuticals, Inc.NULLCompleted18 Years80 YearsAll1116Phase 3United States;Canada;Puerto Rico
1642EUCTR2008-002100-26-SE
(EUCTR)
27/11/200808/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Denmark;Belgium;France;Sweden
1643EUCTR2007-006494-90-BE
(EUCTR)
24/11/200818/08/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
MedDRA version: 17.0;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: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
Abbvie Deutschland GmbH & Co. K.G.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Belgium;United States;Czech Republic;Canada;Poland
1644EUCTR2008-003571-45-FR
(EUCTR)
21/11/200807/08/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1645EUCTR2008-000649-77-AT
(EUCTR)
20/11/200803/11/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2bUnited Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1646EUCTR2008-002100-26-DE
(EUCTR)
19/11/200806/03/2009PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
1647EUCTR2008-003571-45-IT
(EUCTR)
18/11/200822/09/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - NDA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - ND CP-690,550 is being developed for the treatment of patients with moderate-to-severe Crohn?s disease, as defined by a baseline Crohn?s Disease Activity Index (CDAI) score of 220 to 450 inclusive.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Code: CP-690,550
Product Name: CP-690,550
Product Code: CP-690,550
PFIZERNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1648EUCTR2008-004276-49-GB
(EUCTR)
12/11/200827/01/2009A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Teva Pharmaceutical Industries Ltd.NULLNot Recruiting Female: yes
Male: yes
180Phase 2France;Belgium;Spain;Netherlands;Italy;United Kingdom
1649EUCTR2008-003571-45-BE
(EUCTR)
05/11/200814/07/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1650EUCTR2008-002100-26-DK
(EUCTR)
04/11/200818/08/2008PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACEPENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Ferring Pharmaceuticals A/SNULLNot RecruitingFemale: yes
Male: yes
510Germany;United Kingdom;Belgium;Denmark;France;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1651NCT01559142
(ClinicalTrials.gov)
November 200819/3/2012Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn DiseaseEfficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized StudyCrohn DiseaseDrug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone)Children's Memorial Health Institute, PolandNULLActive, not recruiting7 Years17 YearsBoth100Phase 3Poland
1652NCT00752622
(ClinicalTrials.gov)
November 200812/9/2008Treatment With Infliximab in a Medical Setting (Study P05587)Optimization of Treatment With Infliximab in a Medical SettingCrohn's DiseaseBiological: Infliximab 5 mg/kg;Biological: Infliximab 5 mg/kg every 6 weeks;Biological: Infliximab 7 mg/kg every 8 weeksMerck Sharp & Dohme Corp.NULLTerminated18 YearsN/AAll100Phase 4Canada
1653EUCTR2008-004926-18-DE
(EUCTR)
30/10/200830/10/2008Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMPComparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP Moderate to severe Crohn’s diseaseTrade Name: Humira
Trade Name: Remicade
IBD Center LMU MunichNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
1654EUCTR2008-003571-45-HU
(EUCTR)
29/10/200805/08/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1655EUCTR2006-003371-13-CZ
(EUCTR)
29/10/200811/05/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02.A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
709Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1656EUCTR2008-003571-45-ES
(EUCTR)
15/10/200801/08/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP-690,550 EN SUJETOS CON ENFERMEDAD DE CROHN DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP-690,550 EN SUJETOS CON ENFERMEDAD DE CROHN DE MODERADA A GRAVE Enfermedad de Crohn
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy
1657EUCTR2008-004276-49-NL
(EUCTR)
14/10/200805/08/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
199Phase 2aUnited Kingdom;Netherlands;Belgium;France;Spain;Italy
1658EUCTR2008-003571-45-SK
(EUCTR)
13/10/200823/09/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CP-690,550
Product Name: CP-690,550
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
136Phase 2France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Netherlands;Italy;United Kingdom
1659EUCTR2008-004276-49-BE
(EUCTR)
07/10/200815/09/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Spain;Belgium;Netherlands;United Kingdom;Italy
1660NCT00808262
(ClinicalTrials.gov)
October 200812/12/2008Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's DiseaseA Phase I/II, Open-label, Escalating Dose, Optimal Two-stage, Study of TNFa-Kinoid (TNF- K) Immunization in Crohn's Disease PatientsCrohn's DiseaseBiological: TNFa KinoidNeovacsNULLCompleted18 Years65 YearsBoth21Phase 1;Phase 2South Africa;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1661EUCTR2008-003167-39-BE
(EUCTR)
17/09/200828/08/2008Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn.Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn. Crohn' disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: diflucan
INN or Proposed INN: FLUCONAZOLE
Cliniques Universitaires Saint LucNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Belgium
1662EUCTR2008-004276-49-ES
(EUCTR)
16/09/200818/07/2008Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave.Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave. Enfermedad de Crohn activa de moderada a grave
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Cápsulas 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
199United Kingdom;Netherlands;Belgium;France;Spain;Italy
1663EUCTR2007-001913-41-AT
(EUCTR)
10/09/200818/06/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1664EUCTR2008-004276-49-IT
(EUCTR)
08/09/200804/08/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn?s Disease - NDA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn?s Disease - ND Crohn Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2aUnited Kingdom;Netherlands;Belgium;France;Spain;Italy
1665EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1666NCT00736983
(ClinicalTrials.gov)
September 200815/8/2008Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn'sAdalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to CiprofloxacinCrohn's Disease With Perianal FistulasDrug: adalimumab;Drug: ciprofloxacinFoundation for Liver ResearchNULLCompleted18 Years70 YearsBoth76Phase 3Netherlands
1667EUCTR2007-001913-41-DE
(EUCTR)
27/08/200820/03/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1668EUCTR2007-002716-26-AT
(EUCTR)
08/08/200818/06/2008Clinical study to assess the long term safety of certolizumab pegol, administered at weeks 0, 2 and 4 and every 4 weeks thereafter, in patients with Crohn's disease and who participated in a previous study encoded C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3bUnited States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Australia;Latvia;Germany;New Zealand
1669NCT00584740
(ClinicalTrials.gov)
August 200821/12/2007Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseDrug: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years75 YearsAll59Phase 2Germany;Canada;United States
1670EUCTR2006-004814-41-NL
(EUCTR)
24/07/200822/01/2008A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1671EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
1672EUCTR2006-004784-58-FR
(EUCTR)
07/07/200824/06/2008An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease. Crohn's diseaseTrade Name: Selective Immunosuppressive agents
Product Name: Remicade 100 mg
INN or Proposed INN: infliximab
CHRU de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25United Kingdom;Germany;Belgium;France
1673NCT00715117
(ClinicalTrials.gov)
July 200814/7/2008The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's DiseaseThe Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's DiseaseCrohn's DiseaseDrug: Naltrexone;Other: Placebo, sugar pillMilton S. Hershey Medical CenterNULLCompleted6 Years17 YearsAll14Phase 2United States
1674EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
1675EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1676EUCTR2007-000189-19-IT
(EUCTR)
10/06/200817/10/2008Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23 Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ITF 2357ITALFARMACONULLNot RecruitingFemale: yes
Male: yes
80Netherlands;Belgium;Italy
1677NCT00707512
(ClinicalTrials.gov)
June 200827/6/2008CD INFORM: Investigating Natalizumab Through Further Observational Research and MonitoringINFORM: Investigating Natalizumab Through Further Observational Research and MonitoringCrohn's DiseaseDrug: natalizumabBiogenNULLTerminated18 YearsN/ABoth87N/AUnited States;Puerto Rico
1678EUCTR2006-004784-58-DE
(EUCTR)
27/05/200811/03/2008Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIFEffect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: remicade
Product Name: remicade
INN or Proposed INN: INFLIXIMAB
University of LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25United Kingdom;Germany;Belgium;France
1679EUCTR2006-004814-41-IT
(EUCTR)
19/05/200813/03/2008A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - NDA Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND Moderate to severe Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
1680EUCTR2008-001131-35-NL
(EUCTR)
14/05/200829/05/2008Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trialAzathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 monthsTrade Name: Remicade
Product Name: Infliximab
Product Code: EU/1/99/116/003
Trade Name: Imuran
Product Name: Azathioprine
Product Code: RVG 05565
Academic Medical Center, department of Gastroenterology and hepatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1681NCT00686374
(ClinicalTrials.gov)
May 1, 200827/5/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 StudyCrohn's DiseaseBiological: AdalimumabAbbVie (prior sponsor, Abbott)NULLCompleted7 Years18 YearsAll100Phase 3Belgium;Canada;Czech Republic;Czechia;France;Netherlands;Poland;United Kingdom;United States
1682NCT00672763
(ClinicalTrials.gov)
May 20082/5/2008Adjuvant Vitamin D With Corticosteroids in Active Crohn's DiseaseThe Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's DiseaseCrohn's DiseaseDrug: Colecalciferol D3 (Vigantol Oil);Drug: Medium chain triglyceridesImperial College LondonNULLWithdrawn18 YearsN/ABoth0Phase 4United Kingdom
1683NCT01297907
(ClinicalTrials.gov)
May 200824/1/2011Bronchial Hyperreactivity in Children With Crohn DiseaseCrohn's DiseaseOther: Methacholine Challenge Test;Other: Fractional Exhaled NO (FENO);Other: Blood Test;Other: PCDAIRambam Health Care CampusNULLCompleted6 Years25 YearsBoth47N/AIsrael
1684EUCTR2008-001466-93-GB
(EUCTR)
30/04/200828/03/2008Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2 Active Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
1685EUCTR2008-001467-10-GB
(EUCTR)
30/04/200828/03/2008Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3 Ulcerative colitis - in remissionCrohn's Disease - in remission
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1686EUCTR2007-001913-41-CZ
(EUCTR)
14/04/200807/04/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3bHungary;Finland;Germany;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
1687EUCTR2007-006692-37-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
Imperial College LondonNULLNot Recruiting Female: yes
Male: yes
210Phase 4United Kingdom
1688EUCTR2007-002716-26-CZ
(EUCTR)
07/04/200807/04/2008A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3bEstonia;Hungary;Czech Republic;Finland;Belgium;Austria;Latvia;Italy
1689EUCTR2006-003371-13-IE
(EUCTR)
03/04/200805/02/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006).A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
906Phase 3France;Czech Republic;Poland;Belgium;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom
1690EUCTR2006-004814-41-CZ
(EUCTR)
12/03/200801/06/2007A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1691EUCTR2007-001913-41-IT
(EUCTR)
04/03/200812/02/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - NDA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - ND Crohn?s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelletechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1692EUCTR2007-002716-26-IT
(EUCTR)
04/03/200812/02/2008A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - NDA phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND Crohn?s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3bHungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
1693NCT01487759
(ClinicalTrials.gov)
March 20086/12/2011Prebiotic Effect on Metabolites in Crohn's DiseaseMetabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease PatientsCrohn DiseaseDietary Supplement: Oligofructose enriched inulin;Dietary Supplement: MaltodextrinKatholieke Universiteit LeuvenNULLCompleted18 YearsN/ABoth67N/ABelgium
1694NCT00552058
(ClinicalTrials.gov)
March 200818/10/2007Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's DiseasePhase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.Crohn DiseaseBiological: certolizumab pegol (CDP870, CZP);Other: PlaceboUCB PharmaNULLCompleted18 Years75 YearsAll439Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Czechia;Estonia;Finland;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Czech Republic;Spain
1695EUCTR2007-004269-16-GB
(EUCTR)
28/02/200826/03/2008Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease childrenPharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children Growth failure in children with Crohn's diseaseTrade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
Queen Mary, University of LondonNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1696EUCTR2006-003371-13-PL
(EUCTR)
27/02/200830/11/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02. Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
709Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
1697EUCTR2007-001913-41-EE
(EUCTR)
11/02/200811/12/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1698EUCTR2007-003239-21-FR
(EUCTR)
05/02/200815/01/2008A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECTA phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol (rINN)
Other descriptive name: Anti TNF humanized antibody Fab fragment-PEG conjugate
UCB PHARMA S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3bFrance
1699EUCTR2007-001913-41-BE
(EUCTR)
23/01/200813/11/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1700EUCTR2007-002716-26-BE
(EUCTR)
22/01/200816/10/2007Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bUnited States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Romania;Australia;Latvia;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1701EUCTR2006-004814-41-BE
(EUCTR)
21/01/200801/06/2007A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
1702EUCTR2007-001014-17-DE
(EUCTR)
07/01/200803/03/2008A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s diseaseA Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Rifaximin-EIRAlfa Wassermann S.p.A.NULLNot RecruitingFemale: yes
Male: yes
424Phase 2France;Hungary;Germany;Italy
1703NCT02185183
(ClinicalTrials.gov)
January 200828/4/2014Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBDCrohn's DiseaseDrug: AlequelHadassah Medical OrganizationNULLCompleted18 Years70 YearsAll22Phase 1;Phase 2NULL
1704NCT00615199
(ClinicalTrials.gov)
January 200814/1/2008A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.Crohn's DiseaseDrug: CP-690,550;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll139Phase 2United States;Belgium;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom
1705NCT00517296
(ClinicalTrials.gov)
January 200815/8/2007Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal FistulasEUS Guided Treatment With Humira for Crohn's Perianal FistulasCrohn Disease;Rectal FistulaProcedure: EUA with seton placement if necessary;Drug: adalimumab;Procedure: EUSVanderbilt University Medical CenterNULLCompleted18 YearsN/AAll21Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1706EUCTR2007-002716-26-LV
(EUCTR)
20/12/200705/11/2007A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3bCzech Republic;Estonia;Hungary;Finland;Belgium;Austria;Latvia;Italy
1707EUCTR2007-001913-41-LV
(EUCTR)
20/12/200705/11/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1708EUCTR2007-002716-26-HU
(EUCTR)
18/12/200731/10/2007Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. Crohn's disease
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]
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bAustralia;Latvia;Germany;New Zealand;United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania
1709EUCTR2007-001913-41-HU
(EUCTR)
18/12/200731/10/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bFinland;Hungary;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1710EUCTR2007-002716-26-FI
(EUCTR)
12/12/200716/10/2007A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3bHungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1711EUCTR2007-001913-41-FI
(EUCTR)
12/12/200716/10/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3bHungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
1712NCT00619489
(ClinicalTrials.gov)
December 200711/2/2008Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's DiseasePhase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: vedolizumabMillennium Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll72Phase 2Canada
1713EUCTR2005-003337-40-IT
(EUCTR)
19/11/200730/12/2008Autologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTICAutologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTIC Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Trade Name: THYMOGLOBULINE
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
WOLFSON DIGESTIVE DISEASES CENTRENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United Kingdom;Italy
1714NCT00358683
(ClinicalTrials.gov)
November 200728/7/2006A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's DiseaseOpen Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study.Crohn's DiseaseDrug: Certolizumab pegolUCB PharmaNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
1715NCT00562887
(ClinicalTrials.gov)
November 200721/11/2007Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's DiseaseA Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.Crohn's DiseaseBiological: Placebo;Biological: ABT-874AbbottNULLTerminated18 Years74 YearsBoth246Phase 2United States;Australia;Austria;Belgium;Canada;Denmark;Puerto Rico;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1716EUCTR2007-001014-17-HU
(EUCTR)
16/10/200719/06/2007A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s diseaseA Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Rifaximin-EIR
INN or Proposed INN: Rifaximin
Alfa Wassermann S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
424Phase 2Hungary;Germany;France;Italy
1717EUCTR2005-003827-38-AT
(EUCTR)
15/10/200715/10/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
1718NCT00774969
(ClinicalTrials.gov)
October 200716/10/2008Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's DiseasePhase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's DiseasePerianal Crohns'Drug: MetronidazoleS.L.A. Pharma AGNULLCompleted18 Years65 YearsBoth19Phase 1United Kingdom
1719NCT00792740
(ClinicalTrials.gov)
October 200714/11/2008Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's DiseaseMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's DiseaseCrohn's DiseaseDrug: ITF2357;Drug: Placebo capsulesItalfarmacoNULLTerminated18 Years88 YearsBoth51Phase 1;Phase 2Belgium
1720EUCTR2005-003827-38-FR
(EUCTR)
20/09/200723/07/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Bulgaria;France;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1721EUCTR2005-003827-38-SE
(EUCTR)
19/09/200711/07/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
1722EUCTR2005-003827-38-BE
(EUCTR)
19/09/200726/07/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Czech Republic;United Kingdom;Denmark;Belgium;France;Bulgaria;Austria;Sweden
1723NCT00482092
(ClinicalTrials.gov)
September 17, 200730/5/2007Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's DiseaseA Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's DiseaseCrohn's DiseaseDrug: adult human mesenchymal stem cells;Drug: PlaceboMesoblast, Inc.NULLCompleted18 Years70 YearsAll330Phase 3United States;Australia;Canada;New Zealand
1724NCT00543374
(ClinicalTrials.gov)
September 17, 200711/10/2007Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's DiseaseA Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: PROCHYMAL adult human mesenchymal stem cellsMesoblast, Inc.NULLCompleted18 Years70 YearsAll98Phase 3United States;Canada
1725NCT00528073
(ClinicalTrials.gov)
September 200710/9/2007Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's DiseaseA Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's DiseaseCrohn's DiseaseDrug: Rifaximin-EIRAlfa Wassermann S.p.A.NULLCompleted18 Years75 YearsBoth410Phase 2France;Germany;Hungary;Israel;Italy;Poland;Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1726EUCTR2007-000189-19-BE
(EUCTR)
16/08/200703/08/2007Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s DiseaseMulticenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease Moderate-to-severe active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Code: ITF2357Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
80Netherlands;Belgium;Italy
1727EUCTR2006-003371-13-GB
(EUCTR)
16/08/200722/01/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006).A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006). Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
906Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
1728EUCTR2006-004814-41-FR
(EUCTR)
07/08/200721/05/2007A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
1729EUCTR2007-000189-19-NL
(EUCTR)
06/08/200714/06/2007Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s DiseaseMulticenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease Moderate-to-severe active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Code: ITF2357Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
80Netherlands;Belgium;Italy
1730EUCTR2007-001014-17-FR
(EUCTR)
26/07/200701/06/2007A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s diseaseA Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Rifaximin-EIRAlfa Wassermann S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
424Phase 2Hungary;Germany;France;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1731EUCTR2007-001014-17-IT
(EUCTR)
26/07/200724/10/2007A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06 moderate active Crohn disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: NORMIX*AD 12CPR RIV 200MG
INN or Proposed INN: Rifaximin
ALFA WASSERMANNNULLNot RecruitingFemale: yes
Male: yes
424Phase 2Hungary;Germany;France;Italy
1732EUCTR2006-003371-13-DE
(EUCTR)
17/07/200714/12/2006A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
709Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
1733NCT00513552
(ClinicalTrials.gov)
July 20076/8/2007Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium ParatuberculosisTreatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium ParatuberculosisCrohn's DiseaseDrug: Rifabutin, Clarithromycin, and ClofazimineMedstar Health Research InstituteNULLWithdrawn18 Years90 YearsAll0Phase 4United States
1734EUCTR2006-004784-58-BE
(EUCTR)
22/06/200711/04/2007Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIFEffect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: remicade
Product Name: remicade
INN or Proposed INN: INFLIXIMAB
University of LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25United Kingdom;Germany;Belgium;France
1735JPRN-UMIN000004427
2007/06/0101/11/2010A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection Crohn's diseaseNon-infliximab arm:
Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).

Infliximab arm:
Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.
Lower GI disease, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female30Phase 2;Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1736EUCTR2006-001729-24-ES
(EUCTR)
01/06/200701/06/2007Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study.Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. Pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Patients suffering from Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1737NCT00495521
(ClinicalTrials.gov)
June 200729/6/2007High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in ChildrenA Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's DiseaseCrohn's DiseaseDrug: 4-Aminosalicylic acid extended release granulesJacobus PharmaceuticalNULLTerminated2 Years18 YearsAll2Phase 2United States;Israel
1738NCT00724529
(ClinicalTrials.gov)
June 200725/7/2008Post Marketing Surveillance of RemicadePost Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)Crohn's Disease;Ankylosing SpondylitisBiological: InfliximabJanssen Korea, Ltd., KoreaNULLCompletedN/AN/ABoth938Korea, Republic of
1739NCT00606346
(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
1740EUCTR2006-003371-13-NL
(EUCTR)
22/05/200719/01/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006)A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006) Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
906Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1741EUCTR2006-003371-13-FR
(EUCTR)
16/05/200729/12/2006A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006).A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
906Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
1742EUCTR2006-001729-24-IT
(EUCTR)
10/05/200726/06/2007Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 Patients suffering from Crohn's disease and having completed the C87042 study
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
UCB PHARMANULLNot RecruitingFemale: yes
Male: yes
600United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1743EUCTR2006-001729-24-NL
(EUCTR)
10/05/200718/04/2007Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1744EUCTR2006-001729-24-AT
(EUCTR)
09/05/200718/12/2006Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.ANULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1745EUCTR2006-001729-24-SE
(EUCTR)
25/04/200709/03/2007Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1746EUCTR2005-003977-25-DE
(EUCTR)
13/04/200705/03/2007A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSICA phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.ANULLNot RecruitingFemale: yes
Male: yes
85Phase 3Germany;Belgium
1747EUCTR2006-003371-13-BE
(EUCTR)
03/04/200724/01/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
709Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
1748EUCTR2006-003371-13-DK
(EUCTR)
03/04/200709/03/2007A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
709Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Ireland;Italy;Poland
1749NCT00307931
(ClinicalTrials.gov)
April 200724/3/2006Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed InfliximabCertolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to InfliximabCrohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLTerminated18 YearsN/AAll16Phase 3Greece
1750NCT00409682
(ClinicalTrials.gov)
April 20078/12/2006Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's DiseaseA Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: AdalimumabAbbottNULLCompleted6 Years17 YearsAll192Phase 3United States;Belgium;Canada;Czech Republic;France;Netherlands;Poland;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1751EUCTR2005-003827-38-DE
(EUCTR)
15/03/200714/12/2006A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden
1752EUCTR2005-003827-38-HU
(EUCTR)
13/03/200722/12/2006A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
423Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
1753EUCTR2006-003371-13-IT
(EUCTR)
09/03/200714/07/2008A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn?s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. - NDA Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn?s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. - ND Crohn's Disease, NOS
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: abatacept
INN or Proposed INN: abatacept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
906Phase 3Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland
1754EUCTR2005-003827-38-BG
(EUCTR)
09/03/200701/03/2007A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
336Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
1755JPRN-JapicCTI-070367
01/3/2007A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's DiseaseA Multi-Center, Randomized, Double-Blind, Placebo-controlled study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease Crohn's diseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneous
Abbott Japan Co., Ltd.Eisai Co., Ltd.1575BOTH80NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1756EUCTR2006-002078-23-GR
(EUCTR)
27/02/200710/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
1757EUCTR2006-002078-23-GB
(EUCTR)
22/02/200709/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Sweden
1758EUCTR2006-001729-24-FR
(EUCTR)
22/02/200722/01/2007Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
605United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1759EUCTR2006-001729-24-GB
(EUCTR)
14/02/200707/12/2006Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
UCB S.ANULLNot Recruiting Female: yes
Male: yes
605Phase 3France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
1760EUCTR2006-003871-11-DE
(EUCTR)
06/02/200726/10/2006An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR IIAn open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I).
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
352Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1761EUCTR2006-002078-23-PT
(EUCTR)
06/02/200701/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1762JPRN-JapicCTI-070366
01/2/2007A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's DiseaseA Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease Crohn's diseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneous
Abbott Japan Co., Ltd.Eisai Co., Ltd.1575BOTH80NULL
1763EUCTR2005-003977-25-BE
(EUCTR)
31/01/200711/12/2006A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSICA phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.ANULLNot RecruitingFemale: yes
Male: yes
85Phase 3Germany;Belgium
1764EUCTR2004-001213-34-GB
(EUCTR)
30/01/200719/08/2008Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicyl acid
Trade Name: Budenofalk
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Czech Republic;United Kingdom
1765EUCTR2006-006632-22-BE
(EUCTR)
26/01/200719/12/2006Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trialChange from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA
Trade Name: REMICADE
University of Leuven, Division of GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1766EUCTR2005-005363-28-HU
(EUCTR)
25/01/200725/09/2006A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASA DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin®, Spherical Adsorptive Carbon
Ocera Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria
1767EUCTR2006-001729-24-DE
(EUCTR)
16/01/200720/11/2006Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol in patients suffering from Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
605United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1768EUCTR2006-002078-23-FI
(EUCTR)
10/01/200731/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1769EUCTR2006-002078-23-SE
(EUCTR)
10/01/200709/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira
Product Code: ABT Humira
Product Name: Humira pre-filled PEN
Product Code: ABT Humira
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1770EUCTR2005-005363-28-AT
(EUCTR)
08/01/200710/01/2007A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASA DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin®, Spherical Adsorptive Carbon
Ocera Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1771NCT00417690
(ClinicalTrials.gov)
January 20072/1/2007High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's DiseaseA Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's DiseaseCrohn's DiseaseDrug: 4-Aminosalicylic acid;Drug: PASER placebo granulesJacobus PharmaceuticalNULLTerminated18 Years65 YearsBoth54Phase 2United States;Israel
1772NCT00354367
(ClinicalTrials.gov)
January 200718/7/2006Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining FistulasA Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.Crohn DiseaseDrug: Certolizumab pegolUCB PharmaNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
1773NCT00427921
(ClinicalTrials.gov)
January 200726/1/2007Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)Crohn's DiseaseBiological: adalimumabAbbottNULLCompleted18 YearsN/AAll304Phase 3United States
1774NCT00356408
(ClinicalTrials.gov)
January 200725/7/2006Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's DiseaseAn Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).Crohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLCompleted18 YearsN/AAll106Phase 3United States;Canada;Germany
1775EUCTR2006-002027-16-GR
(EUCTR)
12/12/200605/09/2006Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action. Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximabProduct Name: certolizumab pegol
Product Code: CDP870
UCB AENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1776EUCTR2006-002078-23-DE
(EUCTR)
07/12/200622/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: Humira pre-filled PENAbbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1777NCT00409617
(ClinicalTrials.gov)
December 20068/12/2006Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseA Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: adalimumabAbbottNULLCompleted18 Years75 YearsAll945Phase 3Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Norway;Portugal;Slovakia;Spain;Sweden;Switzerland;United Kingdom;United States
1778NCT00406653
(ClinicalTrials.gov)
December 20061/12/2006A Study of Abatacept in Patients With Active Crohn's DiseaseA Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical TherapyCrohn's DiseaseDrug: abatacept;Drug: placeboBristol-Myers SquibbNULLTerminated18 YearsN/AAll451Phase 3United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;Argentina;Ireland;Korea, Republic of;Spain;United Kingdom
1779NCT00417391
(ClinicalTrials.gov)
December 200628/12/2006Phase II Study of RR110 in Patients With Active Crohn's DiseasePhase II Study of RR110 in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: RR110 (Tamibarotene)R&R Inc.NULLCompleted20 YearsN/ABoth24Phase 2Japan
1780EUCTR2006-003870-88-DE
(EUCTR)
27/11/200629/09/2006A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR IA Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
352Phase 3bGermany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1781EUCTR2006-002078-23-FR
(EUCTR)
24/11/200629/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Product Name: Humira pre-filled PEN
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Abbott GmbH & Co. KG (Abbott)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1782EUCTR2006-002078-23-DK
(EUCTR)
24/11/200626/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1783EUCTR2005-002319-26-HU
(EUCTR)
24/11/200623/03/2006Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, pilot, four week, parallel-group, multicentre, phase II studyEfficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, pilot, four week, parallel-group, multicentre, phase II study Crohn's diseaseProduct Code: AZD9056AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Hungary;Germany;Belgium;Austria
1784EUCTR2006-002078-23-ES
(EUCTR)
23/11/200619/06/2013A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).Enfermedad de Crohn moderada a grave.
MedDRA version: 16.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856
Trade Name: Humira
Product Name: Humira pre-filled PEN
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Germany;Sweden
1785EUCTR2006-002078-23-CZ
(EUCTR)
21/11/200621/11/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1786NCT00349752
(ClinicalTrials.gov)
November 200630/6/2006Corticosteroid Sparing Effect of Certolizumab in Crohn's DiseaseA Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.Crohn's DiseaseBiological: certolizumab pegol 400 mg;Other: PlaceboUCB PharmaNULLTerminated18 YearsN/AAll174Phase 3United States;Canada;Germany;Belgium
1787EUCTR2005-005291-32-DE
(EUCTR)
24/10/200606/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
1788EUCTR2006-002078-23-NO
(EUCTR)
23/10/200622/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CAREA Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CARE Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
1789EUCTR2006-001729-24-BE
(EUCTR)
18/10/200601/09/2006Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1790EUCTR2006-002078-23-BE
(EUCTR)
16/10/200616/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1791EUCTR2006-002078-23-NL
(EUCTR)
12/10/200610/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab
Product Name: Humira pre-filled PEN
INN or Proposed INN: adalimumab
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
1792EUCTR2005-000496-17-SE
(EUCTR)
06/10/200624/02/2005Atorvastatin in moderat active Crohns diseaseAtorvastatin in moderat active Crohns disease Crohn's disease is an idiopathic chronic inflammatory bowel disease thought to result from inappropriate and ongoing activation of the mucosal immune system driven by the presence of normal luminal flora. It may affect the hole gastrointestinal tract, from mouth to rectum, with symptoms such as diarrhea, weight lose, malabsorption, abdominal pain and fever.Product Name: atorvastatinRegion SkåneNULLNot RecruitingFemale: yes
Male: yes
12Sweden
1793NCT00333788
(ClinicalTrials.gov)
October 20062/6/2006Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's DiseaseOpen Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.Crohn's DiseaseBiological: Certolizumab pegol (CDP870)UCB PharmaNULLCompleted18 YearsN/AAll233Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
1794NCT00573469
(ClinicalTrials.gov)
October 200613/12/2007Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's DiseaseA Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: D9421-C, 9mg;Drug: D9421-C, 15mg;Drug: PlaceboAstraZenecaNULLCompleted18 Years65 YearsAll75Phase 2Japan
1795NCT00454545
(ClinicalTrials.gov)
October 200629/3/2007Atorvastatin in Moderate Active Crohns DiseaseCrohns DiseaseDrug: AtorvastatinSkane University HospitalNULLCompleted18 Years65 YearsBoth12Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1796NCT00897312
(ClinicalTrials.gov)
October 20069/5/2009Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn DiseaseTitle: Evaluation of Systemic IDO Levels After Various ImmunotherapeuticsMelanomaBiological: infliximab;Biological: pegylated interferon alfa;Biological: ticilimumab;Drug: ribavirin;Other: high performance liquid chromatography;Other: laboratory biomarker analysisVanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedN/AN/ABoth7N/ANULL
1797EUCTR2006-002494-48-GB
(EUCTR)
27/09/200618/09/2006Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s diseaseSildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease Active colonic Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon)
Trade Name: ViagraUniversity College London / University College London Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
15United Kingdom
1798EUCTR2006-002078-23-AT
(EUCTR)
25/09/200604/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
1799EUCTR2005-005291-32-IT
(EUCTR)
14/09/200613/12/2006A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - NDA multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND Crohn s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Abbott GmbH Co.KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
1800NCT00353756
(ClinicalTrials.gov)
September 200617/7/2006Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn’s DiseaseA Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn’s DiseaseCrohn's DiseaseDrug: C326, IL-6 Inhibitory Avimer proteinAvidiaNULLRecruiting18 Years65 YearsBoth52Phase 1Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1801EUCTR2005-005291-32-NL
(EUCTR)
23/08/200628/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
1802EUCTR2005-005363-28-BE
(EUCTR)
22/08/200627/04/2006A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASA DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin®, Spherical Adsorptive Carbon
Ocera Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria
1803NCT00348283
(ClinicalTrials.gov)
August 200630/6/2006Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the ColonA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the ColonCrohn's DiseaseBiological: adalimumab;Biological: placeboAbbottNULLCompleted18 Years75 YearsAll135Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Sweden
1804EUCTR2005-004104-37-ES
(EUCTR)
28/07/200611/05/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3bGermany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
1805EUCTR2005-005291-32-SE
(EUCTR)
25/07/200612/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1806EUCTR2005-005291-32-BE
(EUCTR)
20/07/200603/05/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
1807EUCTR2005-005363-28-GB
(EUCTR)
11/07/200617/01/2006A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASA DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.Ocera Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom
1808NCT00287170
(ClinicalTrials.gov)
July 20062/2/2006Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's DiseasePilot, Open-Label, Randomized, Parallel Group Study to Evaluate Clinical/ and Immunological Efficacy/Safety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CDCrohn's DiseaseDrug: Delayed Release 6MP or Calcitriol vs. PurinetholTeva GTCNULLCompleted18 Years75 YearsBoth15Phase 1;Phase 2Israel
1809EUCTR2005-005291-32-AT
(EUCTR)
28/06/200628/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
1810EUCTR2005-004104-37-DK
(EUCTR)
15/06/200604/05/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3bSpain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1811EUCTR2005-004104-37-SE
(EUCTR)
08/06/200621/04/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3bGermany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
1812NCT00305409
(ClinicalTrials.gov)
June 200620/3/2006Synbiotic Treatment in Crohn's Disease PatientsSynbiotic Treatment in Crohn's Disease PatientsCrohn's DiseaseDrug: Synbiotic (Synergy I / B.longum)University of DundeeNULLCompleted18 Years79 YearsBoth50N/AUnited Kingdom
1813NCT00329537
(ClinicalTrials.gov)
June 200623/5/2006Study of Sargramostim in Moderately to Severely Active Crohn's DiseaseOpen-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)Crohn's DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth11Phase 2Japan
1814NCT00338650
(ClinicalTrials.gov)
June 200619/6/2006Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to InfliximabCrohn's DiseaseDrug: adalimumabAbbottNULLCompleted18 Years75 YearsBoth1000Phase 3United States
1815EUCTR2005-004104-37-AT
(EUCTR)
24/05/200604/04/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3bGermany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1816EUCTR2005-004104-37-DE
(EUCTR)
19/05/200629/03/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3bUnited Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden
1817EUCTR2005-004104-37-GB
(EUCTR)
17/05/200617/03/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
UCB S.A.NULLNot Recruiting Female: yes
Male: yes
600Phase 3Spain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
1818EUCTR2005-005363-28-CZ
(EUCTR)
15/05/200618/04/2006A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASA DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin®, Spherical Adsorptive Carbon
Ocera Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Hungary;Germany;United Kingdom;Czech Republic;Belgium;Austria
1819EUCTR2005-005363-28-DE
(EUCTR)
02/05/200602/06/2006A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULASA DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin®, Spherical Adsorptive Carbon
Ocera Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Hungary;Czech Republic;United Kingdom;Germany;Belgium;Austria
1820EUCTR2005-003827-38-GB
(EUCTR)
02/05/200618/11/2005A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.ChemoCentryx, IncNULLNot Recruiting Female: yes
Male: yes
598Phase 2France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1821NCT00329420
(ClinicalTrials.gov)
May 200622/5/2006Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week IntervalsCrohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLCompleted16 Years64 YearsAll46Phase 2Japan
1822NCT00317369
(ClinicalTrials.gov)
May 200621/4/2006A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's DiseaseA Dose-Finding Study of OPC-6535 in Patients With Active Crohn's DiseaseCrohn DiseaseDrug: OPC-6535(Tetomilast)Otsuka Pharmaceutical Co., Ltd.NULLTerminated16 Years65 YearsBoth60Phase 2Japan
1823NCT00329550
(ClinicalTrials.gov)
May 200622/5/2006Maintenance Study of Certolizumab Pegol (CZP) in Crohn's DiseaseA 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week IntervalsCrohn's DiseaseBiological: Certolizumab pegol (CZP)UCB Japan Co. Ltd.NULLCompleted16 Years64 YearsAll40Phase 2Japan
1824EUCTR2005-002319-26-AT
(EUCTR)
05/04/200622/02/2006Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study - POPCRONEfficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study - POPCRON Crohn's diseaseProduct Code: AZD9056AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Hungary;Germany;Belgium;Austria
1825NCT00308581
(ClinicalTrials.gov)
April 200628/3/2006Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to InfliximabPhase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to InfliximabCrohn's DiseaseBiological: Certolizumab pegol;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll539Phase 3United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1826NCT00655733
(ClinicalTrials.gov)
April 20066/4/2008Phase II Study of HMPL-004 in Subjects With Crohn's DiseaseDouble-blind, Randomized, Multicenter, Placebo-controlled Phase II Study of Efficacy and Safety of HMPL-004 in Subjects With Active Moderate Crohn's DiseaseCrohn's DiseaseDrug: HMPL-004;Drug: PlaceboHutchison Medipharma LimitedNULLCompleted18 YearsN/AAll101Phase 2United States
1827EUCTR2005-004104-37-BE
(EUCTR)
23/03/200627/01/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3bGermany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
1828NCT00294112
(ClinicalTrials.gov)
March 13, 200617/2/2006Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's DiseaseA Phase II, Open-label, Randomized Study to Evaluate the Safety and Efficacy of PROCHYMAL™ IBD (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects Experiencing Moderate-to-severe Crohn's Disease That is Refractory to Steroids and Immune SuppressantsCrohn's DiseaseDrug: Prochymal™ adult human mesenchymal stem cells;Drug: adult human mesenchymal stem cellsMesoblast, Inc.NULLCompleted18 Years70 YearsAll10Phase 2United States
1829EUCTR2005-005414-20-IT
(EUCTR)
06/03/200631/01/2006Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBDRandomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis
MedDRA version: 6.1;Level: PT;Classification code 10021972
Trade Name: Thalidomide Pharmion
INN or Proposed INN: Thalidomide
ISTITUTO PER L INFANZIA BURLO GAROFOLONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Italy
1830NCT00291668
(ClinicalTrials.gov)
March 2, 200610/2/2006Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's DiseaseA Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's DiseaseCrohn's DiseaseBiological: Certolizumab Pegol;Other: PlaceboUCB PharmaNULLCompleted16 Years65 YearsAll94Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1831NCT00306215
(ClinicalTrials.gov)
March 200621/3/2006A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's DiseaseA Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: CCX282-BChemoCentryxNULLCompleted18 YearsN/ABoth436Phase 2Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;Netherlands;Poland;South Africa;Sweden;United Kingdom
1832EUCTR2005-003827-38-DK
(EUCTR)
27/02/200607/12/2005A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
598Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden
1833EUCTR2005-003827-38-CZ
(EUCTR)
20/02/200615/12/2005A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s DiseaseA Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.Product Name: CCX282-B
Product Code: CCX282-B
ChemoCentryx, IncNULLNot RecruitingFemale: yes
Male: yes
400Hungary;United Kingdom;Czech Republic;Belgium;Denmark;France;Bulgaria;Austria;Sweden
1834EUCTR2005-003337-40-GB
(EUCTR)
13/02/200613/01/2006Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTICAutologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC Patients with Crohn's disease who have not responded to immunosupressant medicationProduct Name: Cyclophosphamide
Product Code: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
Product Name: Filgrastim
Product Code: N/A
INN or Proposed INN: Filgrastim
Other descriptive name: N/A
Product Name: rabbit antithymocyte globulin
Product Code: rbATG
INN or Proposed INN: rabbit antithymocyte globulin
Other descriptive name: N/A
Product Name: Mesna
Product Code: N/A
INN or Proposed INN: mensa
Other descriptive name: N/A
Product Name: methyl prednisolone
Product Code: N/A
INN or Proposed INN: methyl prednisolone
Other descriptive name: N/A
Product Name: ciprofloxacin
Product Code: N/A
INN or Proposed INN: ciprofloxacin
Other descriptive name: N/A
European Group for Blood and Marrow Transplantation (EMBT)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48United Kingdom
1835NCT00286689
(ClinicalTrials.gov)
February 3, 20061/2/2006Effects of Growth Hormone in Chronically Ill ChildrenHurler Syndrome;Cerebral Palsy;Juvenile Rheumatoid Arthritis;Crohn Disease;HIV InfectionsDrug: Growth Hormone;Procedure: Whole body Protein turnover;Procedure: DEXA scanUniversity of Texas Southwestern Medical CenterNULLWithdrawn3 Years17 YearsAll0N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1836NCT00297648
(ClinicalTrials.gov)
February 200627/2/2006Mucosal Healing Study in Crohn's Disease (CD)A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.Crohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLCompleted18 YearsN/AAll89Phase 3Belgium;France;Germany
1837EUCTR2005-002857-29-HU
(EUCTR)
04/01/200618/08/2005A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s DiseaseA Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s Disease Moderate to severe, active Crohn’s disease
MedDRA version: 3.2;Level: LLT;Classification code 10011401
Product Name: STA-5326 mesylate
Product Code: S38
Other descriptive name: STA-6838, STA-5326 m, S38
Synta Pharmaceutical CorporationNULLNot RecruitingFemale: yes
Male: yes
282Hungary
1838NCT00630643
(ClinicalTrials.gov)
January 200628/2/2008NI-0401 in Active Crohn's DiseaseA Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s DiseaseModerate to Severe Crohn's DiseaseBiological: NI-0401 (anti-CD3 mAB);Drug: PlaceboNovImmune SANULLCompleted18 Years70 YearsBoth40Phase 1;Phase 2NULL
1839NCT00295165
(ClinicalTrials.gov)
January 200621/2/2006Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseaseRandomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth33Phase 3United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine
1840EUCTR2005-002319-26-BE
(EUCTR)
23/12/200513/12/2005Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II studyEfficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study Crohn's diseaseProduct Code: AZD9056AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Hungary;Germany;Belgium;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1841EUCTR2005-002319-26-DE
(EUCTR)
20/12/200528/10/2005Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II studyEfficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study Crohn's diseaseProduct Code: AZD9056AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Hungary;Germany;Belgium;Austria
1842EUCTR2004-002815-10-DE
(EUCTR)
12/12/200525/04/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
1843JPRN-C000000300
2005/12/0122/12/2005Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase - Patients with Crohn's disease in active phaseZ-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Zeria Pharmaceutical Co.,LTDNULLComplete: follow-up complete16years-old64years-oldMale and Female60Phase 3Japan
1844JPRN-C000000301
2005/12/0122/12/2005Z-206 Phase III Clinical Trial-Investigation on the remission–maintaining effect in patients with Crohn's disease in remission phase- Patients with Crohn's disease in remission phaseZ-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Zeria Pharmaceutical Co.,LTD.NULLComplete: follow-up complete16years-old64years-oldMale and Female40Phase 2;Phase 3Japan
1845NCT00571337
(ClinicalTrials.gov)
December 200525/7/2007Stop Infliximab in Patients With Crohn's DiseaseProspective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping InfliximabCrohn DiseaseDrug: InfliximabGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth126Phase 3Belgium;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1846NCT00250198
(ClinicalTrials.gov)
November 3, 20055/11/2005The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's DiseaseA Randomized, Double-blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's DiseaseCrohn's DiseaseDrug: STA-5326National Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years75 YearsAll12Phase 2United States
1847NCT00838149
(ClinicalTrials.gov)
November 20055/2/2009Effect of Glutamine on Intestinal Permeability in Crohn's DiseaseEffect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled TrialCrohn's DiseaseDietary Supplement: Glutamine;Dietary Supplement: Whey proteinAll India Institute of Medical Sciences, New DelhiNULLCompleted15 Years60 YearsBoth30Phase 1India
1848EUCTR2004-004387-72-AT
(EUCTR)
11/10/200509/06/2005A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/AA Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A Crohn’s disease (CD) in patients with at least one perianal fistula.
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
18Phase 2aAustria;Germany
1849NCT00225810
(ClinicalTrials.gov)
October 200522/9/2005A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s DiseaseMulticentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s DiseaseCrohn's DiseaseDrug: Crohn's DiseaseFerring PharmaceuticalsNULLCompleted8 Years18 YearsBoth50Phase 4Czech Republic
1850EUCTR2005-002472-15-SE
(EUCTR)
22/09/200523/06/2005The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. Mild to moderate active Crohn's disease
MedDRA version: 7.1;Level: PT;Classification code 10011401
Trade Name: Pentasa Sachet 1 g prolonged release granules
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicylic acid
Ferring Laegemidler A/SNULLNot RecruitingFemale: yes
Male: yes
10Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1851NCT00132184
(ClinicalTrials.gov)
September 200518/8/2005Vitamin D Treatment for Crohn´s DiseaseRemission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell ImmunomodulationCrohns DiseaseDrug: Vitamin DUniversity of AarhusNULLActive, not recruiting18 Years90 YearsBoth110Phase 2;Phase 3Denmark
1852NCT00252369
(ClinicalTrials.gov)
September 200510/11/2005Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.Crohn's DiseaseDrug: Infliximab;Procedure: Instillation of fibrin glueSheba Medical CenterNULLTerminated18 Years90 YearsBothN/AIsrael
1853NCT00130390
(ClinicalTrials.gov)
August 200512/8/2005Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's DiseaseMulti-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in AdultsCrohn's DiseaseDrug: Nitazoxanide;Other: PlaceboRomark Laboratories L.C.NULLTerminated18 YearsN/ABoth98Phase 2United States
1854NCT00138840
(ClinicalTrials.gov)
August 200526/8/2005Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's DiseaseA Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's DiseaseCrohn's DiseaseDrug: STA-5326 mesylateSynta Pharmaceuticals Corp.NULLCompleted18 Years75 YearsBoth282Phase 2United States;Canada
1855EUCTR2004-002815-10-GB
(EUCTR)
25/07/200526/05/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Spain;Denmark;Austria;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1856EUCTR2005-002048-25-SE
(EUCTR)
20/07/200507/06/2005A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease.A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease. Inflammatory Bowel Disease (IBD) is the comprehensive term for disorders involving chronic inflammation in the gastrointestinal tract, often the small intestine and colon. It is believed to be a disorder mediated by T lymphocytes that arise in genetically susceptible persons as a result of a breakdown in the regulatory constraints on mucosal immune responses to enteric bacteria. Evidence suggests that Th1 T cells play an important pathogenetic role in Crohn´s disease.
Level: PTClassification code 10011401
Product Name: rCTB-401
Other descriptive name: rCTB-401
SBL Vaccin ABNULLNot RecruitingFemale: yes
Male: yes
25Sweden
1857EUCTR2004-002815-10-ES
(EUCTR)
18/07/200516/05/2006Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
1858EUCTR2004-002815-10-DK
(EUCTR)
07/07/200510/07/2008Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
1859NCT00167882
(ClinicalTrials.gov)
July 20059/9/2005The Influence of 5–Aminosalicylates on Thiopurine Metabolite LevelsCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseDrug: 5-aminosalicylate (Pentasa, Ferring)VU University Medical CenterNULLCompleted18 Years70 YearsBoth24Phase 4Netherlands
1860EUCTR2004-004083-77-SK
(EUCTR)
29/06/200531/01/2005A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn diseaseA Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease Moderate active Crohn diseaseTrade Name: Mesalazine EC 500 mg
Product Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Trade Name: Salofalk 500 mg
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine
Disphar International B.V.NULLNot RecruitingFemale: yes
Male: yes
436Phase 3Czech Republic;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1861EUCTR2005-001148-22-SK
(EUCTR)
27/06/200512/05/2005A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicableA 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable Crohn's disease
MedDRA version: 7.1;Level: Low;Classification code 10011401
Trade Name: Certican
Product Name: Certican
Product Code: RAD001
INN or Proposed INN: Everolimus
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: Azathioprine
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Slovakia
1862EUCTR2004-004387-72-DE
(EUCTR)
03/06/200507/01/2005A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/AA Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A Crohn’s disease (CD) in patients with at least one perianal fistula.
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
18Phase 2aGermany
1863EUCTR2004-004388-31-DE
(EUCTR)
03/06/200507/01/2005A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/AA Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD).
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
18Phase 2aGermany
1864NCT00114465
(ClinicalTrials.gov)
June 200514/6/2005VSL#3 Versus Placebo in Maintenance of Remission in Crohn's DiseaseRandomized, Double-Blind, Placebo-Controlled Study of VSL#3 Versus Placebo in the Maintenance of Remission in Crohn's DiseaseCrohn's DiseaseDrug: VSL#3;Other: PlaceboOrphan AustraliaNULLCompleted18 Years75 YearsBoth38Phase 4Australia
1865EUCTR2004-002815-10-SE
(EUCTR)
24/05/200511/04/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1866EUCTR2004-002815-10-AT
(EUCTR)
04/05/200530/03/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500Spain;Denmark;Austria;Germany;United Kingdom;Sweden
1867NCT00509639
(ClinicalTrials.gov)
May 200530/7/2007Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's DiseasePhase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease ActivityCrohn's DiseaseDrug: 10% Metronidazole OintmentS.L.A. Pharma AGNULLCompleted18 YearsN/ABoth74Phase 3United States;United Kingdom
1868NCT00829595
(ClinicalTrials.gov)
May 200523/1/2009Pneumococcal Vaccination in Patients With Inflammatory Bowel DiseasePneumococcal Vaccination in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn Disease;Ulcerative ColitisBiological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)Cedars-Sinai Medical CenterNULLCompleted18 YearsN/ABoth69N/AUnited States
1869EUCTR2004-004854-19-SK
(EUCTR)
25/04/200509/02/2005A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s diseaseA randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease Crohn's diseaseProduct Name: ITF2357
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon
Italfarmaco S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Slovakia
1870NCT00705471
(ClinicalTrials.gov)
April 200523/6/2008Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care ResourcesCrohn DiseaseBiological: InfliximabMerck Sharp & Dohme Corp.Centocor, Inc.Terminated18 YearsN/ABoth42N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1871NCT00098111
(ClinicalTrials.gov)
April 20053/12/2004Imuran (Azathioprine) Dose-Ranging Study in Crohn's DiseaseA Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS)Crohn's DiseaseDrug: azathioprineMassachusetts General HospitalNULLTerminated14 YearsN/ABoth31Phase 3United States
1872NCT00271947
(ClinicalTrials.gov)
April 20052/1/2006Crohn's Disease Stem Cell TransplantationCrohn's Disease Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard TherapyCrohn's DiseaseBiological: Autologous Stem Cell TransplantationNorthwestern UniversityNULLTerminated18 Years55 YearsAll1Phase 2United States
1873EUCTR2004-002693-37-DE
(EUCTR)
14/03/200506/01/2005A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2 Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Trade Name: UVADEX
INN or Proposed INN: methoxsalen
TherakosNULLNot RecruitingFemale: yes
Male: yes
25Germany
1874EUCTR2004-002163-24-IT
(EUCTR)
28/02/200515/06/2005A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
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: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Abbott GmBH Co KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;United Kingdom;Italy
1875EUCTR2004-002934-20-BE
(EUCTR)
22/02/200508/07/2005A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to InfliximabA Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1876EUCTR2004-002163-24-DE
(EUCTR)
09/02/200525/10/2004A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;United Kingdom;Germany;Denmark;Spain;Italy
1877EUCTR2004-003839-31-DK
(EUCTR)
05/02/200517/05/2005A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 Crohn's Disease (CD)Product Name: natalizumab
Product Code: AN100226
INN or Proposed INN: natalizumab
Elan Pharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Denmark
1878NCT00106314
(ClinicalTrials.gov)
January 200522/3/2005An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's DiseaseA Randomized, Double-Blind, Multi-Center, Dose Response, Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Moderately Active Crohn's DiseaseCrohn's DiseaseDrug: Dehydroepiandrosterone [DHEA]Inflabloc PharmaceuticalsNULLCompleted18 YearsN/ABoth75Phase 2United States;Canada
1879EUCTR2004-002163-24-SE
(EUCTR)
30/12/200412/11/2004A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
1880EUCTR2004-002163-24-ES
(EUCTR)
17/12/200407/06/2005A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1881EUCTR2004-001213-34-SK
(EUCTR)
16/12/200416/08/2005Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Phase 3Czech Republic;Slovakia;United Kingdom
1882EUCTR2004-004083-77-CZ
(EUCTR)
13/12/200402/12/2004A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn diseaseA Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease Moderate active Crohn diseaseProduct Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine
Disphar International B.V.NULLNot RecruitingFemale: yes
Male: yes
436Czech Republic
1883EUCTR2004-002693-37-AT
(EUCTR)
10/12/200405/11/2004A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - N/AA MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - N/A Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Trade Name: UVADEX
INN or Proposed INN: methoxsalen
TherakosNULLNot RecruitingFemale: yes
Male: yes
25Austria;Germany
1884NCT00206661
(ClinicalTrials.gov)
December 200412/9/2005Safety and Efficacy Study in the Treatment of Pediatric Crohn's DiseasePhase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment ExtensionCrohn DiseaseDrug: Sargramostim (Leukine)Genzyme, a Sanofi CompanyNULLTerminated6 Years16 YearsBoth22Phase 1;Phase 2United States
1885EUCTR2004-002163-24-BE
(EUCTR)
25/11/200419/08/2005A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1886EUCTR2004-002163-24-HU
(EUCTR)
23/11/200413/10/2004A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
1887EUCTR2004-002163-24-DK
(EUCTR)
16/11/200409/07/2008A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;United Kingdom;Germany;Denmark;Spain;Italy
1888EUCTR2004-001213-34-CZ
(EUCTR)
02/11/200402/11/2004Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370United Kingdom;Czech Republic
1889NCT00101946
(ClinicalTrials.gov)
October 200418/1/2005Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: 683699GlaxoSmithKlineNULLCompleted18 Years65 YearsBoth17Phase 2United States;Canada
1890NCT00105300
(ClinicalTrials.gov)
October 200411/3/2005Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to InfliximabCrohn's DiseaseDrug: AdalimumabAbbottNULLCompleted18 Years75 YearsBoth300Phase 3United States;Belgium;Canada;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1891NCT00195715
(ClinicalTrials.gov)
September 200413/9/2005Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's DiseaseA Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's DiseaseCrohn's DiseaseBiological: AdalimumabAbbottNULLCompleted18 Years75 YearsAll777Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Hungary;Italy;Netherlands;Poland;South Africa;Spain;Sweden;United Kingdom
1892NCT00300118
(ClinicalTrials.gov)
September 20047/3/2006Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease PatientsCrohn's DiseaseDrug: budesonide;Drug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth311Phase 3Germany
1893NCT00206674
(ClinicalTrials.gov)
September 200413/9/2005Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseasePhase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth286Phase 3Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom
1894NCT00102921
(ClinicalTrials.gov)
August 20044/2/2005Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn’s DiseasePilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn’s DiseaseCrohn DiseaseDrug: CCX282-BChemoCentryxNULLCompleted18 Years65 YearsBoth70Phase 2United States
1895NCT00206713
(ClinicalTrials.gov)
July 200413/9/2005Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With SargramostimPhase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to SargramostimCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth264Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1896NCT00160524
(ClinicalTrials.gov)
July 20048/9/2005A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032Crohn's DiseaseBiological: Certolizumab Pegol (CDP870)UCB Pharma SANULLCompleted18 YearsN/AAll596Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Georgia;Germany;Hong Kong;Hungary;Israel;Italy;Latvia;Lithuania;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Ukraine;Czech Republic;Tunisia
1897NCT00245947
(ClinicalTrials.gov)
April 200426/10/2005Study Evaluating ERB-041 in Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's DiseaseCrohn's DiseaseDrug: ERB-041Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth22Phase 1NULL
1898NCT00265122
(ClinicalTrials.gov)
April 200413/12/2005A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's DiseaseA Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab 90 mg;Drug: Ustekinumab 4.5 mg/kg;Drug: Placebo SC;Drug: Placebo IVCentocor, Inc.NULLCompleted18 YearsN/AAll131Phase 2United States;Belgium;Canada
1899NCT00308438
(ClinicalTrials.gov)
March 1, 200413/9/2005Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008Crohn's DiseaseDrug: Teduglutide (ALX-0600)ShireNULLCompleted18 YearsN/AAll67Phase 2United States;Canada
1900NCT00224562
(ClinicalTrials.gov)
February 200414/9/2005The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a AntagonistsThe RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a AntagonistsRheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;PsoriasisDrug: TNF-alpha antagonistsAssistance Publique - Hôpitaux de ParisNULLRecruitingN/AN/ABothN/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1901NCT00088062
(ClinicalTrials.gov)
February 200419/7/2004STA-5326 in Crohn's Disease PatientsA Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450Crohn's DiseaseDrug: STA-5326Synta Pharmaceuticals Corp.NULLCompleted18 Years65 YearsBoth48Phase 1;Phase 2United States
1902NCT00160706
(ClinicalTrials.gov)
February 20048/9/2005A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's DiseaseA Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.Crohn's DiseaseBiological: Certolizumab Pegol (CDP870)UCB Pharma SANULLCompleted18 YearsN/AAll310Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Ukraine;Czech Republic
1903NCT00152425
(ClinicalTrials.gov)
February 20047/9/2005Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870Crohn's DiseaseDrug: Certolizumab Pegol (CDP870)UCB PharmaNULLCompleted18 YearsN/ABoth392Phase 3NULL
1904NCT00152490
(ClinicalTrials.gov)
December 20038/9/2005A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: Certolizumab Pegol (CDP870)UCB PharmaNULLCompleted18 YearsN/ABoth604Phase 3NULL
1905NCT00796250
(ClinicalTrials.gov)
November 1, 200321/11/2008Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With AzathioprineCrohn's DiseaseBiological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo InfliximabMerck Sharp & Dohme Corp.NULLTerminated18 Years65 YearsAll9Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1906NCT00072839
(ClinicalTrials.gov)
October 200311/11/2003Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's DiseaseA Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's DiseaseCrohn's DiseaseDrug: ALX-0600;Drug: placebo;Drug: teduglutide 0.05;Drug: teduglutide 0.2 mg;Drug: Teduglutide 0.05 dose;Drug: teduglutide 0.1 mg doseShireNULLCompleted18 YearsN/ABoth100Phase 2United States;Canada
1907NCT00741910
(ClinicalTrials.gov)
July 200322/8/2008Extension Study of Semapimod 60 mg IV x 3 DaysExtension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: SemapimodFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth15Phase 2United States;Germany;Israel;Netherlands
1908NCT00705614
(ClinicalTrials.gov)
July 200323/6/2008Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard TherapyCrohn's DiseaseBiological: RemicadeMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll2662N/ANULL
1909NCT00077779
(ClinicalTrials.gov)
July 200312/2/2004Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseA Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: AdalimumabAbbottNULLCompleted18 Years75 YearsBoth854Phase 3United States
1910NCT00206596
(ClinicalTrials.gov)
July 200312/9/2005Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's DiseaseRandomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLCompleted18 Years80 YearsBoth127Phase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1911NCT00056355
(ClinicalTrials.gov)
March 200310/3/2003Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's DiseaseA Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohn's Disease Who May Also Be Refractory or Intolerant to Immunosuppressants and/or Anti-Tumor Necrosis Factor AgenCrohn DiseaseDrug: UVADEX and UVAR XTS Photopheresis SystemNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompletedN/AN/ABoth10Phase 1United States
1912NCT00206700
(ClinicalTrials.gov)
February 200313/9/2005Open-label Trial of Leukine in Active Crohn's DiseaseOpen-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine)Genzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth378Phase 2United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom
1913NCT00207675
(ClinicalTrials.gov)
February 200313/9/2005A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's DiseaseA Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.Crohn DiseaseDrug: infliximabCentocor, Inc.Centocor BVCompleted6 Years17 YearsBoth112Phase 3NULL
1914NCT00613197
(ClinicalTrials.gov)
January 200315/1/2008EPANOVA in Crohn's Disease, Study 1A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.Crohn's DiseaseDrug: EpanovaTillotts Pharma AGNULLCompleted18 Years70 YearsBoth384Phase 3Belgium
1915NCT00740103
(ClinicalTrials.gov)
December 200221/8/2008Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's DiseaseLong-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. PlaceboCrohn's DiseaseDrug: SemapimodFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth119Phase 2United States;Belgium;Germany;Israel;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1916NCT00739986
(ClinicalTrials.gov)
October 200220/8/2008Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus PlaceboA Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. PlaceboCrohn's DiseaseDrug: Semapimod;Drug: PlaceboFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth152Phase 2United States;Belgium;Germany;Israel;Netherlands
1917NCT00976690
(ClinicalTrials.gov)
October 200211/9/2009Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn DiseaseA Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn DiseaseCrohn DiseaseDrug: Azathioprine OR MesalazineGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth83Phase 3France
1918NCT00074542
(ClinicalTrials.gov)
September 200215/12/2003An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's DiseaseA Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: Epanova™ (Omega-3 Free Fatty Acids)Tillotts Pharma AGNULLCompleted16 YearsN/ABoth364Phase 3United States;Canada
1919NCT01070303
(ClinicalTrials.gov)
August 200216/2/2010Remission in Subjects With Crohn's Disease, Open Label ExtensionA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label ExtensionCrohn's DiseaseBiological: Adalimumab 40 mg eow or ewAbbottNULLCompleted18 Years75 YearsAll177Phase 3United States
1920NCT00055497
(ClinicalTrials.gov)
August 20023/3/2003Remission in Subjects With Crohn's Disease, 1 Year PhaseA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseBiological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mgAbbottNULLCompleted18 Years75 YearsAll276Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1921NCT00275418
(ClinicalTrials.gov)
July 200210/1/2006Beta Carotene From Natural Source for Patients With Non-Active Crohn's DiseaseDouble-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in RemissionCrohn's DiseaseDrug: beta carotene from Dunaliella algaeBnai Zion Medical CenterNULLRecruiting17 Years75 YearsBoth300Phase 3Israel
1922NCT00038766
(ClinicalTrials.gov)
June 20025/6/2002CNI-1493 for Treatment of Moderate to Severe Crohn's DiseaseA Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's DiseaseCrohn DiseaseDrug: semapimod;Drug: placeboFerring PharmaceuticalsNULLTerminated18 YearsN/ABoth33Phase 2United States
1923NCT00048295
(ClinicalTrials.gov)
May 200229/10/2002Alicaforsen (ISIS 2302) in Patients With Active Crohn’s DiseaseISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn’s DiseaseCrohn's DiseaseDrug: AlicaforsenIsis PharmaceuticalsNULLActive, not recruiting12 YearsN/ABoth150Phase 3Belgium;Czech Republic;Germany;Italy;Poland;Spain
1924NCT00055523
(ClinicalTrials.gov)
April 20024/3/2003A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseA Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: Adalimumab (D2E7)AbbottNULLCompleted18 Years75 YearsBoth300Phase 2United States
1925NCT00040521
(ClinicalTrials.gov)
April 200227/6/2002Study Evaluating rhIL-11 in Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's DiseaseCrohn Disease;Inflammatory Bowel DiseaseDrug: Recombinant Human Interleukin-11 (rhIL-11)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted16 YearsN/ABothPhase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1926NCT00446433
(ClinicalTrials.gov)
March 20027/3/2007A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's DiseaseCrohn's DiseaseDrug: CC-5013Celgene CorporationNULLCompleted12 Years75 YearsBoth90Phase 2United States;France;Israel;United Kingdom
1927NCT00032786
(ClinicalTrials.gov)
March 20023/4/2002Safety and Efficacy of Natalizumab in the Treatment of Crohn's DiseaseA Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: natalizumabBiogenElan PharmaceuticalsCompleted18 YearsN/ABothPhase 3NULL
1928NCT00072943
(ClinicalTrials.gov)
March 200212/11/2003A Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's DiseaseA Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's DiseaseCrohn's Disease;Colitis;Intestinal Disease;Gastrointestinal Disease;Digestive System DiseaseDrug: anti-Interferon-gamma monoclonal antibodyFacet BiotechNULLCompleted18 Years70 YearsBoth175Phase 2United States;Canada
1929NCT00946946
(ClinicalTrials.gov)
February 200224/7/2009Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus MesalazineDouble-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic RecurrenceCrohn's DiseaseDrug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placeboDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth78Phase 3Austria;Germany
1930NCT00035503
(ClinicalTrials.gov)
January 20023/5/2002Multicenter Trial For Patients With Acute Crohn's DiseaseCrohn's DiseaseDrug: etiprednol dicloacetateTeva Branded Pharmaceutical Products, R&D Inc.NULLCompleted18 YearsN/ABothPhase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1931NCT00304252
(ClinicalTrials.gov)
November 200114/3/2006Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's DiseaseA Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's DiseaseCrohn's DiseaseDrug: Interferon beta-1aEMD SeronoNULLTerminated18 YearsN/ABoth192Phase 2Germany;Italy;Sweden;Switzerland;United Kingdom
1932NCT00025805
(ClinicalTrials.gov)
October 23, 200125/10/2001G-CSF to Treat Crohn's DiseaseGranulocyte-Colony Stimulating Factor Treatment for Crohn's Disease: A Pilot Study Assessing Immune and Clinical ResponseCrohn's DiseaseDrug: G-CSFNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 YearsN/AAll23Phase 1United States
1933NCT02209792
(ClinicalTrials.gov)
October 20015/8/2014Dose Finding Study of BIRB 796 BS in Patients With Moderate to Severe Crohn's DiseaseA Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included.Crohn DiseaseDrug: Placebo;Drug: BIBR 796 BS, 5 mg;Drug: BIBR 796 BS, 20 mgBoehringer IngelheimNULLTerminated18 Years65 YearsBoth284Phase 2NULL
1934NCT00048113
(ClinicalTrials.gov)
September 200124/10/2002Alicaforsen (ISIS 2302) in Patients With Active Crohn's DiseaseISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: AlicaforsenIsis PharmaceuticalsNULLCompleted12 YearsN/ABoth150Phase 3United States;Canada
1935NCT00278577
(ClinicalTrials.gov)
April 200115/1/2006Hematopoietic Stem Cell Support in Patients With Severe Crohn's DiseaseImmune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's DiseaseCROHN'S DISEASEBiological: Immune Ablation and Hematopoietic Stem Cell SupportRichard Burt, MDNULLTerminatedN/A60 YearsBoth25Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1936NCT00007163
(ClinicalTrials.gov)
December 20009/12/2000Monoclonal Antibody Treatment of Crohn's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Safety Study of Two Parallel Dose Levels of Subcutaneously Administered Human Monoclonal Antibody to Interleukin-12 (J695) in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: J695National Institute of Allergy and Infectious Diseases (NIAID)NULLCompletedN/AN/ABoth40Phase 1United States
1937NCT00207662
(ClinicalTrials.gov)
July 200013/9/2005A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's DiseaseACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: infliximab or placeboCentocor, Inc.NULLCompleted18 YearsN/ABoth580Phase 3NULL
1938NCT00207766
(ClinicalTrials.gov)
June 200013/9/2005A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's DiseaseACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S DiseaseCrohn DiseaseDrug: infliximab or placeboCentocor, Inc.NULLCompleted18 YearsN/ABoth306Phase 3NULL
1939NCT00655135
(ClinicalTrials.gov)
February 20003/4/2008Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's PatientsPhase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's DiseaseCrohn's DiseaseDrug: LDP-02;Drug: PlaceboMillennium Pharmaceuticals, Inc.NULLCompleted18 Years80 YearsBoth185Phase 2NULL
1940NCT00004941
(ClinicalTrials.gov)
July 199624/2/2000Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's DiseaseCrohn's DiseaseDrug: monoclonal antibody cA2FDA Office of Orphan Products DevelopmentCentocor, Inc.Completed18 Years65 YearsBoth94Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1941NCT00269841
(ClinicalTrials.gov)
May 199622/12/2005An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's DiseaseA Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's DiseaseCrohn DiseaseDrug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: PlaceboCentocor, Inc.NULLCompleted18 Years65 YearsBoth94Phase 3NULL
1942NCT00004423
(ClinicalTrials.gov)
December 199518/10/1999Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's DiseaseCrohn's DiseaseDrug: -aminosalicylic acidUniversity of VermontNULLCompleted18 Years80 YearsBoth80N/ANULL
1943NCT00269854
(ClinicalTrials.gov)
June 199522/12/2005An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's DiseaseA Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's DiseaseCrohn DiseaseDrug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: PlaceboCentocor, Inc.NULLCompleted18 Years65 YearsBoth108Phase 2;Phase 3NULL
1944EUCTR2017-004294-14-IE
(EUCTR)
27/04/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
1945EUCTR2017-004295-55-IE
(EUCTR)
27/04/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1946EUCTR2014-004560-38-Outside-EU/EEA
(EUCTR)
12/11/2014The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease. Crohn's Disease
MedDRA version: 17.1;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: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbott Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
80Japan
1947EUCTR2016-003123-32-PL
(EUCTR)
02/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
1948EUCTR2019-004225-24-DE
(EUCTR)
17/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
1949JPRN-JapicCTI-121765
A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in JapanA Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan Crohn's DiseaseIntervention name : D9421-C
Dosage And administration of the intervention : 9mg, Oral once daily
Control intervention name : Mesalazine
Dosage And administration of the control intervention : 1g, Oral three times a day
AstraZenecaNULL15BOTHPhase 3NULL
1950EUCTR2011-000854-44-NL
(EUCTR)
06/07/2011A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat several hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but neither the doctor nor the patient will knowduring the study.A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease Crohn's disease
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]
Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170
Toray Industries IncNULLNot RecruitingFemale: yes
Male: yes
609Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1951EUCTR2018-004346-42-PL
(EUCTR)
01/08/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNAFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
1952EUCTR2019-001866-14-GB
(EUCTR)
09/04/2020Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
AstraZeneca ABNULLNAFemale: yes
Male: yes
1000Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of
1953EUCTR2016-003123-32-CZ
(EUCTR)
19/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNA Female: yes
Male: yes
855Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
1954EUCTR2019-004225-24-GB
(EUCTR)
25/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;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: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom
1955EUCTR2014-004531-39-Outside-EU/EEA
(EUCTR)
12/11/2014A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease. Crohn's Disease
MedDRA version: 17.1;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: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbott Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
80Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1956EUCTR2017-003649-10-PL
(EUCTR)
11/12/2017A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
F. Hoffmann-La Roche LtdNULLNA Female: yes
Male: yes
60Phase 1United States;Belgium;Spain;Poland;Germany;United Kingdom
1957EUCTR2016-003190-17-PL
(EUCTR)
01/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1958EUCTR2017-000574-11-CZ
(EUCTR)
01/11/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNAFemale: yes
Male: yes
2453Phase 3Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands
1959EUCTR2016-003191-50-NO
(EUCTR)
16/11/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
1960EUCTR2016-000522-18-FR
(EUCTR)
21/06/2016Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: humira
INN or Proposed INN: ADALIMUMAB
Product Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Methotrexate
Product Name: methotrexate
PIBDNetNULLNAFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1961EUCTR2017-004295-55-CZ
(EUCTR)
05/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Celgene International II SàrlNULLNA Female: yes
Male: yes
1350Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
1962EUCTR2010-022383-12-DE
(EUCTR)
02/11/2010A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s DiseaseA 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease Subjects with Crohn's Disease
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]
Product Name: GSK1605786A
Product Code: GSK1605786A
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
750Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden
1963EUCTR2012-005226-29-NL
(EUCTR)
08/03/2013Antibiotic therapy for children with active Crohn's diseaseAzithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole
Wolfson Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70United States;Canada;Israel;Netherlands
1964EUCTR2016-001956-22-FR
(EUCTR)
23/01/2017A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNAFemale: yes
Male: yes
40Phase 1United States;France;Canada;Poland;Belgium;Germany
1965EUCTR2020-003193-48-NL
(EUCTR)
21/11/2020A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease. Complex Perianal Fistulas in Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Darvadstrocel
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
20Phase 3Spain;Poland;Israel;Netherlands;Japan;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1966EUCTR2017-000574-11-PL
(EUCTR)
05/12/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA Ulcerative colitis or Crohn's 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]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNAFemale: yes
Male: yes
2453Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
1967JPRN-JapicCTI-111460
29/03/2011Phase II Study of Z-206 in Patients with Active Crohn's DiseasePhase II Study of Z-206 in Patients with Active Crohn's Disease Active Crohn's diseaseIntervention name : Z-206
INN of the intervention : Mesalazine
Dosage And administration of the intervention : oral
Zeria Pharmaceutical Co., Ltd.Kyowa Hakko Kirin Co., Ltd.1664BOTHPhase 2NULL
1968EUCTR2006-002078-23-SK
(EUCTR)
11/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's DiseaseA Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease Moderate to severe Crohn´s Disease (Harvey Bradshaw index score greater or equal to 7)Trade Name: HUMIRAAbbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
1969EUCTR2011-003743-22-DE
(EUCTR)
20/10/2011A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: budesonide
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110United States;Canada;Poland;Germany;Italy
1970EUCTR2016-003191-50-PL
(EUCTR)
03/08/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1971EUCTR2019-000333-39-FR
(EUCTR)
04/10/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
1972EUCTR2017-000617-23-PL
(EUCTR)
20/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNAFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
1973EUCTR2014-004400-30-Outside-EU/EEA
(EUCTR)
27/02/2015Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42) A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals Crohn’s Disease
MedDRA version: 17.1;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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL
UCB Japan Co., Ltd.NULLNAFemale: yes
Male: yes
46Japan
1974EUCTR2014-004399-42-Outside-EU/EEA
(EUCTR)
05/03/2015Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease Crohn’s Disease
MedDRA version: 17.1;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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL
UCB Japan Co., Ltd.NULLNAFemale: yes
Male: yes
100Phase 2Japan
1975EUCTR2017-004292-31-IE
(EUCTR)
27/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1976EUCTR2010-023589-39-HU
(EUCTR)
26/05/2011A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ST10-021
Product Code: ST10-021
Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)
Iron Therapeutics (Switzerland) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
1977EUCTR2017-004293-33-DE
(EUCTR)
06/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
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]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
1978EUCTR2006-004814-41-Outside-EU/EEA
(EUCTR)
07/02/2012A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNAFemale: yes
Male: yes
184NULL
1979EUCTR2015-002882-41-AT
(EUCTR)
05/11/2015A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s diseaseSono-­Response-­StudyA Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease Inflammatory bowel disease (Crohn's disease)
MedDRA version: 18.1;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: SonoVue
Product Name: SonoVue
INN or Proposed INN: sulphur hexafluoride
Other descriptive name: SULFUR HEXAFLUORIDE
Medical University of Vienna (MUW)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
1980EUCTR2007-006494-90-Outside-EU/EEA
(EUCTR)
07/02/2012Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
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: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
Abbott GmbH & Co. K.G.NULLNAFemale: yes
Male: yes
100Belgium;Canada;Czech Republic;Poland;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1981JPRN-JapicCTI-080566
09/04/2008A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's DiseaseA Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease Crohn's DiseaseIntervention name : Budesonide
Dosage And administration of the intervention : Oral
AstraZenecaNULL1865BOTHPhase 2NULL
1982EUCTR2014-004132-20-Outside-EU/EEA
(EUCTR)
28/07/2016Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in JapanA multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Entocort
Product Code: D9421-C
INN or Proposed INN: budesonide
Trade Name: Pentasa
INN or Proposed INN: mesalazine
AstraZeneca K.K.NULLNAFemale: yes
Male: yes
112Phase 3Japan
1983EUCTR2016-003123-32-NL
(EUCTR)
10/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
1984EUCTR2017-000617-23-CZ
(EUCTR)
25/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNAFemale: yes
Male: yes
983Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
1985EUCTR2017-000576-29-IE
(EUCTR)
10/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1986EUCTR2017-000575-88-PL
(EUCTR)
20/06/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNAFemale: yes
Male: yes
1032Phase 3United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan
1987EUCTR2019-000176-41-DE
(EUCTR)
15/08/2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment Crohn's Disease
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]
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy
1988EUCTR2015-001925-18-NO
(EUCTR)
27/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1989EUCTR2015-001924-40-PL
(EUCTR)
29/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
1990EUCTR2016-003123-32-NO
(EUCTR)
16/11/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1991EUCTR2017-002231-41-FR
(EUCTR)
15/12/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
1992EUCTR2016-000522-18-PL
(EUCTR)
04/04/2018Risk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]PIBDnet (Pediatric Inflammatory Bowel Disease Network)NULLNA Female: no
Male: no
312Phase 4France;Hungary;Czech Republic;Canada;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom
1993EUCTR2015-004121-13-Outside-EU/EEA
(EUCTR)
17/11/2015A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's DiseaseA Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 18.1;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: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie GKNULLNAFemale: yes
Male: yes
28Japan
1994EUCTR2014-004381-24-Outside-EU/EEA
(EUCTR)
02/03/2015The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) - NURTURE Crohn’s Disease
MedDRA version: 17.1;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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: Certolizumab Pegol
UCB CelltechNULLNAFemale: yes
Male: yes
100Phase 2United States;Australia;Canada;New Zealand
1995EUCTR2017-000575-88-CZ
(EUCTR)
25/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
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]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNAFemale: yes
Male: yes
1032Phase 3Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
1996EUCTR2017-000617-23-IE
(EUCTR)
10/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
1997EUCTR2010-019996-32-NL
(EUCTR)
27/07/2011A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective and safe for treating adult subjects with moderate to severe Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’ TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 Moderate to severe Crohn’s Disease
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]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Germany;Netherlands
1998EUCTR2014-004354-34-Outside-EU/EEA
(EUCTR)
27/02/2015Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals Crohn’s Disease
MedDRA version: 17.1;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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL
UCB Japan Co., Ltd.NULLNAFemale: yes
Male: yes
35Japan
1999EUCTR2010-022382-10-NO
(EUCTR)
23/11/2010A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s DiseaseA Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
600Phase 3Slovakia;Spain;Austria;United Kingdom;Italy;Czech Republic;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
2000EUCTR2011-003742-40-DE
(EUCTR)
20/10/2011A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: BUDESONIDE
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
50United States;Canada;Poland;Germany;Italy