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 96. クローン病 [臨床試験数:890,薬物数:832(DrugBank:211),標的遺伝子数:161,標的パスウェイ数:201] 

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT04151225March 3, 202011 November 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: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll280Phase 2
2NCT04118088January 1, 202022 October 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 (ASPIRE)Crohn's Disease;Complex Perianal FistulaBiological: DarvadstrocelMillennium Pharmaceuticals, Inc.Not recruiting18 YearsN/AAll50Phase 4
3NCT02677350December 1, 201915 July 2019AlloGeneic 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 HareNot recruiting18 YearsN/AAll0Phase 1United States
4NCT04134065December 1, 20194 November 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 recruiting20 Years60 YearsAll30Early Phase 1
5NCT03992469December 20194 November 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 SinaiNot recruiting18 Years30 YearsAll28Phase 1United States
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6NCT03943446November 4, 20194 November 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.Not recruiting18 YearsN/AAll75Phase 2United States;Austria;France;Germany;Netherlands;United Kingdom
7NCT03961815November 1, 201926 August 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: BrazikumabAllerganRecruiting16 Years80 YearsAll1000Phase 3United States
8NCT04073472November 1, 20199 September 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 ClinicNot recruiting18 Years75 YearsAll15Phase 1United States
9NCT04154735November 201911 November 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 UniversityNot recruiting18 Years49 YearsAll0Phase 2United States
10NCT04075825October 30, 201916 September 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.Not recruiting18 YearsN/AAll150Phase 3
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11NCT04131504October 16, 201911 November 2019Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNFCrohn's Disease;IBDDrug: Infliximab;Drug: AdalimumabChildren's Hospital Medical Center, CincinnatiThe Leona M. and Harry B. Helmsley Charitable TrustRecruiting1 Year22 YearsAll240Phase 3United States
12NCT04014517October 1, 201929 July 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 HumanitasNot recruiting18 YearsN/AAll350N/A
13NCT04112212October 1, 201914 October 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 GroningenNot recruiting18 YearsN/AAll35Phase 1
14NCT04131322October 201928 October 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 SevillaNot recruiting18 YearsN/AAll216Phase 4
15JPRN-jRCT103119005630/09/20195 November 2019E6011-CS1 studyResearch for medicinal predictive marker on Crohn's disease - E6011-CS1 studyCrohn's disease
Crohn's disease;D003424
Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.
Kousaku NankiEA Pharma Co.,Ltd.(Utilize AMED's funds)Recruiting>= 16age oldNot applicableBoth28N/Anone
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16NCT04102111September 23, 201911 November 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, LLCRecruiting18 Years75 YearsAll90Phase 2United States;Argentina;France;Germany;Italy;Poland;Russian Federation;Ukraine
17NCT03847467September 20, 201922 October 2019Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF TherapyPilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF TherapyInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisDrug: 2'-Fucosyllactose;Other: PlaceboChildren's Hospital Medical Center, CincinnatiBroad Institute;University of Cincinnati;Connecticut Children's Medical CenterRecruiting11 Years25 YearsAll216Phase 1/Phase 2United States
18ChiCTR19000260912019-09-1930 September 2019Development 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 studyCrohn's diseaseCase series:infliximab;The First Affiliated Hospital of Sun Yat-sen UniversityNot Recruiting958BothCase series:343;Retrospective studyChina
19NCT03870334September 15, 201916 September 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.Not recruiting18 Years75 YearsAll130Phase 2
20NCT03885713September 10, 20194 November 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 PrincesaRecruiting18 YearsN/AAll180Phase 4Spain
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21NCT03917303September 201926 August 2019Control Crohn Safe TrialControl Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study.Crohn Disease;Inflammatory Bowel DiseasesDrug: Adalimumab;Drug: standard step-up careMaastricht University Medical CenterNot recruiting18 Years70 YearsAll158Phase 4
22NCT03962998September 20197 October 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-102MediBeaconRecruiting18 YearsN/AAll20Early Phase 1United States
23NCT03945019August 201929 July 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 SCCelltrionRecruiting18 Years75 YearsAll600Phase 3United States
24NCT03999580August 201915 July 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 PrevostNot recruiting4 Years18 YearsAll316Phase 3Canada
25NCT03926130July 23, 201911 November 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 CompanyRecruiting18 Years80 YearsAll1100Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom
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26NCT04018599July 15, 201930 September 2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesRecruiting18 Years55 YearsAll216Phase 1United States
27ChiCTR19000236962019-07-0111 June 2019Endoscopic 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 trialChron's diseaseGroup 1:EBD;Group 2:EBD combined with local injection of betamethasone;The Sixth Affiliated Hospital of Sun Yat-sen UniversityNot Recruiting1875BothGroup 1:45;Group 2:45;N/AChina
28JPRN-JapicCTI-19483001/7/201922 July 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 LimitedNot RecruitingBOTH300NAJapan
29NCT03905109July 1, 201923 April 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.Not recruiting18 Years75 YearsAll30Phase 2Belgium
30NCT03935451July 1, 201913 May 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 UniversityNot recruiting18 YearsN/AAll180Early Phase 1
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31NCT04002180July 1, 201929 July 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)TakedaRecruitingN/AN/AAll300Phase 3Japan
32NCT03950336July 201927 May 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 AlbertaNot recruiting15 Years50 YearsAll32N/A
33NCT04089514June 30, 201928 October 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: AdalimumabBiogenRecruiting18 YearsN/AAll1400N/AGermany;United Kingdom
34NCT03656627June 27, 201922 October 2019Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbRecruiting18 YearsN/AAll72Phase 1United States
35NCT03850509June 4, 20194 March 2019Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active InflammationEfficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentCrohn's DiseaseDrug: OPS-2071 150 mg;Drug: OPS-2071 300 mg;Drug: OPS-2071 600 mg;Drug: Matching PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.IQVIANot recruiting18 Years70 YearsAll240Phase 2
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36NCT03941418June 1, 201911 June 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 recruiting18 Years80 YearsAll150N/A
37NCT03915262June 201923 April 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 LyonNot recruiting18 YearsN/AAll50N/AFrance
38NCT03798691May 28, 201915 July 2019Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With VedolizumabA Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With VedolizumabInflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Herpes ZosterBiological: ShingrixUniversity of Wisconsin, MadisonBoston Medical CenterRecruiting50 Years70 YearsAll30Phase 4United States
39NCT03747718May 1, 201925 February 2019Randomized 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: PlaceboChildren's Mercy Hospital Kansas CityNot recruiting2 Years25 YearsAll30Phase 1United States
40NCT03808103May 1, 201913 May 2019Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's DiseaseA Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD)Crohn DiseaseBiological: Placebo;Biological: Bacteriophage preparationIntralytix, Inc.MOUNT SINAI HOSPITALRecruiting18 YearsN/AAll30Phase 1/Phase 2United States
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41NCT03733314April 25, 201922 July 2019A 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.Recruiting18 Years64 YearsAll40Phase 2Japan;Poland
42NCT03942120April 8, 201911 November 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., KoreaRecruiting18 YearsN/AAll70Phase 3Korea, Republic of
43NCT03816345April 4, 201911 November 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)Recruiting18 YearsN/AAll264Phase 1United States
44NCT03712826April 201925 March 2019Identification 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 LyonRecruiting18 YearsN/AAll60N/AFrance
45NCT03914261April 201923 April 2019Expanded Access to RisankizumabExpanded Access to RisankizumabCrohn's DiseaseDrug: RisankizumabAbbVieNot recruiting18 YearsN/AAllN/A
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46NCT03884439March 18, 20194 November 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]PfizerRecruitingN/AN/AAll300Phase 3Japan
47NCT03706456March 6, 201911 November 2019Phase 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: DarvadstrocelTakedaRecruiting18 YearsN/AAll20Phase 3Japan
48NCT03901937March 1, 201915 April 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 HospitalRecruiting18 Years75 YearsAll158Phase 4China
49EUCTR2017-000574-11-GR26/02/201928 February 2019Research 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) - AIDAUlcerative 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Shire Human Genetic Therapies, Inc.Authorised 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
50NCT03681067February 20, 201915 April 2019A 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 DiseaseCrohn DiseaseDrug: GSK1070806;Drug: Placebo- sodium chlorideUniversity of BirminghamGlaxoSmithKline;University Hospital BirminghamRecruiting16 YearsN/AAll30Phase 1/Phase 2United Kingdom
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PhaseCountries
51NCT03681652February 11, 201925 February 2019Post-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, IsraelRecruiting6 Years18 YearsAll100N/AIsrael
52NCT03718182February 11, 20195 November 2018Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled TrialCrohn Disease;Vitamin D DeficiencyDietary Supplement: CholecalciferolUniversity Hospital Birmingham NHS Foundation TrustNational Institute for Health Research, United Kingdom;University of Birmingham;Clinical Trials Research CentreNot recruiting18 YearsN/AAll50Phase 4
53NCT03627091February 6, 201911 November 2019Efficacy and Safety Study of SHP647 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: SHP647;Other: PlaceboShireRecruiting16 Years80 YearsAll983Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Bosnia and Herzegovina
54NCT03752970February 5, 201928 October 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 DiseaseCrohn DiseaseDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimRecruiting18 Years75 YearsAll28Phase 2Austria;Belgium;Germany;Hungary
55NCT03650413January 14, 201911 November 2019An 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.Recruiting18 Years80 YearsAll320Phase 2United States;Bulgaria;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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PhaseCountries
56EUCTR2018-002629-51-NL08/01/201928 February 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International N.V.Authorised Female: yes
Male: yes
200Phase 3France;United States;Spain;Germany;Netherlands;Sweden
57NCT03773237December 31, 201821 January 2019Intralipid 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 ClinicRecruiting18 Years75 YearsAll100N/AUnited States
58EUCTR2018-002925-47-ES28/12/201828 February 2019prediction 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 approachesInflammatory bowel disease
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Adalimumab
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Infliximab
Pharmaceutical Form: Infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 5-
Trade Name: Golimumab
Pharmaceutical Form: Injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Ustekinumab
Pharmaceutical Form: Injection
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Trade Name: Vedolizumab
Pharmaceutical Form: Infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaAuthorised Female: yes
Male: yes
180Phase 4Spain
59NCT03677648December 28, 201814 October 2019A 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: Placebos;Drug: SHR0302Reistone Biopharma Company LimitedRecruiting18 Years75 YearsAll144Phase 2United States;China;Poland;Ukraine
60JPRN-jRCT105119004320/12/201810 September 2019Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707Crohn's diseaseAt the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Tetsuo TakeharaHideki IijimaRecruiting20ageNot applicableBoth15Phase 2none
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03782376December 20, 201811 November 2019A 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.Recruiting18 YearsN/AAll200Phase 3United States;Austria;France;Germany;Italy;Netherlands;Spain;Sweden
62ChiCTR18000199582018-12-1618 December 2018Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's DiseaseCombining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's DiseaseCrohn's diseaseCase series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;Daping Hospital, Army Medical University (Third Military Medical University)Recruiting1865BothCase series:60;New Treatment Measure Clinical StudyChina
63EUCTR2018-002629-51-ES12/12/201828 February 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International N.V.Authorised Female: yes
Male: yes
200Phase 3France;United States;Spain;Netherlands;Germany;Sweden
64NCT03759288December 7, 201826 August 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 DiseaseCrohn's Disease;IBDDrug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira®;Drug: PlaceboAllerganRecruiting16 Years80 YearsAll1140Phase 2/Phase 3United States
65NCT03574948December 6, 201811 June 20195-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, GhentRecruiting18 Years60 YearsAll180Phase 2Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
66EUCTR2018-001272-37-DE04/12/20187 January 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 DiseaseModerately-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
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Product Name: TD-1473
Product Code: TD-1473
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not Assigned
Current Sponsor code: TD-1473
Other descriptive name: THRX-139060
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Theravance Biopharma Ireland LimitedAuthorisedFemale: 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
67NCT02834754December 1, 201818 December 2018Vedolizumab Post Op StudyA Randomized, Double-blind, Placebo Controlled Study of Vedolizumab for the Prevention of Post-operative Crohn's Disease RecurrenceCrohn's DiseaseDrug: Vedolizumab;Drug: placeboMarc SchwartzTakedaRecruiting18 YearsN/AAll24Phase 2United States
68NCT03378167December 1, 201830 September 2019PediCRaFT: Pediatric Crohn's Disease Fecal Transplant TrialPediCRaFT: Pediatric Crohn's Disease Fecal Microbiota Transplant Pilot StudyCrohn Disease;Pediatric Crohns Disease;Inflammatory Bowel Diseases;ColitisBiological: MICROBIOTA;Biological: PLACEBOMcMaster Children's HospitalHamilton Health Sciences Corporation;McMaster UniversityRecruiting3 Years17 YearsAll45Phase 1Canada
69NCT03944447December 1, 20187 October 2019Outcomes Mandate National Integration With Cannabis as MedicineOutcomes Mandate National Integration With Cannabis as MedicineChronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar DisorderDrug: Cannabis, MedicalOMNI Medical Services, LLCRecruiting7 YearsN/AAll100000Phase 2United States
70EUCTR2017-003090-34-BE28/11/20187 January 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 CDFistulizing 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
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
SCS Boehringer Ingelheim Comm.VAuthorisedFemale: yes
Male: yes
28Phase 2Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
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PhaseCountries
71NCT03729674November 26, 20183 December 2018Comparative Effectiveness and Safety of Biosimilar and Legacy DrugsComparative Effectiveness and Safety of Biosimilar and Legacy DrugsRheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's DiseaseDrug: Biosimilar;Drug: Originator (legacy) drugMcGill University Health CenterUniversité de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research GroupNot recruiting18 YearsN/AAll800Phase 3
72NCT03635112November 19, 201830 September 2019Efficacy 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 BiopharmaRecruiting18 YearsN/AAll160Phase 2United States;Austria;Bulgaria;Croatia;France;Georgia;Germany;Greece;Hungary;Israel;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom
73EUCTR2017-005151-83-DE26/10/20186 November 2018Treatment of Crohn's disease with Ustekinumab in clinical practiceINDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUSCrohn's 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Trade Name: STELARA
Product Name: Stelara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Charité Universitätsmedizin BerlinAuthorisedFemale: yes
Male: yes
100Phase 4Germany
74NCT03833596October 25, 201825 February 2019Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD)Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential MechanismsCrohn's DiseaseDietary Supplement: Exclusive Enteral Nutrition;Drug: PrednisoneMcMaster UniversityNestléRecruiting18 Years75 YearsAll100Phase 4Canada
75NCT03723447October 23, 201811 November 2019Intraoperative 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 CenterNot recruiting18 Years90 YearsAll100Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
Inclusion_
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gender
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size
PhaseCountries
76EUCTR2017-000617-23-BE08/10/201828 February 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 Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307Crohn'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.Authorised 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;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan
77NCT03606499September 26, 201822 July 2019Real-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.Recruiting18 YearsN/AAll125Phase 2France
78JPRN-JapicCTI-18395020/9/201816 July 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, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseCrohn'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.Recruiting18BOTH2000Phase 2-3Japan, North America
79EUCTR2017-000617-23-NL17/09/20181 October 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 307Crohn'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.AuthorisedFemale: 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
80EUCTR2017-001976-48-HU13/09/20184 December 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 DiseaseCrohn'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
Pharmaceutical Form: Capsule
INN or Proposed INN: BMS-986165
CAS Number: 1609392-28-0
Other descriptive name: BMS986165
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Bristol-Myers Squibb international CorporationAuthorisedFemale: yes
Male: yes
144Phase 2United States;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT03623932September 1, 201820 August 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, GrenobleNot recruiting18 Years65 YearsAll40N/A
82NCT03615378August 30, 201826 August 2019Maintenance 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 CenterNot recruiting18 YearsN/AAll10Early Phase 1United States
83EUCTR2017-004294-14-DE23/08/201828 February 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene International II SàrlAuthorised 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
84NCT03467958August 22, 20184 November 2019An 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: OzanimodCelgeneRecruiting12 Years75 YearsAll1040Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;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
85NCT03546868August 14, 20183 September 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 FoundationRecruiting19 Years79 YearsAll20Phase 2Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03492944August 6, 201820 August 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, CincinnatiRecruiting10 Years18 YearsAll25Phase 1United States
87NCT03196427July 30, 201815 July 2019Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaRecruiting2 Years17 YearsAll80Phase 2United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
88EUCTR2017-000576-29-HU24/07/201819 November 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 306Crohn’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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.AuthorisedFemale: 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
89NCT03449069July 23, 201826 August 2019Pediatric 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 ClinicRecruiting12 Years17 YearsAll5Phase 1United States
90EUCTR2017-001737-85-NL17/07/201820 August 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 UPCrohn'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
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
academic medical centreAuthorisedFemale: yes
Male: yes
110Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03476317July 12, 201830 September 2019Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseAn Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseCrohn DiseaseDrug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: FluconazoleChildren's Hospital of PhiladelphiaUniversity of Pennsylvania;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting6 Years18 YearsAll30Phase 2United States
92EUCTR2017-000575-88-AT06/07/201826 November 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 Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305Crohn's 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.AuthorisedFemale: 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;Japan
93EUCTR2017-000617-23-AT06/07/201826 November 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 307Crohn'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.AuthorisedFemale: yes
Male: yes
983Phase 3Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Serbia;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
94NCT03860571July 6, 201811 March 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.Not recruiting18 Years65 YearsAll70Phase 1United States
95EUCTR2017-002195-13-DE03/07/20187 January 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 - GALAXIModerately 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
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: GUSELKUMAB
Current Sponsor code: CNTO 1959
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Intravenous use
Product Name: guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Guselkumab
Current Sponsor code: CNTO 1959
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Intravenous use
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Janssen-Cilag International NVAuthorisedFemale: 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03662919July 2, 201817 September 2018One-year Persistence to Treatment of Participants Receiving Flixabi: a French Cohort StudyPERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi®: a French Cohort StudyArthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, UlcerativeDrug: InfliximabBiogenRecruiting6 YearsN/AAll1500N/AFrance
97NCT03467620July 201811 June 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 ChicagoNot recruiting18 YearsN/AAll36Phase 2/Phase 3
98NCT03472690June 25, 201823 July 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.Recruiting18 YearsN/AAll170Phase 2Canada
99NCT03559517June 25, 201811 November 2019Efficacy and Safety Study of SHP647 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: SHP647;Other: PlaceboShireRecruiting16 Years80 YearsAll1032Phase 3United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom
100NCT03559660June 25, 201828 October 2019CUP 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.Not recruiting18 YearsN/AAllPhase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT03599622June 25, 20184 November 2019An 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 SquibbRecruiting18 Years75 YearsAll240Phase 2United States;Australia;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom
102EUCTR2017-000617-23-LT15/06/201823 July 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 307Crohn'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.AuthorisedFemale: 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
103NCT03566823June 11, 201811 November 2019Efficacy and Safety Study of SHP647 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: SHP647;Other: PlaceboShireRecruiting16 Years80 YearsAll1032Phase 3United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Mexico;New Zealand;Portugal;Slovakia;Spain;Ukraine
104NCT03142321June 8, 201815 July 2019Defining 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 MedicineRecruiting18 YearsN/AAll80Phase 4United States
105NCT03477032June 1, 201811 June 2019FMT in Inflammatory Bowel DiseaseFaecal Transplantation in Inflammatory Bowel DiseaseFaecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic ColitisBiological: Faecal Microbiota TransplantationSt Vincent's Hospital MelbourneRecruiting18 Years65 YearsAll50Phase 2Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2017-004292-31-LV21/05/201830 April 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene International II SàrlAuthorised 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
107EUCTR2017-004295-55-LV21/05/201830 April 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Celgene International II SàrlAuthorised 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
108ChiCTR18000151742018-05-0119 March 2018Effects 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 diseaseCrohn's diseasecontrol group:placebo;Vitamin D:800IU Vitamin D;Gudangdong General Hospital, Guangdong Academy of Medical SciencesNot Recruiting1875Bothcontrol group:32;Vitamin D:32;New Treatment Measure Clinical StudyChina
109EUCTR2017-003649-10-DE30/04/201828 February 2019A 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 DISEASEModerate 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 Level: PT 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETROLIZUMAB
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261/F02-01
Other descriptive name: ETROLIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes
60Phase 1United States;Poland;Belgium;Spain;Germany;United Kingdom
110EUCTR2017-000574-11-DE10/04/20187 January 2019Research 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) - AIDAUlcerative 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Shire Human Genetic Therapies, Inc.AuthorisedFemale: 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03105102April 9, 20184 November 2019A 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 M15-989Crohn's DiseaseDrug: placebo for risankizumab SC;Drug: risankizumab IV;Drug: placebo for risankizumab IV;Drug: risankizumab SCAbbVieRecruiting18 Years80 YearsAll912Phase 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;Hungary;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;Turkey
112EUCTR2016-004112-35-SE04/04/201830 April 2018A 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) studyPatients 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
Pharmaceutical Form: Tablet
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
Pharmaceutical Form: Tablet
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)AuthorisedFemale: yes
Male: yes
120Phase 4Sweden
113JPRN-UMIN0000318392018/04/0123 April 2019Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patientsCrohn's diseaseAt the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Osaka University Graduate School of Medicine Department of Gastroenterology and HepatologyJapan Community Health care Organizationi Osaka Hospital, Gastroenterology and Hepatology National Hospital Organization Osaka National Hospital, Gastroenterology and Hepatology Osaka Rosai Hospital , Gastroenterology and Hepatology Kansai Rosai Hospital, Gastroenterology and Hepatology Itami City Hospital, Gastroenterology and Hepatology Hyogo Prefectural Nishinomiya Hospital, Gastroenterology and HepatologyRecruiting20years-oldNot applicableMale and Female15Not selectedJapan
114NCT03452501April 201811 June 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 Including Crohn's Disease, Fistulizing Crohn's Disease and Ulcerative ColitisDrug: InfliximabHikma Pharmaceuticals LLCNot recruiting18 YearsN/AAll150Phase 3Saudi Arabia
115NCT03464136March 29, 201811 November 2019Safety 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, LLCRecruiting18 YearsN/AAll350Phase 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_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03478956March 27, 201828 October 2019A 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 RocheNot recruiting4 Years17 YearsAll24Phase 1United States;Belgium;Germany;Poland;Spain;United Kingdom
117NCT03345823March 21, 201825 March 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 M14-433Crohn's DiseaseDrug: Placebo for Upadacitinib;Drug: UpadacitinibAbbVieRecruiting18 Years75 YearsAll738Phase 3United States;American Samoa;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;Belarus
118NCT03597971March 20, 201820 August 2018HMPL004-6599 Phase I Dose-escalating StudyA Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male VolunteersUlcerative Colitis;Crohn DiseaseDrug: HMPL004-6599;Drug: PlaceboNutrition Science Partners LimitedHutchison Medipharma Limited;NestléRecruiting18 Years45 YearsMale56Phase 1Australia
119NCT03854305March 20, 20186 May 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.Not recruiting18 Years75 YearsAll93Phase 2Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
120EUCTR2017-004294-14-SK16/03/20187 January 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene International II SàrlAuthorisedFemale: 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_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2017-004295-55-SK16/03/20187 January 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Celgene International II SàrlAuthorisedFemale: 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
122EUCTR2017-000574-11-IE13/03/201823 July 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) - AIDAUlcerative 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Shire Human Genetic Therapies, Inc.AuthorisedFemale: 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
123EUCTR2017-004294-14-LT12/03/201830 April 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene International II SàrlAuthorised 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
124EUCTR2017-004295-55-LT12/03/201830 April 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Celgene International II SàrlAuthorised 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
125NCT03440385March 7, 20184 November 2019Induction 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: PlaceboCelgeneRecruiting12 Years75 YearsAll675Phase 3United States;Australia;Austria;Brazil;Bulgaria;Canada;China;Finland;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03709628March 7, 201826 November 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)EnteromeRecruiting18 YearsN/AAll8Phase 1Austria;France;Germany;Italy
127EUCTR2017-004293-33-HU06/03/201830 April 2019Multicenter 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 DiseaseModerately 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)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene International II SàrlAuthorised 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
128NCT03329209March 5, 201810 September 2018A 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: VedolizumabTakedaNot recruiting18 Years45 YearsAll16Phase 1China
129JPRN-UMIN0000308842018/02/272 April 2019A 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 GastroenterologyRecruiting18years-old75years-oldMale and Female80Not selectedJapan
130NCT03221166February 27, 201822 July 2019Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic FactorsThalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research NetworkCrohn DiseaseDrug: Thalidomide;Drug: InfliximabIRCCS Burlo GarofoloCentro di Riferimento Oncologico - Aviano;Azienda Ospedaliera Spedali Civili di BresciaRecruiting6 Years17 YearsAll124Phase 3Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT03440372February 27, 201822 October 2019Induction 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: PlaceboCelgeneRecruiting12 Years75 YearsAll675Phase 3United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;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
132NCT03801928February 23, 201821 January 2019Observational, 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: InflectraPfizerRecruiting18 YearsN/AAll300Phase 2United States
133NCT03351647February 14, 20185 March 2018Predictive 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 LyonRecruiting18 Years18 YearsAll50N/AFrance
134EUCTR2017-003017-25-AT06/02/20187 January 2019Clinical 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 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT 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)
Pharmaceutical Form: Capsule, hard
CAS Number: 1142364-35-9
Current Sponsor code: PRV-6527 (JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Provention Bio, Inc.AuthorisedFemale: yes
Male: yes
90Phase 2Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany
135EUCTR2017-002258-36-BE05/02/20184 December 2018Phase 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]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaximin-EIR
Other descriptive name: RIFAXIMINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1600-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
ALFASIGMA S.P.A.AuthorisedFemale: yes
Male: yes
180Phase 2Spain;Belgium;Netherlands;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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PhaseCountries
136NCT03358706February 2, 201811 November 2019A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Moderate to Severe Crohn's DiseaseA 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 Moderate to Severe Crohn's Disease.Crohn DiseaseDrug: 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, LLCRecruiting18 Years75 YearsAll51Phase 1United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark
137NCT03395184February 2, 20184 November 2019Study 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-06700841PfizerRecruiting18 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
138NCT03185000February 201816 December 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 recruiting18 Years80 YearsAll24Phase 1/Phase 2
139NCT03901235January 15, 201815 April 2019MSC Intratissular Injection in Crohn Disease PatientsTreatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem CellsEfficacy and SafetyBiological: Mesenchymal Stromal CellsUniversity Hospital of LiegeLaboratoire de Thérapie Cellulaire et Génétique from CHU de LiègeRecruiting18 YearsN/AAll60Phase 1/Phase 2Belgium
140EUCTR2017-002231-41-BE10/01/201820 August 2018A 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) - HubbleUlcerative 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Takeda Development Centre Europe, Ltd.AuthorisedFemale: yes
Male: yes
80Phase 2United Kingdom;Germany;Netherlands;Israel;Ukraine;Belgium;Poland;Canada;Hungary;United States;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2017-003017-25-HU08/01/201822 January 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 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 100000004856
MedDRA version: 20.1 Level: LLT 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)
Pharmaceutical Form: Capsule, hard
CAS Number: 1142364-35-9
Current Sponsor code: PRV-6527(JNJ-40346527)
Other descriptive name: JNJ-40346527-AAC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Provention Bio, Inc.AuthorisedFemale: yes
Male: yes
90Phase 2Germany;Russian Federation;Austria;Ukraine;Spain;Poland;Hungary
142EUCTR2016-003179-23-DE19/12/201728 February 2019This 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Gilead Sciences, Inc.Authorised Female: yes
Male: yes
100Phase 2United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
143NCT03104413December 18, 201722 October 2019A Study to Assess the Efficacy and Safety of Risankizumab in Subjects 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: risankizumab SC;Drug: placebo for risankizumab IV;Drug: risankizumab IVAbbVieRecruiting16 Years80 YearsAll579Phase 3United States;American Samoa;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hungary;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;Brazil;Turkey
144NCT03345849December 7, 20174 November 2019A Study of the Efficacy and Safety of Upadacitnib (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 TherapiesCrohn's DiseaseDrug: Upadacitinib;Drug: Placebo for UpadacitinibAbbVieRecruiting18 Years75 YearsAll501Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;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;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus
145EUCTR2017-002258-36-ES04/12/201726 March 2018Phase 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: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaximin-EIR
Other descriptive name: RIFAXIMINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1600-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
ALFASIGMA S.P.A.Not RecruitingFemale: yes
Male: yes
180Phase 2Spain;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT03362736December 4, 201722 October 2019An 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, LLCNot recruiting18 YearsN/AAllPhase 1Brazil
147NCT02974322December 1, 201716 December 2017A 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: PlaceboCelgeneNot recruiting12 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
148NCT02559713November 29, 201711 March 2019Postmarketing 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 DiseaseDrug: VedolizumabTakedaNot recruiting18 YearsN/AFemale11Phase 4United States
149NCT03345836November 29, 201711 November 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 TherapyCrohn's DiseaseOther: Matching placebo for upadacitinib;Drug: upadacitinibAbbVieRecruiting18 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
150EUCTR2017-002258-36-DE21/11/201728 February 2019Phase 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]
Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin-EIR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaximin-EIR
Other descriptive name: RIFAXIMINA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
ALFASIGMA S.P.A.AuthorisedFemale: yes
Male: yes
180Phase 2Spain;Belgium;Netherlands;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
151NCT03537157November 16, 201724 September 2018A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence PreventionA 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 RecurrenceCrohn DiseaseDrug: Rifaximin delayed release tablets;Other: PlaceboAlfasigma S.p.A.CromsourceRecruiting18 Years75 YearsAll156Phase 2Italy
152NCT03266484November 13, 201718 March 2019Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel DiseaseEffect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical TrialInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisDietary Supplement: Probiotic Mixture;Dietary Supplement: PlaceboMassachusetts General HospitalWinclove Bio Industries BVRecruiting18 Years75 YearsAll100N/AUnited States
153NCT03357471November 3, 201710 September 2018Study 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.Not recruiting18 YearsN/AAll70Phase 3United States
154NCT03755583November 1, 201721 January 2019Effect 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 UniversityRecruiting1 Year17 YearsAll40N/AChina
155NCT03167437October 30, 20178 April 2019Safety 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)Recruiting18 Years65 YearsAll35Phase 1/Phase 2United States
No.TrialIDDate_
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Last_Refreshed_
on
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PhaseCountries
156NCT03495973October 25, 201722 October 2019Prospective 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.Not recruiting18 YearsN/AAll110Phase 2Sweden
157NCT03171246October 23, 201711 June 2018CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's DiseaseAn Open Label Pilot Study of the CD-TREAT Diet as a Novel Therapy for Active Luminal Crohn's DiseaseCrohn DiseaseDietary Supplement: Solid food-based interventionNHS Greater Glasgow and ClydeUniversity of GlasgowRecruiting6 Years65 YearsAll20N/AUnited Kingdom
158NCT03220243October 19, 201726 August 2019Stem 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 ClinicNot recruiting18 Years65 YearsFemale5Phase 1United States
159NCT03220841October 9, 201716 September 2019Stricture Definition and Treatment (STRIDENT) Drug Therapy StudyStricture Definition and Treatment (STRIDENT) Drug Therapy StudyCrohn Disease;Inflammatory Bowel Diseases;Stricture; BowelDrug: Adalimumab Injection;Drug: Thiopurine;Procedure: Endoscopic balloon dilatationSt Vincent's Hospital MelbourneAustralasian Gastro Intestinal Research Foundation;AbbVieRecruiting18 YearsN/AAll78Phase 4Australia
160NCT03279081September 15, 20177 October 2019Study 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.Recruiting18 YearsN/AAll600Phase 3United States;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;United Kingdom
No.TrialIDDate_
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Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
161EUCTR2016-003191-50-CZ13/09/201728 February 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 M15-989Crohn'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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
CAS Number: 1612838-76-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
CAS Number: 1612838-76-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
CAS Number: 1612838-76-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
CAS Number: 1612838-76-2
Concentration unit: mg milligram(s)
Concentration type: equal
AbbVie Deutschland GmbH & Co. KGAuthorised 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;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
162JPRN-JapicCTI-18415201/9/201716 July 2019Investigation 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 diseaseCrohn's diseaseIntervention name : Budesonide ( Zentacort Capsules 3mg )
INN of the intervention : Budesonide
Dosage And administration of the intervention : Oral
ZERIA Pharmaceutical Co., Ltd.RecruitingBOTH200NA
163EUCTR2017-000725-12-CZ08/08/201723 July 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]
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: nap
Current Sponsor code: Allogenic eASCs
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Concentration unit: Other
Concentration type: equal
Concentration number: 5000000-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intralesional use
TiGenix, S.A.U.AuthorisedFemale: yes
Male: yes
326Phase 3Italy;Israel;Spain;Belgium;Poland;Canada;Czech Republic;Hungary;United States;France
164NCT03234907August 3, 201711 June 2019Vedolizumab 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: PlaceboTakedaNot recruiting18 Years80 YearsAll215Phase 3China
165NCT03162432August 1, 201730 September 2019High 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 HospitalRecruiting7 Years25 YearsAll50Phase 3United States
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166NCT03185624July 25, 201716 December 2017Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's DiseaseEffectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled TrialCrohn DiseaseDrug: RifaximinSixth Affiliated Hospital, Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw HospitalNot recruiting18 Years65 YearsAll80Phase 3China
167NCT02330211July 17, 201721 January 2019Fecal 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. KahnNot recruiting5 Years30 YearsAll4Phase 1/Phase 2United States
168NCT03169894July 14, 201718 March 2019Evaluation 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 MedicineRecruiting18 Years65 YearsAll8Phase 1United States
169NCT03219359July 12, 201723 April 2019Autologous Stem Cell Transplant for Crohn's DiseaseMaintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD)Crohn DiseaseDrug: Vedolizumab;Drug: Methylprednisolone;Drug: Thymoglobulin;Drug: Cyclophosphamide;Procedure: Autologous stem cell transplantIcahn School of Medicine at Mount SinaiRecruiting18 YearsN/AAll50Phase 2United States
170JPRN-UMIN0000281392017/07/042 April 2019Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's diseaseCrohn's diseaseTreatment with UstekinumabGraduate School of Medical Sciences, Kyushu UniversityRecruiting20years-oldNot applicableMale and Female50Not selectedJapan
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171NCT03014219July 201716 December 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.Not recruiting12 Years17 YearsAll0Phase 1United States
172NCT03235180June 16, 201714 October 2019Ultrasound 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 ClinicRecruiting18 YearsN/AAll100Phase 4United States
173NCT03267238June 16, 20174 November 2019Fecal Microbial Transplantation in Patients With Crohn's DiseaseFecal Microbial Transplantation in Patients With Crohn's DiseaseCrohn DiseaseBiological: Fecal Microbial TransplantationStony Brook UniversityNot recruiting7 YearsN/AAll9Early Phase 1United States
174NCT02764762June 12, 201711 November 2019Triple 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: MethotrexateTakedaRecruiting18 Years65 YearsAll60Phase 4United States;Canada
175NCT03393247June 1, 201718 January 2018The 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 UniversityRecruiting14 Years60 YearsAll160N/AChina
No.TrialIDDate_
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176JPRN-UMIN0000259612017/05/2110 September 2019The 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 diseaseCrohn's diseaseOral treatment of Alfacalcidol 1 microgram/day for 3 monthNagoya University HospitalRecruiting18years-oldNot applicableMale and Female31Not selectedJapan
177JPRN-jRCTs04118012621/05/201710 September 2019CD Alfacalcidol studyThe study of effect of Alfacalcidol treatment on Crohn's diseaseCrohn's diseaseadministration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level.Masanao NakamuraRecruiting18ageNot applicableBoth36Phase 2none
178NCT03155945May 18, 201716 September 2019Tolerability, 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 PharmaceuticalsNot recruiting18 Years80 YearsAll14Phase 2United States
179NCT03185611May 18, 201716 December 2017Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's DiseaseEffectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled TrialCrohn DiseaseDrug: Rifaximin;Drug: AzathioprineSixth Affiliated Hospital, Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw HospitalRecruiting18 Years65 YearsAll120Phase 3China
180NCT03105128May 10, 20174 November 2019A 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 DiseaseCrohn's DiseaseDrug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SCAbbVieRecruiting16 Years80 YearsAll940Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hong Kong;Hungary;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;Turkey
No.TrialIDDate_
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181NCT03172377May 3, 201724 September 2018Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease PatientsLengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease PatientsCrohn Disease in Remission;Crohn DiseaseOther: Lengthening adalimumab dosing intervalRadboud UniversityErasmus Medical CenterRecruiting18 YearsN/AAll174Phase 4Netherlands
182NCT03059849May 1, 201716 December 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 UniversityNot recruiting18 Years80 YearsAll290Phase 4
183NCT02994836April 21, 201727 May 2019GIS-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 ColitisDrug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus);Biological: Anti-TNF: Infliximab (Infusion)Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaRecruiting18 YearsN/AAll194Phase 4Spain
184NCT03107793April 19, 201711 November 2019Study 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.Not recruiting18 YearsN/AAll500Phase 3Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Portugal;Slovakia;Spain;Sweden;United Kingdom
185NCT03108326April 15, 201723 July 2018Real 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 GmbHRecruiting18 Years80 YearsAll900Phase 1Germany
No.TrialIDDate_
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186NCT02953275April 13, 201722 July 2019Synergistic Effect of Vedolizumab and PentoxifyllineSynergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel DiseaseCrohn DiseaseDrug: vedolizumab;Drug: Pentoxifylline;Drug: placeboUniversity of MiamiTakedaNot recruiting18 Years80 YearsAll37Early Phase 1United States
187NCT03046056April 11, 201711 November 2019Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)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 DiseaseDrug: Filgotinib;Drug: Placebo to match filgotinibGilead SciencesGalapagos NVRecruiting18 Years75 YearsAll100Phase 2United States;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Spain;Ukraine;United Kingdom
188NCT03077412April 6, 201714 October 2019Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's DiseaseA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's DiseaseFistulizing Crohn's DiseaseDrug: Filgotinib;Drug: Placebo to match filgotinibGilead SciencesGalapagos NVRecruiting18 Years75 YearsAll75Phase 2United States;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Spain;United Kingdom;Poland
189EUCTR2016-002939-15-DE05/04/201730 April 2019A 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
Pharmaceutical Form: Capsule
INN or Proposed INN: not applied for
Current Sponsor code: V565
Other descriptive name: V565
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 185-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
VHsquared LtdNot Recruiting Female: yes
Male: yes
126Phase 2United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway
190NCT03078803March 28, 201725 February 2019Fecal Transplant for Crohn's DiseaseA Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's DiseaseCrohn DiseaseBiological: Fecal Microbiota Transplant (FMT);Biological: PlaceboUniversity of AlbertaUniversity of Calgary;McMaster UniversityRecruiting18 YearsN/AAll126Phase 2Canada
No.TrialIDDate_
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191NCT03090139March 28, 20172 July 2018Sub-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 TherapyTakedaNot recruiting18 YearsN/AAll1731Phase 3Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey
192NCT03009396March 18, 201711 March 2019Open 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 LimitedNot recruiting18 Years76 YearsAll331Phase 3United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia
193NCT02914600March 17, 201722 October 2019Filgotinib in Long-Term Extension Study of Adults With Crohn's DiseaseA Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: Filgotinib;Drug: PlaceboGilead SciencesGalapagos NVRecruiting18 YearsN/AAll1000Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic
194NCT03027193March 15, 201711 November 2019A 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 OxfordRecruiting18 Years50 YearsAll28Phase 1United Kingdom
195EUCTR2016-002918-43-GB28/02/201726 February 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 UstekinumabModerately 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 130-
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Janssen-Cilag International N.V.AuthorisedFemale: yes
Male: yes
650Phase 3United Kingdom;Germany;Netherlands;Spain;Belgium;Portugal
No.TrialIDDate_
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196JPRN-UMIN0000263302017/02/2710 September 2019Efficacy 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 patientsCrohn 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 ToyamaNot Recruiting20years-oldNot applicableMale and Female30Not selectedJapan
197EUCTR2016-003797-40-BE23/02/201723 October 2017A 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 ManifestationsActive Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: APD334
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
CAS Number: 1206123 97 8
Current Sponsor code: APD334
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Arena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Germany
198EUCTR2015-001924-40-AT21/02/20176 November 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 DiseaseActive 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: mongersen
CAS Number: 1443994-98-6
Current Sponsor code: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Mongersen
Product Code: GED-0301
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: mongersen
CAS Number: 1443994-98-6
Current Sponsor code: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Austria;Turkey;Finland;Bosnia and Herzegovina;Korea, Republic of;Latvia;Netherlands;Denmark;Australia;Malaysia;France;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;United States;Portugal
199EUCTR2016-003797-40-DE21/02/201715 October 2018A 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 ManifestationsActive Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: APD334
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
CAS Number: 1206123 97 8
Current Sponsor code: APD334
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Arena Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Germany
200JPRN-UMIN0000258462017/02/012 April 2019A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseulcerative 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 medicine Department of gastroenterologyRecruiting16years-oldNot applicableMale and Female60Not selectedJapan
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201JPRN-jRCTs03118041501/02/201722 July 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 diseaseInflammatory 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.
Dai IshikawaRecruiting>=6 age oldBoth120N/Anone
202EUCTR2015-001179-36-CZ30/01/201728 February 2019Study 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-104-01Moderately 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: RHB-104
Pharmaceutical Form: Capsule
INN or Proposed INN: Clarithromycin
CAS Number: 81103-11-9
Other descriptive name: CLARITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 95-
INN or Proposed INN: Rifabutin
CAS Number: 72559-06-9
Other descriptive name: RIFABUTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
INN or Proposed INN: Clofazimine
CAS Number: 2030-63-9
Other descriptive name: CLOFAZIMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
RedHill Biopharma Ltd.Not Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
203EUCTR2016-002939-15-CZ24/01/20173 September 2018A 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
Pharmaceutical Form: Capsule
INN or Proposed INN: not applied for
Current Sponsor code: V565
Other descriptive name: V565
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 185-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
VHsquared LtdAuthorisedFemale: yes
Male: yes
126Phase 2United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom
204NCT03000101January 19, 201721 January 2019Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel DiseaseNew Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)Crohn's Disease;Ulcerative ColitisOther: placebo beverage;Other: 100% pomegranate juiceAzienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola MalpighiUniversity of Bologna;Conserve Italia;GAT FoodsNot recruiting18 Years80 YearsAll18N/AItaly
205EUCTR2016-003321-42-NL18/01/201710 April 2017Stepwise 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
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Radboud University Medical CentreAuthorisedFemale: yes
Male: yes
Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
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PhaseCountries
206NCT02968108January 18, 201727 May 2019A 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, LLCNot recruiting2 Years17 YearsAll45Phase 1United States;Belgium;Canada;France;Germany;Poland
207NCT03261102January 17, 201725 March 2019TDM Guided Early Optimization of ADAL in Crohn's DiseaseTherapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label StudyCrohn Disease;Drug Monitoring;Inflammatory Bowel DiseasesBiological: Adalimumabwaqqas.afifAbbVieRecruiting18 YearsN/AAll200N/ACanada
208EUCTR2015-001179-36-SK13/01/201728 February 2019Study 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-104-01Moderately 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: RHB-104
Pharmaceutical Form: Capsule
INN or Proposed INN: Clarithromycin
CAS Number: 81103-11-9
Other descriptive name: CLARITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 95-
INN or Proposed INN: Rifabutin
CAS Number: 72559-06-9
Other descriptive name: RIFABUTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
INN or Proposed INN: Clofazimine
CAS Number: 2030-63-9
Other descriptive name: CLOFAZIMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
RedHill Biopharma Ltd.Not Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
209EUCTR2016-002763-34-GB04/01/201728 February 2019A 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 DiseaseModerately 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Filgotinib
Product Code: GS-6034
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Gilead Sciences, Inc.Authorised 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
210NCT02862132January 201728 January 2019Predicting 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 CenterRecruitingN/A18 YearsAll120N/AUnited States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT03012542January 201711 June 2018Diet 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 WashingtonRecruiting18 YearsN/AAll32N/AUnited States
212NCT03056664January 201716 December 2017The 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 UniversityNot recruiting18 Years65 YearsAll3Phase 2/Phase 3
213EUCTR2017-000576-29-IE18 June 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 306Crohn’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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.Not AvailableFemale: yes
Male: yes
1032Phase 3Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
214EUCTR2017-000617-23-IE18 June 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 307Crohn'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: SHP647
Product Code: SHP647
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-MAdCAM antibody
Current Sponsor code: SHP647
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Shire Human Genetic Therapies, Inc.Not AvailableFemale: 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
215EUCTR2017-003649-10-PL28 February 2019A 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 DISEASEModerate 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 Level: PT 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETROLIZUMAB
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261/F02-01
Other descriptive name: ETROLIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
F. Hoffmann-La Roche LtdNot Available Female: yes
Male: yes
60Phase 1United States;Belgium;Spain;Poland;Germany;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
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PhaseCountries
216NCT02891226December 14, 20169 September 2019A 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 CompanyNot recruiting18 Years75 YearsAll180Phase 2United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France
217NCT02231814December 201624 September 2018Pilot 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 LevineRecruiting18 Years55 YearsAll40N/AIsrael
218NCT02704624December 20169 July 2018Effects of Supplementation of Vitamin D in Patients With Crohn`s DiseaseThe Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled TrialCrohn Disease;Vitamin D Deficiency;Fatigue;Sarcopenia;Muscle Weakness;Disorder of Bone Density and Structure, UnspecifiedDietary Supplement: Vitamin D;Other: PlaceboFederal University of Juiz de ForaFundação de Amparo à Pesquisa do estado de Minas GeraisRecruiting18 Years50 YearsAll110Phase 4Brazil
219NCT03183661November 16, 201616 December 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.Recruiting18 Years65 YearsAll9N/A
220EUCTR2016-000634-21-DE08/11/20163 September 2018A 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 DiseaseActive Crohn's 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
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: JNJ-64304500
Current Sponsor code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International NVAuthorisedFemale: 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_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
221JPRN-UMIN0000245662016/11/012 April 2019Study 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 HospitalNot Recruiting16years-oldNot applicableMale and Female60Not applicableJapan
222NCT02760615November 1, 201610 December 2018Phase 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: VedolizumabTakedaRecruiting18 Years55 YearsAll60Phase 4United States
223NCT02998827November 20169 January 2017Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD PatientsCrohn DiseaseDrug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutritionSixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingN/AN/AFemale90N/A
224JPRN-UMIN0000237352016/10/3123 April 2019Does 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 studyCrohn's diseaseEW or EOW injection of adalimumabSaitama Medical Center, Saitama Medical UniversityNot Recruiting15years-old75years-oldMale and Female10Not selectedJapan
225NCT02914561October 31, 201622 October 2019Filgotinib in the Induction and Maintenance of Remission in Adults 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 DiseaseCrohn's DiseaseDrug: Filgotinib;Drug: Placebo to match filgotinibGilead SciencesGalapagos NVRecruiting18 Years75 YearsAll1320Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sri Lanka;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
226EUCTR2016-002061-54-IT13/10/20167 January 2019Switch 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 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT 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
Pharmaceutical Form: Powder for solution for infusion
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINot RecruitingFemale: yes
Male: yes
250Phase 4Italy
227NCT02772965October 201628 October 2019Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) TherapyA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF TherapyPediatric Crohn's DiseaseDrug: Methotrexate;Other: Sugar pill (placebo)University of North Carolina, Chapel HillPatient-Centered Outcomes Research Institute;ImproveCareNow (ICN);The Leona M. and Harry B. Helmsley Charitable Trust;Children's Hospital Medical Center, Cincinnati;Grifols Diagnostics Solutions, Inc;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingN/A20 YearsAll425Phase 3United States
228NCT02956538October 201614 November 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 UniversityRecruiting18 Years50 YearsBoth72Phase 0China
229EUCTR2016-003073-18-GB29/09/20163 April 2017A 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 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ozanimod hydrochloride
CAS Number: 1618636-37-5
Current Sponsor code: RPC1063HCL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.1-
Celgene International II SàrlAuthorisedFemale: no
Male: yes
6Phase 1United Kingdom
230NCT02871635September 28, 201627 May 2019BI 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 IngelheimNot recruiting18 Years80 YearsAll147Phase 3United States;Belarus;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Israel;Poland;Russian Federation;Serbia;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
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Last_Refreshed_
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231EUCTR2014-004904-31-BE21/09/201620 August 2018A 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)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Mundipharma Pharmaceuticals B.V.Not RecruitingFemale: yes
Male: yes
156Phase 4Belgium;Netherlands
232NCT02883452September 12, 201626 August 2019A Phase I Study to Evaluate PK, Efficacy and Safety of CT-P13 SC in Patients With Active CD and UCAn 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 ColitisBiological: InfliximabCelltrionNot recruiting18 Years75 YearsAll170Phase 1Korea, Republic of
233JPRN-UMIN0000238712016/09/012 April 2019Comparison 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 HospitalRecruiting16years-oldNot applicableMale and Female100Not applicableJapan
234NCT02820493September 201611 June 2018Effectiveness 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 GenovaNot recruiting18 Years80 YearsAll0Phase 4
235NCT02630966August 10, 20163 December 2018Vedolizumab 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 DiseaseDrug: Vedolizumab;Drug: PlaceboTakedaNot recruiting18 Years80 YearsAll34Phase 4United States;Canada;France;Italy;Netherlands;Spain;United Kingdom;Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
236NCT02743806August 1, 201611 November 2019Extended 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: VedolizumabTakedaNot 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
237NCT02765256August 201626 August 2019Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseFundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseCrohn's DiseaseDrug: Fluconazole;Drug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: PromethazineUniversity of PennsylvaniaChildren's Hospital of Philadelphia;Crohn's and Colitis FoundationNot recruiting18 Years75 YearsAll30Phase 2United States
238NCT02897661August 201616 December 2017Fecal Microbiota Transplantation Improves Nutritional State of Patients With Crohn's DiseaseFecal Microbiota Transplantation Combined Enteral Nutrition Therapy Contribute to Nutritional Improvement of Patients With Crohns' DiseaseCrohn's DiseasesProcedure: FMT;Drug: Metronidazole;Dietary Supplement: ENThe Second Hospital of Nanjing Medical UniversityRecruiting18 Years65 YearsAll60Phase 2/Phase 3China
239NCT02641392July 25, 201611 February 2019A 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: PlaceboCelgeneNot recruiting12 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
240EUCTR2016-000205-36-DE11/07/201614 November 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) - FUTUREInflammatory 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 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: FE 999301
Pharmaceutical Form: Concentrate for solution for infusion
University Hospital Schleswig-Holstein (UKSH)AuthorisedFemale: yes
Male: yes
Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
241EUCTR2016-001638-84-NL08/07/201623 October 2017Thiopurines with Low Dose Allopurinol: a prospective one way cross-over studyThiopurines with Low Dose Allopurinol: a prospective one way cross-over study - ThiLDA-studyCrohn's disease & Colitis Ulcerosa;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Allopurinol Sandoz 100 mg, tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Current Sponsor code: allopurinol
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Current Sponsor code: allopurinol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Meander Medical CenterNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
242JPRN-UMIN0000199582016/07/022 April 2019Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatmentsCrohn's disease, ulcerative colitisPatients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
Iwate Medical University Kochi Medical School Hospital Keio University School of MedicineNot Recruiting15years-oldNot applicableMale and Female100Not applicableJapan
243NCT02768532July 1, 201626 August 2019Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's DiseaseVEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's DiseaseCrohn DiseaseDrug: VedolizumabCentre Hospitalier Universitaire de Saint EtienneTheradiag;TakedaRecruiting18 YearsN/AAll93Phase 4France
244NCT02793778July 201615 July 2019Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF TherapyA Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF TherapyCrohn's DiseaseDrug: CROWN;Drug: CROWN PlaceboPrometheus LaboratoriesNestlé Health Science Spain;Nestec Ltd.Not recruiting18 Years85 YearsAll42Phase 2United States
245NCT02806206July 20168 August 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 ColumbiaNot recruiting19 YearsN/ABoth122Phase 4Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
246JPRN-UMIN0000222702016/06/3023 April 2019Evaluation 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 studyCrohn's diseasedouble dose of adalimumabSaitama Medical CenterNot Recruiting15years-old80years-oldMale and Female20Not selectedJapan
247EUCTR2016-000678-40-CZ27/06/201628 February 2019Program 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 DiseaseUlcerative 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 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: vedolizumab IV
Product Code: MLN002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Takeda Development Centre Europe LimitedAuthorised 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
248EUCTR2015-000555-24-NL16/06/20168 August 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) - REPREVIOCrohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Concentrate and solvent for solution for infusion
Route of administration of the placebo: Intravenous use
Academic Medical Center AmsterdamAuthorisedFemale: yes
Male: yes
80Phase 4Netherlands
249EUCTR2016-001278-13-FI08/06/201627 June 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 - PROSIBDUlcerative 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 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10057035 Term: Crohn's ileocolitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10011405 Term: Crohn's enteritis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10011406 Term: Crohn's ileitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10076318 Term: Crohn's disease relapse System Organ Class: 10017947 - Gastrointestinal disorders
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 10011402 Term: Crohn's disease (colon) System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10075466 Term: Fistulising Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0 Level: LLT 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Taina SipponenAuthorisedFemale: yes
Male: yes
Phase 4Finland
250NCT02782663May 18, 20161 April 2019A Study to Evaluate 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 DiseaseCrohn's Disease (CD)Drug: ABT-494AbbVieNot recruiting18 Years75 YearsAll107Phase 2United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Romania;Slovakia;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
251ChiCTR-OPC-160086552016-05-0118 April 2017Efficacy 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 ChinaCrohn‘s Disease1:Thalidomide 75-100mg qd;2:Thalidomide 150-200mg qd;3:Thalidomide 75-100mg qd+MTX 20-25mg /W;Peking Union Medical College HospitalRecruiting1670Both1:90;2:90;3:90;Post-marketChina
252NCT02538341May 201615 April 2019Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's DiseaseBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityNot recruiting50 YearsN/AAll617Phase 2United States
253EUCTR2015-004618-10-BE19/04/20168 August 2016PhArmaCo-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 ColitisPatients 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
CAS Number: 170277-31-3
Other descriptive name: Remsima
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remicade
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Trade Name: Inflectra
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Inflectra
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
CUB- Hopital ErasmeAuthorisedFemale: yes
Male: yes
Phase 4Belgium
254NCT02620046April 15, 201620 May 2019Vedolizumab 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 SCTakedaRecruiting18 Years80 YearsAll692Phase 3Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;United States;Colombia;Czech Republic;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
255EUCTR2015-001963-37-SK14/04/201619 November 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 diseaseActive 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: mongersen
CAS Number: 1443994-98-6
Current Sponsor code: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot 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_
enrollement
Last_Refreshed_
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PhaseCountries
256NCT02749630April 11, 201611 November 2019A 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.Not recruiting18 Years80 YearsAll90Phase 1Germany;United Kingdom;Canada
257NCT02685683April 4, 201620 August 2018Pharmacodynamic 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-0301CelgeneNot recruiting18 YearsN/AAll18Phase 2Italy
258JPRN-UMIN0000200292016/04/0122 July 2019The 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 ReactivationCollagen 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.Saitama Medical UniversityRecruiting16years-oldNot applicableMale and Female300Not selectedJapan
259NCT02324699April 20163 September 2018Corticosteroids With Vedolizumab in Crohn's DiseaseCorticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized TrialCrohn's DiseaseDrug: Prednisone;Drug: Placebo;Drug: VedolizumabIcahn School of Medicine at Mount SinaiTakedaNot recruiting18 Years70 YearsAll1Phase 4United States
260NCT02538354March 201613 June 2016The Effect of Riboflavin in Crohn's DiseaseThe Effect of Riboflavin Supplementation on Faecalibacterium Prausnitzii in Crohn's DiseaseCrohn DiseaseDietary Supplement: Riboflavin supplementationUniversity Medical Center GroningenRecruiting18 Years65 YearsBoth84N/ANetherlands
No.TrialIDDate_
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261NCT02769494March 201623 May 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 DiseasesRecruiting18 Years65 YearsBoth40Phase 3China
262EUCTR2015-001925-18-GB24/02/20162 October 2017A 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 oActive 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: mongersen
CAS Number: 1443994-98-6
Current Sponsor code: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Celgene CorporationAuthorisedFemale: 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
263EUCTR2015-001963-37-LV18/02/201629 January 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 diseaseActive 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: mongersen
CAS Number: 1443994-98-6
Current Sponsor code: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Celgene CorporationNot 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
264NCT02186275February 201616 December 2017The Vitamin D in Pediatric Crohn's DiseaseRandomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of RelapsesCrohn's DiseaseDrug: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day;Drug: Vitamin D3 800 UI/day then 800 UI/daySt. Justine's HospitalCanadian Institutes of Health Research (CIHR)Recruiting9 Years18 YearsAll316Phase 3Canada
265EUCTR2015-002025-19-PL28/01/201628 February 2019An 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 DiseaseModerately 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 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856
MedDRA version: 20.0 Level: LLT 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
CAS Number: 1306760-87-1
Other descriptive name: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Product Name: 1mg RPC1063
Product Code: RPC1063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ozanimod
CAS Number: 1306760-87-1
Other descriptive name: RPC1063
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene CorporationAuthorised Female: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine
No.TrialIDDate_
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PhaseCountries
266NCT02925351January 25, 201611 November 2019Fluorine 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 CenterNational Cancer Institute (NCI)Not recruiting18 YearsN/AAll8N/AUnited States
267NCT02742597January 12, 20168 January 2018Patient-Centred Innovations for Persons With Multimorbidity - OntarioPatient-Centred Innovations for Persons With Multimorbidity - OntarioHypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;MultimorbidityBehavioral: TIP / IMPACT Plus Care CoordinationLawson Health Research InstituteWestern University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College HospitalNot recruiting18 Years80 YearsAll1980N/ACanada
268NCT02574637January 5, 201620 August 2018Evaluation of Efficacy and Safety of MEDI2070 in Subjects 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: MEDI2070 High dose;Drug: MEDI2070 High-Med dose;Drug: MEDI2070 Low-Med dose;Drug: MEDI2070 Low dose;Drug: PlaceboAllerganNot recruiting18 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
269NCT02611817January 4, 20161 July 2019Efficacy 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 TherapyCrohn's DiseaseDrug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mgTakedaNot recruiting18 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
270ChiCTR-IIR-160077512016-01-0118 April 2017Clinical 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 diseaseCrohn'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 MeridianRecruiting1670BothAcupuncture Group:40;Placebo acupuncture group:40;Drug Group:40;Phase 1 studyChina
No.TrialIDDate_
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PhaseCountries
271ChiCTR18000203052016-01-0114 January 2019A 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 ATIcrohn's disease;K50.900Group 2:infliximab + azathioprine;Group 1:infliximab alone;Department of Gastroenterology, Nanfang Hospital, Southern Medical UniversityRecruiting1280BothGroup 2:41;Group 1:45;Retrospective studyChina
272NCT02465944January 20165 September 2016A 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 PharmaceuticalsRecruiting18 Years75 YearsBoth24Phase 1/Phase 2Belgium;Netherlands
273NCT02532738January 20167 September 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 recruiting18 Years65 YearsBoth3Phase 2/Phase 3
274NCT02680756January 201618 June 2018Safety 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 TherapeuticsRecruiting18 YearsN/AAll242Phase 3United States;Belgium;France;Germany;Hungary;Spain
275EUCTR2016-000522-18-FR2 October 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 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-TRIALCrohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: humira
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Product Name: Imurel
Pharmaceutical Form: Coated tablet
INN or Proposed INN: azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 2.5-
Trade Name: Methotrexate
Product Name: methotrexate
Pharmaceutical Form: Solution for injection
PIBDNetNot AvailableFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
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PhaseCountries
276EUCTR2016-000786-24-IT5 March 2018Efficacy 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 PediatricsCrohn'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]
Trade Name: THALIDOMIDE CELGENE - 50 MG CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PE/ACLAR/ALU) 28 CAPSULE
Pharmaceutical Form: Capsule, hard
Product Name: INFLIXIMAB
Pharmaceutical Form: Powder for infusion
IRCCS Burlo GarofoloNot AvailableFemale: yes
Male: yes
124Phase 3Italy
277EUCTR2016-003190-17-CZ28 February 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 TreatmentCrohn'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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
CAS Number: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
AbbVie Deutschland GmbH & Co. KGNot Available 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;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
278NCT02596893December 8, 20152 September 2019Efficacy 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: PlaceboCelgeneNot recruiting18 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
279NCT02678052December 1, 201526 August 2019OTIS Vedolizumab Pregnancy Exposure RegistryOrganization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure RegistryColitis, Ulcerative;Crohn's DiseaseDrug: Vedolizumab;Biological: Other Biological AgentTakedaRecruiting18 Years44 YearsFemale200N/AUnited States;Canada
280NCT02620007December 20154 March 2019Evaluation 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 ParisRecruiting18 Years80 YearsAll62Phase 2France
No.TrialIDDate_
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PhaseCountries
281NCT02636517December 201518 December 2018Fecal Microbiome TransplantFecal Microbiome Transplant in Pediatric C. DifficileClostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisBiological: Fecal Microbiota TransplantChildren's Hospital of PhiladelphiaRecruiting3 Years21 YearsAll50N/AUnited States
282NCT02597829November 201517 November 2015Does Clinical Response Correlate With Serum Certolizumab Levels?Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO)Crohn's DiseaseDrug: Certolizumab PegolShafran Gastroenterology CenterUCB Pharma;UCB PharmaNot recruiting18 Years70 YearsBoth20Phase 4United States
283NCT02622763November 201525 February 2019Intralesional 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 BiomédicaRecruiting18 Years65 YearsAll20Phase 1Spain
284NCT02926300November 201516 December 2017Long-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.Recruiting19 Years70 YearsAll24N/AKorea, Republic of
285EUCTR2014-005666-29-GB16/10/201521 August 2017A 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 diseaseCrohn'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]
Product Name: Thetanix
Product Code: B. theta
Pharmaceutical Form: Capsule
INN or Proposed INN: Colony-purified Bacteroides thetaiotaomicron (B.theta)
Current Sponsor code: MRx1233 (previously LBP001)
Other descriptive name: B. theta
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: range
Concentration number: 1E+7 to 1E+10-CFU/g
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
4D PharmaAuthorisedFemale: yes
Male: yes
Phase 1United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
286NCT02531113October 9, 201530 September 2019Efficacy 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: RPC1063CelgeneNot recruiting18 Years75 YearsAll69Phase 2United States;Canada;Hungary;Poland;Ukraine;Italy
287NCT02177071October 201521 January 2019A 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 TherapyCrohn's DiseaseDrug: INFLIXIMAB;Drug: AZATHIOPRINE;Drug: MERCAPTOPURINE;Drug: MethotrexateGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesSaint-Louis Hospital, Paris, FranceRecruiting18 Years65 YearsAll300Phase 4Australia;Belgium;France
288NCT02520843October 201528 January 2019An 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 MarseilleNot recruiting18 YearsN/AAll10Phase 1/Phase 2France
289NCT02847884October 201511 June 2019IDeaL Pilot Study - Infliximab Dose to Level: Pilot StudyIDeaL Pilot Study - Infliximab Dose to Level: Pilot StudyInflammatory Bowel Disease;Crohn's DiseaseBiological: InfliximabUniversity of AlbertaThe Hospital for Sick Children;The Children's Hospital of Winnipeg;Alberta Children's Hospital;Provincial Health Services Authority;Children's Hospital of Eastern OntarioNot recruiting2 Years17 YearsAll28Phase 2Canada
290EUCTR2013-003199-11-BE25/09/201528 May 2018CUREChanging the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURECrohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Adalimumab
Product Name: Humira
Pharmaceutical Form: Injection
GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires DigestivesAuthorisedFemale: yes
Male: yes
200Phase 4France;Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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291EUCTR2015-001834-15-ES24/09/201512 October 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 diseaseCrohn'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 Code: BI 655066 10 mg/ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not available yet
Current Sponsor code: BI 655066
Other descriptive name: BI 655066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Product Code: BI 655066 90 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: not available yet
Current Sponsor code: BI 655066
Other descriptive name: BI 655066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Boehringer Ingelheim España, S.A.AuthorisedFemale: yes
Male: yes
62United States;Canada;Spain;Germany;Korea, Republic of
292NCT02513459September 16, 201515 July 2019A 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 DiseaseCrohn DiseaseDrug: ABBV-066AbbVieBoehringer IngelheimNot recruiting18 Years75 YearsAll65Phase 2United States;Belgium;Canada;Germany;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom
293NCT02417974September 201524 June 2019Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)Crohn's DiseaseBiological: Fecal Microbiota Transplant (FMT)Beth Israel Deaconess Medical CenterBrigham and Women's Hospital;Boston Medical Center;Massachusetts Institute of TechnologyRecruiting18 YearsN/AAll44Phase 2United States
294NCT02522169September 201524 August 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 GmbHNot recruiting6 Years17 YearsBoth120N/A
295NCT03010787September 201516 December 2017A 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.Not recruiting18 Years65 YearsAll47Phase 1United Kingdom
No.TrialIDDate_
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296EUCTR2014-004108-31-HU27/08/201529 August 2016Study 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 EUModerately 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
Pharmaceutical Form: Capsule
INN or Proposed INN: Clarithromycin
CAS Number: 81103-11-9
Other descriptive name: CLARITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 95-
INN or Proposed INN: Rifabutin
CAS Number: 72559-06-9
Other descriptive name: RIFABUTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
INN or Proposed INN: Clofazimine
CAS Number: 2030-63-9
Other descriptive name: CLOFAZIMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
RedHill Biopharma Ltd.Not RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Slovakia;Belgium;Spain;Ukraine;Ireland;Russian Federation;Netherlands;Germany;United Kingdom
297EUCTR2014-003824-36-SE12/08/201517 September 2018A 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 OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASECrohn`s 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 210-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
F. Hoffmann-La Roche LtdAuthorisedFemale: 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
298EUCTR2014-003855-76-SE12/08/201517 September 2018An 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 GA29144Crohn`s 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
F. Hoffmann-La Roche LtdAuthorisedFemale: 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
299NCT02538679August 7, 201516 December 2017A 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 CenterNot recruiting18 Years90 YearsAll127N/A
300NCT02193750August 201511 June 2018Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's DiseaseAssessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled TrialCrohn's DiseaseDietary Supplement: Placebo;Dietary Supplement: Moderate Oligosaccharide Group;Dietary Supplement: High Oligosaccharide GroupUniversity of British ColumbiaThe Alfred;Melbourne HealthRecruiting19 YearsN/AAll48N/AAustralia;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
301NCT02389790August 201516 December 2017Extension 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 CorporationNot recruiting18 Years65 YearsAll46Phase 2Czechia;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine;Czech Republic
302NCT02452151August 20151 June 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 recruiting18 YearsN/ABoth300Phase 4
303NCT02499783July 27, 201529 January 2018Study 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: PlaceboAbbVieNot recruiting18 Years70 YearsAll205Phase 3China
304EUCTR2015-001179-36-PL24/07/201530 April 2019Study 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 DiseaseModerately 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: RHB-104
Pharmaceutical Form: Capsule
INN or Proposed INN: Clarithromycin
CAS Number: 81103-11-9
Other descriptive name: CLARITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 95-
INN or Proposed INN: Rifabutin
CAS Number: 72559-06-9
Other descriptive name: RIFABUTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
INN or Proposed INN: Clofazimine
CAS Number: 2030-63-9
Other descriptive name: CLOFAZIMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
RedHill Biopharma Ltd.Not Recruiting Female: yes
Male: yes
324Phase 3Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
305NCT02646683July 201513 May 2019A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD StudyAn 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)Crohn DiseaseDrug: vedolizumabGeert D'HaensTakedaRecruiting18 Years80 YearsAll260Phase 4Belgium;Hungary;Netherlands
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
306EUCTR2014-005376-29-NL29/06/20154 August 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-CDActive Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Pharmaceutical Form: Powder for concentrate for dispersion for infusion
Academic Medical Center, GastroenterologyAuthorisedFemale: yes
Male: yes
260Phase 4Netherlands
307EUCTR2014-001050-41-DE12/06/201528 February 2019Randomized 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 - REACT2Crohn'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
Pharmaceutical Form: Solution for injection
Robarts Clinical TrialsAuthorised Female: yes
Male: yes
1200Phase 4United States;Canada;Germany;United Kingdom
308NCT02403323June 8, 20154 November 2019Open-Label Extension and Safety Study for Patients 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 RocheRecruiting18 YearsN/AAll900Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic
309EUCTR2014-004904-31-NL19/05/20155 September 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)
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Mundipharma Pharmaceuticals B.V.AuthorisedFemale: yes
Male: yes
Phase 4Netherlands
310NCT02256462May 1, 201525 February 2019Pediatric 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, IsraelNot recruiting6 Years17 YearsAll82Phase 4Israel
No.TrialIDDate_
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PhaseCountries
311NCT02413047May 201516 December 2017Evaluate 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 UniversityRecruiting18 Years80 YearsAll20N/AUnited States
312NCT02423460May 201519 November 2018Threonine Requirement in IBD Adults and Healthy Adult ControlsThreonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) MethodologyUlcerative Colitis;Crohn's Disease;HealthyOther: ThreonineNestléThe Hospital for Sick Children;Mount Sinai Hospital, CanadaNot recruiting18 Years40 YearsMale86N/ACanada
313NCT02575040May 201526 October 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 AcademyRecruiting18 YearsN/ABoth60Phase 3Turkey
314NCT02405442April 30, 201523 April 2019Safety 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 SciencesNot recruiting18 Years75 YearsAll187Phase 2United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Czech Republic;Iceland
315NCT02539368April 22, 201526 August 2019Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel DiseasePOST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's DiseaseDrug: CT-P13;Drug: RemicadePfizerHospira, now a wholly owned subsidiary of PfizerNot recruiting18 YearsN/AAll2565Phase 3Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
316NCT02425111April 13, 201516 December 2017Effect 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: VedolizumabTakedaNot recruiting18 Years80 YearsAll101Phase 3United States;Belgium;Canada;Czechia;France;Hungary;Italy;Poland;Czech Republic
317NCT02367183April 8, 201521 January 2019A 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: PlaceboCelgeneNot recruiting18 YearsN/AAll64Phase 1United States;Australia;Canada;Hungary;Slovakia
318NCT02208310April 201516 December 2017Trial of High Dose Vitamin D in Patient's With Crohn's DiseaseA Randomized Controlled Trial of High-Dose Vitamin D in Crohn's DiseaseCrohn's Disease;Vitamin D DeficiencyDrug: Cholecalciferol 10,000 IU;Drug: Cholecalciferol 400 IUUniversity of MichiganCrohn's and Colitis FoundationNot recruiting18 Years75 YearsAll11Phase 4United States
319NCT02517684April 201525 February 2019Top-down Infliximab Study in Kids With Crohn's DiseaseTop-down Infliximab Study in Kids With Crohn's DiseaseCrohn's DiseaseDrug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: AzathioprineErasmus Medical CenterZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of PfizerNot recruiting3 Years17 YearsAll100Phase 4Belgium;Finland;Netherlands;Denmark;Italy;Poland
320NCT02580617April 201522 January 2018A 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.Recruiting18 Years65 YearsAll9Phase 1Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
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sponsor
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PhaseCountries
321NCT02851134April 201511 March 2019Search 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, LilleNot recruiting5 Years80 YearsAll20N/AFrance
322NCT02674308March 31, 201514 October 2019Entyvio (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 AgentsTakedaNot recruiting18 YearsN/AAll5302N/AUnited States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
323NCT02394028March 20, 20154 November 2019A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants With Moderately to Severely Active Crohn's Disease (CD)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 DiseaseCrohn DiseaseDrug: Etrolizumab;Drug: PlaceboHoffmann-La RocheRecruiting18 Years80 YearsAll1150Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic
324NCT02365649March 17, 201516 December 2017A 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: PlaceboAbbVieNot recruiting18 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
325NCT03306446March 17, 20158 April 2019Changing 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 DigestivesNot recruiting18 Years75 YearsAll203Phase 4Belgium;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
326NCT02675153March 1, 201516 December 2017To Evaluate the Efficacy and Safety of Sirolimus for Crohn's Disease With StenosisEfficacy and Safety of Sirolimus in the Treatment of Crohn's Disease With StenosisCrohn's DiseasesDrug: Sirolimus;Drug: 5-ASA, Prednisone, Azathioprine or RemicadeThe Second Hospital of Nanjing Medical UniversityXijing Hospital of Digestive DiseasesRecruiting18 Years70 YearsAll50Phase 4China
327NCT01836289March 201520 August 2018High-dose Cyclophosphamide for Severe Refractory Crohn DiseaseHigh-dose Cyclophosphamide for Severe Refractory Crohn DiseaseCrohn's Disease;Crohn DiseaseDrug: High-dose CyclophosphamideJohns Hopkins UniversityNot recruiting18 Years100 YearsAll0Phase 1/Phase 2United States
328NCT02378688March 201524 October 2016Safety 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 CorporationNot recruiting18 Years65 YearsBoth78Phase 2Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine
329NCT02392286March 201518 January 2018Corticosteroid 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 UniversityRecruiting18 YearsN/AAll182Phase 4United States
330EUCTR2014-001645-24-DE09/02/201528 February 2019A 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 DiseaseTreatment 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)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaxmin DR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Salix Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
331EUCTR2014-001644-38-DE02/02/201528 February 2019A 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 DiseaseTreatment 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)
Pharmaceutical Form: Tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaxmin DR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Salix Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
660Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany
332NCT02061163February 201529 June 2015Contrast-Enhanced Ultrasound in Human Crohn's DiseaseEvaluation of Contrast-Enhanced Ultrasound in Human Crohn's DiseaseCrohn's DiseaseDevice: Contrast Enhanced Ultrasound;Drug: OptisonUniversity of MichiganNot recruiting10 YearsN/ABoth0Phase 1/Phase 2United States
333NCT02321280February 201522 October 2018The Efficacy of Denosumab in Active Crohn's DiseaseDenosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's DiseaseCrohn DiseaseDrug: DenosumabUniversity of ManitobaUniversity of Toronto;McMaster UniversityNot recruiting18 Years80 YearsAll2Phase 1/Phase 2Canada
334JPRN-UMIN0000324852015/01/012 April 2019efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's diseaseCron's diseaseadalimumab
azathiopurine
Sakura medical center, Toho universityRecruiting20years-old70years-oldMale and Female20Not selectedJapan
335NCT02272868January 201511 June 2018Fecal 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 HospitalNot recruiting12 Years21 YearsAll7Phase 1/Phase 2United States
No.TrialIDDate_
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336NCT02335281January 201519 February 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 WeiRecruiting16 Years70 YearsBoth40Phase 2China
337EUCTR2015-002882-41-AT1 February 2016A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s diseaseSono-­Response-­Study A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s diseaseInflammatory 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
Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion
INN or Proposed INN: sulphur hexafluoride
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration unit: µl/ml microlitre(s)/millilitre
Concentration type: equal
Concentration number: 8-
Medical University of Vienna (MUW)AuthorisedFemale: yes
Male: yes
Austria
338NCT02201693December 12, 201429 April 2019Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's DiseaseRandomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's DiseaseCrohn's DiseaseDietary Supplement: MODULEN IBDAssistance Publique - Hôpitaux de ParisGETAID PediatricNot recruiting6 Years18 YearsAll100N/AFrance
339EUCTR2014-001295-65-AT01/12/201414 November 2016Phase 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) - CATS29Moderately 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
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Ova-Treg
CAS Number: -
Current Sponsor code: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
Concentration unit: Other
Concentration type: equal
Concentration number: 10e6-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intravenous use
TxCellNot RecruitingFemale: yes
Male: yes
170Phase 2Belgium;Austria;Germany;Italy
340NCT02249078December 201417 November 2015A 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.Not recruiting18 YearsN/ABoth0Phase 1
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
341NCT02255370December 20148 August 2016Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn DiseaseControlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn DiseaseCrohn's DiseaseDrug: CurcuminUniversity Hospital, Clermont-Ferrand3i nature;Naturopôle Nutrition santéRecruiting18 YearsN/ABoth122Phase 3France
342NCT02539849December 201412 February 2018Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s DiseaseEffect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s DiseaseCrohn DiseaseDietary Supplement: FOS;Drug: AdalimumabHospital Universitari Vall d'Hebron Research InstituteAbbVieNot recruiting18 Years65 YearsAll38N/ASpain
343EUCTR2014-001295-65-BE28/11/201431 October 2016Phase 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) - CATS29Moderately 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
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Ova-Treg
CAS Number: -
Current Sponsor code: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
Concentration unit: Other
Concentration type: equal
Concentration number: 10e6-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intravenous use
TxCellNot RecruitingFemale: yes
Male: yes
117Phase 2Belgium;Austria;Germany;Italy
344EUCTR2014-002556-77-CZ27/11/201421 November 2016A 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 DiseaseSubjects 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Mitsubishi Tanabe Pharma Corporation (MTPC)Not RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
345EUCTR2014-002557-19-CZ27/11/20146 November 2017A 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 StudySubjects 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Mitsubishi Tanabe Pharma Corporation (MTPC)Not RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
346EUCTR2014-001892-30-BE24/11/201417 August 2015Placebo-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 DiseaseCrohn’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
Pharmaceutical Form: Capsule, hard
Current Sponsor code: G321605
Other descriptive name: GLPG1205
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Galapagos NVNot RecruitingFemale: yes
Male: yes
120Phase 2France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Russian Federation;Germany;United Kingdom
347EUCTR2014-001644-38-HU18/11/201428 February 2019A 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 DiseaseTreatment 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]
Product Name: Rifaximin Delayed Release (DR)
Pharmaceutical Form: Tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaxmin DR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Salix Pharmaceuticals, Inc.Not Recruiting Female: yes
Male: yes
660Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany
348EUCTR2014-001645-24-HU18/11/201428 February 2019A 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 DiseaseTreatment 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]
Product Name: Rifaximin Delayed Release (DR)
Pharmaceutical Form: Tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: Rifaxmin DR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Salix Pharmaceuticals, Inc.Not Recruiting Female: yes
Male: yes
660Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany
349NCT02453607November 17, 201416 December 2017The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's DiseaseThe Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's DiseaseInflammatory Bowel Disease;Crohn's DiseaseDrug: Infliximab;Drug: thiopurineErnest SeidmanUniversity of Toronto;University of Calgary;University of AlbertaRecruiting18 Years70 YearsAll225N/ACanada
350NCT02240108October 28, 201430 September 2019One Year Study of Rifaximin Delayed Release (DR) in Crohn's DiseaseA 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 DiseaseCrohn's DiseaseDrug: Rifaximin EIR;Drug: PlaceboBausch Health Americas, Inc.Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLCNot recruiting18 YearsN/AAll81Phase 3United States
No.TrialIDDate_
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351EUCTR2013-001746-33-DK23/10/201428 February 2019A 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 UlcerationCrohn's 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
AbbVie Deutschland GmbH & Co. KGAuthorised Female: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
352EUCTR2013-001746-33-DE08/10/201428 February 2019A 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 UlcerationCrohn's 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
AbbVie Deutschland GmbH & Co. KGAuthorised Female: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
353NCT02148640October 201416 December 2017The NOR-SWITCH StudyA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDYRheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis ChronicDrug: Innovator infliximab;Drug: Biosimilar infliximabDiakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityNot recruiting18 YearsN/AAll482Phase 4Norway
354EUCTR2014-003141-10-BE29/09/20146 January 2015Invloed 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 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: UrsoFalk® 250 mg tabletten.
Product Name: UrsoFalk
Pharmaceutical Form: Tablet
INN or Proposed INN: ursodeoxycholic acid
CAS Number: 128-13-2
Other descriptive name: URSODEOXYCHOLIC ACID
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Ghent University HospitalAuthorisedFemale: yes
Male: yes
Belgium
355NCT02096861September 19, 201411 June 2018Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's DiseaseA Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's DiseaseCrohn's DiseaseBiological: CT-P13;Biological: RemicadeCelltrionPfizerNot recruiting18 Years75 YearsAll220Phase 3United States
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
356JPRN-UMIN0000157702014/09/017 October 2019Randomized 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 ResearchNot Recruiting20years-old70years-oldMale and Female30Not selectedJapan
357NCT02108821September 201416 December 2017Fecal Microbiota Transplantation in Pediatric PatientsA Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease.Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC)Biological: Fecal Microbiota Transplantation (FMT)Children's Mercy Hospital Kansas CityUniversity of PittsburghNot recruiting2 Years22 YearsAll23Phase 1United States
358NCT02154425September 201411 June 2018A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating MothersA Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Breast milk sampling;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelNot recruiting18 YearsN/AFemale17Phase 1United States;Netherlands;Switzerland;France
359NCT02332356September 201423 April 2019Therapeutic 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 UniversityRecruiting16 Years65 YearsAll100Phase 3Japan
360NCT02240121August 21, 201430 September 2019One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's DiseaseA 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 DiseaseCrohn's DiseaseDrug: Rifaximin EIR;Drug: PlaceboBausch Health Americas, Inc.Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLCNot recruiting18 YearsN/AAll80Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
361EUCTR2013-005629-21-HU14/08/201428 August 2014Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s diseaseDiagnostic use of 99mTecnetium labeled infliximab in Crohn’s diseaseCrohn’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
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
First Department of Medicine, University of SzegedAuthorisedFemale: yes
Male: yes
Hungary
362NCT02185014August 12, 201416 December 2017Open 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: AdalimumabAbbVieNot recruiting18 Years75 YearsAll246Phase 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
363JPRN-UMIN0000140062014/08/012 April 2019Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's diseaseCrohn's diseasedose escalation of infliximabIBD Center, Sapporo Kosei General HospitalRecruiting18years-oldNot applicableMale and Female20Not selectedJapan
364NCT02000362August 201416 December 2017Safety 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.Recruiting19 Years70 YearsAll24Phase 1/Phase 2Korea, Republic of
365NCT02199561July 20149 January 2017Fecal 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 AlbertaNot recruiting18 Years65 YearsBoth3Phase 1/Phase 2Canada
No.TrialIDDate_
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366EUCTR2013-001746-33-ES23/06/201428 February 2019A 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 UlcerationCrohn'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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
AbbVie Deutschland GmbH & Co. KGNot 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
367NCT02164877June 201411 June 2018Effect 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, ChinaNot recruiting17 Years40 YearsAll3Phase 2China
368NCT02179372June 201412 December 2016Eicosapentaenoic 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 MalpighiNot recruiting18 Years80 YearsBoth60N/AItaly
369NCT01881464May 201419 February 2015Anti 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 CenterRecruiting18 Years40 YearsBoth20Phase 4Israel
370NCT02148185May 201419 February 2015Pharmacokinetics (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 CorporationNot recruiting20 Years65 YearsBoth1Phase 1Japan
No.TrialIDDate_
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371EUCTR2013-004781-34-ES16/04/201413 February 2017Rapidity 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Product Name: ADALIMUMAB
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Product Name: ADALIMUMAB
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
AbbVie Farmacéutica S.L.U.Not RecruitingFemale: yes
Male: yes
Phase 4Spain
372NCT02065570April 9, 201418 December 2018Study 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: AdalimumabAbbVieNot recruiting18 Years75 YearsAll514Phase 3Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;United States;Czech Republic
373EUCTR2013-005013-13-LT08/04/201416 November 2015A 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 TherapySubjects 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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Other descriptive name: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Humira®
Product Name: Humira®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: not applicable
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Samsung Bioepis Co., Ltd.Not RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
374EUCTR2013-001029-17-NL01/04/201414 April 2014Dose 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 - REDIXCrohn'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
Pharmaceutical Form: Powder for concentrate for solution for infusion
Academic Medical CenterAuthorisedFemale: yes
Male: yes
Netherlands
375JPRN-UMIN0000133692014/04/012 April 2019Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's diseaseCrohn'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 medicineNot Recruiting20years-old70years-oldMale and Female240Phase 2Japan
No.TrialIDDate_
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PhaseCountries
376NCT01960426April 201423 May 2016Evaluation of Health Costs and Resource UtilizationA Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.Ulcerative Colitis;Crohn's DiseaseOther: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drugUniversity of Western Ontario, CanadaPrometheus LaboratoriesNot recruiting18 YearsN/ABoth51Phase 4United States
377NCT02913508April 20143 October 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 subcutaneous injection;Drug: Vedolizumab intravenous injectionTakedaNot recruiting18 Years80 YearsBoth0Phase 2
378ChiCTR-DDT-140044022014-03-2818 April 2017The 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 fastingObscure 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 UniversityNot Recruiting1085BothGroup A:60;Group B:60;Group C:60;Phase 4 studyChina
379JPRN-UMIN0000142052014/03/2516 July 2019Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patientExamination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient - Validity of pancrelipase in patients with inflammatory bowel diseaseCrohn's disease Ulcerative colitisAdministration of pancrelipaseDepartment of Gastroenterology Osaka City University Graduate School of MedicineNot Recruiting20years-oldNot applicableMale and Female30Not selectedJapan
380NCT02039063March 14, 201421 January 2019A 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.Not recruiting20 Years64 YearsAll28Phase 1/Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
381NCT01908283March 20149 January 2017Induction of Immunity Against Streptococcus Pneumoniae in Adults With Inflammatory Bowel DiseaseInfluence of Immunosuppressive Treatment on Immunological Response to Pneumococcal Conjugated Vaccine (PCV13) in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Diseases;Crohn Disease;Colitis, UlcerativeBiological: 13-valent pneumococcal conjugated vaccine (PCV13)Klara M. Pósfay BarbeSwiss IBD Cohort Study;Foundation for liver and gut studies (FLAGS);Schweizerische Morbus Crohn / Colitis ulcerosa Vereinigung (SMCCV)Not recruiting18 Years99 YearsBoth300Phase 4Switzerland
382NCT02088944March 201419 February 2015a 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 UniversityNot recruiting18 Years75 YearsBoth142N/A
383NCT02281916March 201418 June 2018Safety Study of P28GST Treatment in Crohn's Disease PatientsSafety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical TrialCrohn's IleocolitisDrug: P28GSTUniversity Hospital, LilleNational Research Agency, France;Institut National de la Santé Et de la Recherche Médicale, FranceNot recruiting18 YearsN/AAll10Phase 2France
384EUCTR2013-002857-32-DE20/02/201428 November 2016A 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 UlcerationCrohn’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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FILGOTINIB
CAS Number: 1206161-97-8
Current Sponsor code: GLPG0634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Galapagos NVNot RecruitingFemale: yes
Male: yes
180Phase 2France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom
385NCT01986127February 14, 201418 December 2018Adalimumab 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 PatientsCrohn's DiseaseDrug: Adalimumab;Drug: placeboSara VareaHospital Clinic of BarcelonaNot recruiting18 YearsN/AAll26Phase 3Spain
No.TrialIDDate_
enrollement
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PhaseCountries
386NCT02060318February 11, 201416 December 2017Regulatory T-cells and Crohn's DiseaseThe Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cellsCrohn DiseaseDrug: InfliximabHvidovre University HospitalNot recruiting18 YearsN/AAll47N/ADenmark
387JPRN-UMIN0000127902014/02/012 April 2019Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's DiseaseCrohn's diseasedose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 monthsSaitama Medical centerNot Recruiting20years-old65years-oldMale and Female20Not selectedJapan
388NCT01783106February 1, 20144 November 2019Antibiotics and Hydroxychloroquine in Crohn'sA Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's DiseaseCrohn's DiseaseDrug: Ciprofloxacin;Drug: Doxycycline;Drug: Hydroxychloroquine;Drug: BudesonideRoyal Liverpool University HospitalNational Association for Colitis and Crohn's Disease;National Institute for Health Research, United KingdomNot recruiting18 YearsN/AAll59Phase 2United Kingdom
389NCT01765439February 201420 August 2018The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel DiseaseThe Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel DiseaseCrohn Disease;Ulcerative ColitisDietary Supplement: VSL#3 (Original De Simone formulation)Charles University, Czech RepublicIscare i.v.f., Czech Republic;CD Investments srl;University Of Perugia;University of Roma La SapienzaRecruitingN/AN/AAll80N/ACzechia;Czech Republic
390NCT01932658February 201425 April 2016Autologous 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 AngelesNot recruiting7 Years70 YearsBoth0Phase 0United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
391JPRN-JapicCTI-14240228/1/201416 July 2019Phase 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 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 LimitedNot Recruiting1580BOTH157Phase 3Japan
392EUCTR2013-002902-29-BE09/01/20149 January 2017Efficacy, 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
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: BI 655066
Other descriptive name: BI 655066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Code: BI 655066 90 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: BI 655066
Other descriptive name: BI 655066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
SCS Boehringer Ingelheim Comm.VNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
393NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
394NCT02019602January 201416 December 2017A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the PlacentaA Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelNot recruiting18 YearsN/AAll16Phase 1United States;France;Netherlands;Switzerland
395NCT02044952January 201419 February 2015Efficacy 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 WeimingRecruiting18 Years75 YearsBoth40Phase 2/Phase 3China
No.TrialIDDate_
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396NCT02056418January 201419 February 2015Effects 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, ChinaNot recruiting18 Years75 YearsBoth30Phase 4China
397NCT02615288January 20147 December 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 GastroenterologyNot recruiting18 Years70 YearsBoth40N/A
398EUCTR2011-001332-29-AT02/12/201327 October 2014The degradation and elimination of InfliximabPharmacokinetics of InfliximabInflammatory 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
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remicade
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und HepatologieAuthorisedFemale: yes
Male: yes
Austria
399NCT02015793December 201311 June 2018Study 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 adalimumabAbbVieNot recruiting18 Years70 YearsAll30Phase 2China
400EUCTR2012-004222-25-BE26/11/201316 August 2016Comparison 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 diseaseCrohn'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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: not applicable
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: not applicable
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
AB ScienceAuthorisedFemale: 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_
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401EUCTR2013-002838-20-NL12/11/201329 January 2018The 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) - DETECTCrohn'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
Pharmaceutical Form: Oral solution
INN or Proposed INN: Colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 25000-
Pharmaceutical form of the placebo: Oral drops, solution
Route of administration of the placebo: Oral use
Academic Medical CenterNot RecruitingFemale: yes
Male: yes
142Phase 3Belgium;Netherlands
402EUCTR2012-001723-12-ES07/10/20134 December 2018adalimumab 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 patientsCrohn 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intralesional use
Fundació Clínic per a la Recerca BiomèdicaNot RecruitingFemale: yes
Male: yes
102Phase 3Spain
403NCT02859675October 7, 201326 August 2019Olfactogustatory 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 DijonRecruiting18 Years60 YearsFemale75N/AFrance
404NCT01674413October 201316 December 2017Calprotectin-Directed Humira® Maintenance Therapy (CADHUM)Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's DiseaseCrohn's DiseaseDrug: Adalimumab;Drug: Adalimumab PRN;Drug: PlaceboPeter HigginsAbbVieNot recruiting18 YearsN/AAll0Phase 3United States
405NCT02538757October 201321 August 2017Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE)Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory ArthritisBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityNot recruiting50 YearsN/AAll125Phase 2United States
No.TrialIDDate_
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406JPRN-JapicCTI-14242601/9/20132 April 2019A 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 DiseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 80mg every other week
Control intervention name : null
AbbVie GK15BOTH28Phase 3
407NCT01951326September 201311 March 2019Efficacy 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 LimitedNot recruiting18 Years75 YearsAll330Phase 3United States;Australia;Bulgaria;Canada;Czechia;Israel;New Zealand;Poland;Serbia;Slovakia;Czech Republic
408NCT01958827September 201319 October 2017A 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: AdalimumabAbbVieNot recruiting15 YearsN/AAll28Phase 3Japan
409EUCTR2013-002932-25-NL21/08/201328 February 2019A 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-trialPerianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion
Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Powder for concentrate for solution for infusion
Academic Medical CenterNot Recruiting Female: yes
Male: yes
126Phase 4Netherlands
410EUCTR2013-000971-34-DK01/08/201330 April 2019High 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 - MirViDiCActive 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]
Trade Name: Dekristol 20.000 ie
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: cholecalciferol
Other descriptive name: CHOLECALCIFEROL
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 20000-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Remsima
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Jørgen AgnholtNot Recruiting Female: yes
Male: yes
50Phase 3Denmark
No.TrialIDDate_
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PhaseCountries
411NCT01523106August 201319 February 2015L-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 FranciscoNot recruiting18 Years70 YearsBoth0N/AUnited States
412EUCTR2013-001212-30-NL04/07/20134 November 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 studyCrohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Omegaven
Pharmaceutical Form: Emulsion for infusion
Trade Name: Intralipid 10%
Pharmaceutical Form: Solution for infusion
AuthorisedFemale: yes
Male: yes
Netherlands
413NCT01864616July 201311 June 2018The Impact of Vitamin D on Disease Activity in Crohn's DiseaseCrohn DiseaseDietary Supplement: Vitamin D3University of SaskatchewanDania Alrefai;Dr.Jennifer Jones;Dr.Hani Jawa;Dr.Wael El-matary;Saudi Arabian Cultural BureauNot recruiting16 Years70 YearsAll9N/ACanada;Saudi Arabia
414NCT01915927July 201326 August 2019Stem 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.Not recruiting18 Years65 YearsAll20Phase 1United States
415NCT01947010July 201319 February 2015Pneumococcal Vaccination of Crohn PatientsPneumococcal 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 DiseaseCrohns DiseaseBiological: Prevenar 13;Biological: PneumovaxStatens Serum InstitutHvidovre University Hospital;Herlev HospitalNot recruiting18 YearsN/ABoth151Phase 4Denmark
No.TrialIDDate_
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416EUCTR2013-001503-37-DK31/05/201310 July 2015Effect 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 DiseaseInflammatory 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
Pharmaceutical Form: Tablet
INN or Proposed INN: azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Allopurinol
Pharmaceutical Form: Tablet
INN or Proposed INN: allopurinol
CAS Number: 17795-21-0
Other descriptive name: ALLOPURINOL SODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Marianne Kiszka-KanowitzNot RecruitingFemale: yes
Male: yes
46Denmark
417NCT01827631May 27, 201316 December 2017Single 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 capsuleGlaxoSmithKlineNot recruiting18 Years45 YearsAll21Phase 1China
418NCT01847170May 201316 December 2017Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel DiseaseCrohn's DiseaseBiological: Fecal Microbial TransplantationBeth Israel Deaconess Medical CenterThe Broad Foundation;Brigham and Women's HospitalNot recruiting18 YearsN/AAll22Phase 1United States
419NCT02073526May 20139 January 2017Anti-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 HospitalNot recruiting18 YearsN/ABoth1230N/ANorway
420NCT02233062May 201319 February 2015Impact 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, ChinaNot recruiting18 Years40 YearsMale12N/AChina
No.TrialIDDate_
enrollement
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PhaseCountries
421NCT02676622April 201316 December 2017Autologous 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 HospitalNot recruiting12 Years29 YearsAll0Phase 2
422JPRN-UMIN0000105242013/03/292 April 2019Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudyCrohn'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 GastroenterologyNot Recruiting15years-oldNot applicableMale and Female20Not selectedJapan
423NCT01804166March 21, 201330 September 2019A 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, LLCRecruitingN/AN/AAll40Phase 4United States
424NCT01769755March 201312 March 2018A 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 IncorporatedNot recruiting18 Years75 YearsAll14Phase 1United States
425NCT01809275March 201329 August 2016Safety 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.Not recruiting18 YearsN/ABoth68Phase 1/Phase 2Canada
No.TrialIDDate_
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PhaseCountries
426NCT01810185March 201319 February 2015Low 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 HospitalNot recruiting18 YearsN/ABoth0Phase 2United States
427NCT01817972March 201319 February 2015Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's DiseaseA Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Certolizumab pegol;Drug: AzathioprineGastroenterology Research of AmericaUCB PharmaNot recruiting18 Years70 YearsBoth65Phase 3United States
428NCT01826188March 201318 March 2019Combined 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 CenterNot recruiting20 Years85 YearsAll50Phase 1/Phase 2Israel
429NCT01828190March 201319 February 2015The 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 CenterRecruiting18 Years70 YearsBoth50N/AIsrael
430EUCTR2012-002867-86-DK13/02/201331 August 2015Prevention 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 - PneuVacCrohn'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
Pharmaceutical Form: Solution for injection/infusion
Trade Name: Prevenar 13
Product Name: Prevenar 13
Pharmaceutical Form: Solution for injection
Statens Serum InstitutNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
431NCT01768858February 5, 201311 February 2019Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeCrohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: AdalimumabAbbVieRaffeiner GmbHNot recruiting18 Years99 YearsAll96Phase 2Austria
432NCT01714726February 1, 201318 March 2019Evaluation 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: placeboAllerganNot recruiting18 Years65 YearsAll121Phase 2United States;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;Czech Republic
433NCT01696942February 201316 December 2017Cimzia Versus Mesalamine for Crohn's RecurrenceUse of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to MesalamineCrohn's DiseaseDrug: Cimzia;Drug: MesalamineMilton S. Hershey Medical CenterUCB PharmaNot recruiting18 YearsN/AAll10Phase 4United States
434NCT01765998February 201319 February 2015The 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, PoriyaNot recruiting18 Years60 YearsBoth60Phase 4Israel
435NCT01802593February 20134 January 2016Comparison 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 LevineNot recruiting6 Years18 YearsBoth20Phase 4Israel
No.TrialIDDate_
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436NCT01874015February 201316 December 2017Transplantation 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 InstituteRecruiting18 Years65 YearsAll10Phase 1Iran, Islamic Republic of
437NCT02010762February 201316 December 2017The 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)Not recruiting18 YearsN/AAll142Phase 4Netherlands
438EUCTR2012-002432-93-CZ18/01/201324 August 2015A 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 diseaseCrohns 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: N/A
Current Sponsor code: NNC0114-0006
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use
Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes
114Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria
439JPRN-UMIN0000095962013/01/012 April 2019Withdrawal 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 UniversityNot Recruiting15years-oldNot applicableMale and Female200Not selectedJapan
440NCT02501291January 201314 March 2016Thalidomide in Treating Crohn's DiseaseThalidomide in Inducing and Maintaining Remission of Crohn's DiseaseCrohn's DiseaseDrug: ThalidomideFirst Affiliated Hospital, Sun Yat-Sen UniversityNot recruiting18 Years75 YearsBoth47Phase 2China
No.TrialIDDate_
enrollement
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PhaseCountries
441NCT01696396December 4, 201220 August 2018AMG 181 in Subjects 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: AMG 181;Other: PlaceboAmgenNot recruiting18 Years65 YearsAll254Phase 2United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Netherlands;Switzerland;United Kingdom;Czech Republic
442NCT01078935December 201219 February 2015The 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 recruiting18 Years80 YearsBoth100Phase 4
443NCT01735461December 201211 June 2018Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's PatientsOral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel ResectionKidney Calculi;Crohn's DiseaseDietary Supplement: Calcium CarbonateUniversity of British ColumbiaUniversity of Texas Southwestern Medical CenterRecruiting19 YearsN/AAll40N/ACanada
444NCT01752790December 201219 February 2015Efficacy 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 SapienzaNot recruiting6 Years18 YearsBoth0Phase 4Italy
445NCT01757964December 201216 December 2017Bacteriotherapy in Pediatric Inflammatory Bowel DiseaseBacteriotherapy in Pediatric Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CDBiological: BacteriotherapyDavid SuskindSeattle Children's HospitalNot recruiting12 Years21 YearsAll13Phase 1United States
No.TrialIDDate_
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446NCT01820247December 201219 February 2015Efficacy 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 WeimingRecruiting18 Years75 YearsBoth100N/AChina
447JPRN-UMIN0000092842012/11/2021 May 2019The 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 DiseaseCrohn'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 universityNot Recruiting18years-old65years-oldMale and Female20Phase 2Japan
448EUCTR2012-000529-31-BE09/11/201211 June 2018A 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 DiseaseModerate 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 181
Current Sponsor code: AMG 181
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Amgen IncNot RecruitingFemale: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
449NCT01349920November 201219 October 2017Biomarkers 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.Not recruiting18 Years60 YearsAll15N/AMoldova, Republic of;United Kingdom
450NCT01817426November 201219 February 2015Discontinuation 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 HerlevRecruiting18 YearsN/ABoth136Phase 4Denmark
No.TrialIDDate_
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451NCT01823029November 201219 February 2015Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency AnemiaCrohn's DiseaseDrug: erythropoietin;Drug: enteral nutrition.;Drug: injection of ironJinling Hospital, ChinaMinistry of Health, ChinaNot recruiting18 Years75 YearsBoth387N/AChina
452EUCTR2012-000645-13-NL17/10/20125 August 2014Infliximab as first treatment instead of second line treatment in Crohns diseaseInfliximab Top-down Study in Kids with Crohn’s disease - ITSKIDSCrohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
ErasmusMCAuthorisedFemale: yes
Male: yes
90Belgium;Netherlands;Italy
453EUCTR2011-006084-22-GB04/10/201216 October 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 diseaseInflammatory 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
Pharmaceutical Form: Infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Current Sponsor code: Centocor
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10mg/kg body wt-
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Current Sponsor code: EU/1/03/256/001
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 40-mg
Royal Liverpool University HospitalAuthorisedFemale: yes
Male: yes
0United Kingdom
454NCT01562951October 201217 May 2016Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With ImmunosuppressantscAlprotectin 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 ImmunosuppressantsCrohn's Disease;Mucosal InflammationDrug: ADALIMUMAB;Drug: PlaceboGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaAbbott;TFS Trial Form SupportNot recruiting18 Years75 YearsBoth15Phase 3Belgium;France;Spain
455NCT01596894October 201216 December 2017Azithromycin 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 LevineNot recruiting5 Years17 YearsAll73Phase 4Israel
No.TrialIDDate_
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456NCT01692808October 201217 November 2015Bioavailability 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 HospitalNot recruiting10 Years18 YearsBoth20Phase 2Canada
457NCT01823042October 201219 February 2015The 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, ChinaRecruiting18 Years75 YearsBoth100N/AChina
458EUCTR2011-006064-43-DE27/09/201222 May 2017Study 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 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
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not applicable
Current Sponsor code: Allogenic eASCs
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 5000000 -
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intralesional use
TiGenix S.A.U.Not RecruitingFemale: yes
Male: yes
208Phase 3France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy
459EUCTR2012-000529-31-GB27/09/201228 February 2019A 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 DiseaseModerate 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]
Product Name: AMG 181
Product Code: AMG 181
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 181
Current Sponsor code: AMG 181
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Amgen IncNot Recruiting Female: yes
Male: yes
252Phase 2France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom
460EUCTR2012-002702-51-DK24/09/20125 February 2018Discontinuation 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 ITPatients 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Trade Name: Remsima
Product Name: Remsima
Pharmaceutical Form: Concentrate for solution for infusion
Department of medical gastroenterology S, Odense University HospitalAuthorisedFemale: yes
Male: yes
136Phase 4Finland;Denmark;Norway;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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461JPRN-UMIN0000152972012/09/1923 April 2019The 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 administrationpatient 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 HospitalRecruiting20years-old70years-oldMale and Female54Phase 2Japan
462NCT01632462September 201219 February 2015A 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 UniversityRecruiting5 Years17 YearsBoth30Phase 4Italy
463NCT03079700August 1, 201216 December 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 AarhusNot recruiting18 Years70 YearsMale1N/A
464EUCTR2011-005846-36-DK31/07/20127 April 2015Bloodflow 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) - STENOSISCrohns 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 Level: PT Classification code 10059696 Term: Scan with contrast System Organ Class: 10022891 - Investigations
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 10028049 Term: MRI System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT Classification code 10045434 Term: Ultrasound scan System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: sulphur hexafluoride
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration unit: µl/ml microlitre(s)/millilitre
Concentration type: equal
Concentration number: 8-
Gastroenterology MIDTNot RecruitingFemale: yes
Male: yes
Denmark
465EUCTR2011-005886-19-DK31/07/20127 April 2015Correlation 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) - CONTRASTCrohns 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 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: PT 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: sulphur hexafluoride
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration unit: µl/ml microlitre(s)/millilitre
Concentration type: equal
Concentration number: 8-
Gastroenterology MIDTNot RecruitingFemale: yes
Male: yes
Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
466NCT01570348July 201211 March 2019Crohn's Allogeneic Transplant StudyAllogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 StudyCrohn DiseaseProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Drug: Mycophenolic Acid;Other: Quality-of-Life Assessment;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Institutes of Health (NIH)Not recruiting18 Years60 YearsAll2Phase 2United States
467NCT01576471July 201216 December 2017Efficacy 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.Not recruiting18 Years65 YearsAll250Phase 2United States
468NCT01629628July 201219 February 2015Adalimumab for the Management of Post-operative Crohn's Disease (CD)An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD PatientsCrohn DiseaseDrug: Adalimumab;Drug: 6 MercaptopurineTel-Aviv Sourasky Medical CenterAbbottNot recruiting18 Years70 YearsBoth100Phase 3Israel
469NCT01659762July 201224 October 2016A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease.Crohn's DiseaseBiological: autologous mesenchymal stromal cellEmory UniversityAtlanta Clinical and Translational Science Institute;Atlanta Clinical and Translational Science InstituteNot recruiting18 Years65 YearsBoth16Phase 1United States
470NCT00692939June 26, 201226 August 2019Autologous 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 SzabolcsRecruiting10 Years60 YearsAll20Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
471EUCTR2011-003038-14-NL21/06/20123 July 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 - TAILORIXLuminal 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
Pharmaceutical Form: Suspension for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: INFLIXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
GETAIDAuthorisedFemale: yes
Male: yes
120Netherlands
472EUCTR2011-004820-37-ES13/06/201226 June 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 patientsPhase 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 patientsPerianal 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)
Pharmaceutical Form: Rectal solution
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
Concentration unit: % percent
Concentration type: equal
Concentration number: 100-
Fundación FISEVIAuthorisedFemale: yes
Male: yes
Phase 2Spain
473EUCTR2012-000729-28-ES13/06/201226 June 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 ACTIVITYInvestigation 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: /
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ÁCIDO GADOBÉNICO
CAS Number: 113662-23-0
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number: 0.1-
Genentech, Inc.AuthorisedFemale: yes
Male: yes
54Belgium;France;Spain;United States
474EUCTR2009-017998-37-BE08/06/20122 May 2016Scintigraphic 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 Level: HLT Classification code 10039078 Term: Rheumatoid arthropathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab pegol
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Product Name: 99mTc-S-HYNIC Certolizumab pegol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Ghent University HospitalAuthorisedFemale: yes
Male: yes
Belgium
475EUCTR2011-001754-28-DE05/06/20128 August 2016A 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 DISEASECrohn'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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Pfizer Inc.235 East 42nd Street, New York, NY 10017, USANot 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_
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Last_Refreshed_
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476EUCTR2011-006127-38-ES05/06/201226 June 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 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)
Pharmaceutical Form: Rectal solution
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
Concentration unit: % percent
Concentration type: equal
Concentration number: 100-
Fundación FISEVIAuthorisedFemale: yes
Male: yes
Phase 2Spain
477JPRN-UMIN0000078062012/06/012 April 2019The feasibility study of accelated infliximab infusion during maintenance phasepatient 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 HospitalNot RecruitingNot applicableNot applicableMale and Female54Phase 2Japan
478JPRN-UMIN0000081992012/06/012 April 2019The 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 UniversityNot Recruiting12years-old85years-oldMale and Female40Not selectedJapan
479NCT01181765June 201219 February 2015The 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.Not recruiting18 YearsN/ABoth1Phase 4Canada
480NCT01442025June 201224 August 2015Study 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 DigestivesNot recruiting18 YearsN/ABoth121Phase 4France
No.TrialIDDate_
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481NCT01545050June 201211 June 2018Dose 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-945429Vitaeris INCNot recruiting18 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
482NCT01564823June 201230 March 2015Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s DiseaseAdalimumab on Preventing Postoperative Recurrence of Crohn's DiseaseCrohn´s DiseaseDrug: Metronidazole;Drug: Azathioprine;Drug: AdalimumabGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaEffice Servicios Para la Investigacion S.L.Not recruiting18 YearsN/ABoth86Phase 3Spain
483NCT01624376June 201219 February 2015Randomized, 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 AGNot recruiting18 Years65 YearsBoth18Phase 2Switzerland
484NCT02445547June 201216 December 2017Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's DiseaseUmbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical TrialCrohn DiseaseOther: UC-MSCs by peripheral intravenous infusion;Drug: received hormone maintenance therapyFuzhou General HospitalShaanxi Provincial People's HospitalNot recruiting18 Years70 YearsAll82Phase 1/Phase 2China
485JPRN-UMIN0000096312012/05/022 April 2019Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled studyCrohn'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 UniversityRecruiting16years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
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486JPRN-UMIN0000080432012/05/0122 July 2019The 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 vaccinationCrohn'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 Medicine Division of Gastroenterology and HepatologyNot Recruiting16years-old60years-oldMale and Female150Phase 4Japan
487NCT01387594May 201216 December 2017Evaluate 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 punctureShireNot recruiting18 Years75 YearsAll49Phase 1Austria;Belgium;France;Germany;Netherlands
488NCT01369667April 201224 August 2015Vitamin D Supplementation in Adult Crohn's DiseaseVitamin D and Immunomodulation: Effects in Crohn's DiseaseCrohn's DiseaseDietary Supplement: Vitamin D3;Other: PlaceboUniversity of Dublin, Trinity CollegeQueen Mary University of LondonNot recruiting18 Years75 YearsBoth117Phase 4Ireland
489NCT01470599April 201216 December 2017A 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-690,550PfizerNot recruiting18 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
490NCT01556672April 201211 July 2016Adalimumab-psoriasis and Small Bowel LesionsOpen-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With AdalimumabPlaque Psoriasis;Crohn's DiseaseDrug: Adalimumab;Device: Capsule endoscopyInnovaderm Research Inc.Abbott;AbbottNot recruiting18 Years80 YearsBoth100Phase 4Canada
No.TrialIDDate_
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491NCT01877577April 201219 February 2015Supplementation 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 FranciscoNot recruiting18 YearsN/ABoth30N/AUnited States
492EUCTR2011-005966-39-BE08/03/20127 October 2014Therapeutic 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 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 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: mesenchymal stem cells
Product Code: MSC
Pharmaceutical Form: Infusion
CHU-ULgAuthorisedFemale: yes
Male: yes
20Belgium
493NCT01393899March 201219 October 2017The 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-690,550PfizerNot recruiting18 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
494NCT01540292March 201219 February 2015Mesenchymal 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 LiegeRecruiting18 Years75 YearsBoth20Phase 1/Phase 2Belgium
495NCT01580670March 201215 July 2019Clinical 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 CorporationNot recruiting6 Years17 YearsAll14Phase 3Japan
No.TrialIDDate_
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PhaseCountries
496NCT01647412March 201220 April 2015Growth 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 UniversityNot recruiting10 Years17 YearsBoth0Phase 2United States
497NCT01957423March 201219 February 2015Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.Crohn's DiseaseDietary Supplement: Whey protein;Dietary Supplement: Soy proteinUniversity of Campinas, BrazilFundação de Amparo à Pesquisa do Estado de São PauloNot recruitingN/AN/ABoth41N/ABrazil
498NCT02450513March 201213 June 2016Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic StudyAdalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic StudyCrohn's DiseaseDrug: AdalimumabUniversitaire Ziekenhuizen LeuvenRecruiting18 Years65 YearsBoth30N/ABelgium
499EUCTR2011-002517-11-DE22/02/20125 November 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 - OlokizumabModerate 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: olokizumab
CAS Number: 1007223-17-7
Current Sponsor code: CDP6038
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
UCB BIOSCIENCES GmbHNot RecruitingFemale: yes
Male: yes
96Germany;Hungary;Czech Republic;Serbia
500JPRN-UMIN0000068822012/02/012 April 2019Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab TherapyCrohn's diseaseAdalimumab therapy (40 mg/dose, every other week) combined with Granulocyte/ Monocyte Apheresis (GMA), once weekly for 5 comsecutive weeks. If responses are noted, GMA is applied for another 5 sessions (once weekly).Department of Lower Gastroenterology, Hyogo College of MedicineHyogo College of Medicine (Hyogo, Japan), Osaka City Univ. (Osaka, Japan), Osaka Medical College (Osaka, Japan), Kyoto Univ. (Kyoto, Japan), Shiga University of Medical Science (Shiga, Japan)Not Recruiting15years-oldNot applicableMale and Female20Phase 4Japan
No.TrialIDDate_
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501JPRN-UMIN0000073432012/02/0110 September 2019The 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 patientsCrohn'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)Not Recruiting20years-oldNot applicableMale and Female90Not applicableJapan
502NCT01514240February 201219 October 2017Phase 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 tabletsAstraZenecaNot recruiting15 Years130 YearsAll123Phase 3Japan
503NCT02399683February 201228 November 2016Immune 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 AarhusNot recruiting18 Years70 YearsMale1N/A
504EUCTR2011-005678-47-IT19/01/201218 March 2013A 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 2CROHN'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
Pharmaceutical Form: Modified-release capsule, hard
Current Sponsor code: GED-0301
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Modified-release capsule, hard
Route of administration of the placebo: Oral use
GIULIANINot RecruitingFemale: yes
Male: yes
Phase 2Italy
505EUCTR2011-003966-34-ES10/01/201210 March 2014Biomarkers 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 applicableCrohn'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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 40-160
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)Not RecruitingFemale: yes
Male: yes
180Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
506EUCTR2011-002817-12-GR09/01/201228 October 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 DiseaseModerately-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
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1605786A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
GlaxoSmithKline Research and Development LimitedNot RecruitingFemale: yes
Male: yes
900Argentina;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;China;Netherlands;South Africa;Australia;Denmark;France;Italy;Switzerland;Russian Federation;Israel;Spain;Greece;Slovakia;Hong Kong;Taiwan;Estonia;Portugal;United States;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden
507JPRN-UMIN0000068892012/01/012 April 2019Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab TherapyCrohn'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 MedicineNot Recruiting16years-old75years-oldMale and Female50Phase 4Japan
508JPRN-UMIN0000075142012/01/012 April 2019Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease RecurrenceCrohn'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 Medicine Department of GastroenterologyNot Recruiting20years-oldNot applicableMale and Female25Phase 2Japan
509EUCTR2011-000885-36-ES26/12/201116 February 2015Adalimub 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 - APPRECIACompare 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Current Sponsor code: NA
Other descriptive name: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Trade Name: Imurel
Product Name: Imurel
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Azatioprina
CAS Number: 6336-41-0
Other descriptive name: Imurel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Flagyl
Product Name: Flagyl
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Metronidazol
CAS Number: 99616-64-5
Other descriptive name: Flagyl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
GETECCUNot RecruitingFemale: yes
Male: yes
Spain
510EUCTR2011-003966-34-BE06/12/201121 August 2017Biomarkers 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 immunosuppressantsCrohn'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
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 40-160
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)Not RecruitingFemale: yes
Male: yes
180Phase 3Spain;Belgium
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
511NCT01438151December 201119 October 2017Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's DiseaseAssociation of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's DiseaseCrohn's DiseaseDrug: RemicadeShradha AgarwalPrometheus LaboratoriesNot recruiting7 YearsN/AAll11N/AUnited States
512NCT01453946December 201119 October 2017Safety 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 CompanyNot recruiting5 Years17 YearsAll55Phase 3Italy;Poland;United States;Canada;Germany
513NCT01466374December 201128 September 2015Induction 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 SquibbNot recruiting18 YearsN/ABoth121Phase 2United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa
514NCT01496053December 201128 April 2015Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective StudyUlcerative Colitis;Crohn's Disease;Inflammatory Bowel DiseaseDietary Supplement: AndoSan;Dietary Supplement: Sugar ExtractOslo University HospitalImmunoPharmaRecruiting18 Years60 YearsBoth100Phase 2/Phase 3Norway
515NCT01505855December 201119 February 2015Efficacy Study of Pneumococcal Vaccination in Crohn's DiseaseSerological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter StudyCrohn's DiseaseDrug: 23-valent polysaccharide pneumococcal vaccineKyunghee University Medical CenterWonju Severance Christian Hospital;Seoul National University Hospital;Asan Medical Center;Soonchunhyang University Hospital;Ewha Womans University;Kosin University Gospel Hospital;Chung-Ang University Hospital;Inje University;The Catholic University of Korea;Keimyung University Dongsan Medical Center;Korea University;Wonkwang University;Severance Hospital;Konkuk University HospitalNot recruiting18 YearsN/ABoth197Phase 4Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
516NCT01792388December 201119 February 2015Vitd and Barrier Function in IBDVitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in RemissionCrohn's DiseaseDietary Supplement: Vitamin D;Dietary Supplement: Soya Bean oilUniversity of Dublin, Trinity CollegeUniversity of Calgary;Queen Mary University of LondonNot recruiting18 Years70 YearsBoth30Phase 4Ireland
517NCT01536418November 11, 20115 February 2018An 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: GSK1605786AGlaxoSmithKlineNot recruiting18 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
518NCT01218360November 201130 March 2015Observational 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.Not recruiting18 Years65 YearsBoth71N/AGreece
519NCT01434693November 201119 October 2017Safety 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.Not recruiting18 Years55 YearsAll36Phase 1United States
520NCT01442363November 201119 February 2015A 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 LaboratoriesNot recruiting18 YearsN/ABoth8Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
521NCT01444092November 201119 October 2017Safety 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 CompanyNot recruiting5 Years17 YearsAll123Phase 3United States;Canada;Germany;Italy;Poland
522NCT01540942November 201119 February 2015Impact 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, ChinaNot recruiting18 Years75 YearsBoth91N/AChina
523JPRN-UMIN0000062322011/10/012 April 2019Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximabCrohn'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 UniversityNot Recruiting15years-old70years-oldMale and Female40Not selectedJapan
524NCT01393626October 201116 December 2017A 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-690,550PfizerNot recruiting18 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
525NCT01433432October 201119 February 2015Open 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 GTCNot recruiting18 Years75 YearsBoth0Phase 2Israel
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
526NCT01489943September 19, 201116 December 2017A 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 mgGlaxoSmithKlineNot recruiting18 Years55 YearsAll24Phase 1United States
527EUCTR2010-022760-12-DE13/09/20115 March 2018A 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 - IMUNITIModerately 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: N/A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: N/A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 77-104
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Janssen-Cilag International N.V.AuthorisedFemale: yes
Male: yes
1310Phase 3New Zealand;Japan;Germany;Iceland;Bulgaria;Croatia;Belgium;Brazil;Canada;European Union;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;Italy;Russian Federation;Israel;Ireland;Spain;Serbia;United States
528NCT01369355September 13, 201122 October 2019A 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, LLCNot recruiting18 Years99 YearsAll1282Phase 3Spain;United Kingdom;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;United States;Czech Republic
529JPRN-UMIN0000056892011/09/012 April 2019GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trialCrohn'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 HospitalNot Recruiting12years-old75years-oldMale and Female60Not applicableJapan
530NCT01388933September 201119 February 2015A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's DiseaseA Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's DiseaseCrohn's DiseaseDrug: TU-100;Drug: Matching PlaceboTsumura USAINC ResearchNot recruiting18 Years75 YearsBoth79Phase 2United States
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
531EUCTR2010-022759-42-DE29/08/201116 November 2015A 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 2Moderately 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: N/A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Janssen-Cilag International N.V.Not 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
532EUCTR2010-022758-18-DE24/08/201126 October 2015Study 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 1Moderately 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: N/A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Janssen-Cilag International N.V.Not RecruitingFemale: yes
Male: yes
703Phase 3Korea, Republic of;Japan;New Zealand;Iceland;Germany;South Africa;Australia;Denmark;Brazil;Belgium;Canada;European Union;Czech Republic;Hungary;United Kingdom;Italy;Israel;Austria;Ireland;Spain;United States;Serbia
533EUCTR2010-023797-39-GB12/08/201128 January 2013TREATMENT 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
Trade Name: Iron sulphate 200mg coated tablets
Product Name: Ferrous sulphate
Product Code: Ferrous sulphate
Pharmaceutical Form: Tablet
INN or Proposed INN: Iron sulphate
CAS Number: 7720-78-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: CosmoFer
Product Name: CosmoFer 50mg/ml solution for infusion or injection
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: iron(III)- hydroxide dextran complex
CAS Number: 9004-66-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Barts Health NHS TrustAuthorisedFemale: yes
Male: yes
Phase 4United Kingdom
534NCT01352221August 201116 December 2017Safety 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 TherapeuticsNot recruiting18 YearsN/AAll128Phase 3Austria;United Kingdom
535NCT02619552August 201126 August 2019Impact of Medical Treatment on Sexual Function in Patients With Crohn's DiseaseImpact of Medical Treatment on Sexual Function in Patients With Crohn's DiseaseCrohn's Disease;IBDDrug: Anti-TNF;Drug: SteroidsUniversity of Maryland, BaltimoreVanderbilt University;Milton S. Hershey Medical Center;Mercy Medical CenterNot recruiting18 YearsN/AAll50Phase 1United States
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
536EUCTR2010-022215-19-GB21/07/20113 December 2012Combined 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’sImpaired 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution
CAS Number: 67763-96-6
Other descriptive name: Recombinant human Insulin-like Growth Factor
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Trade Name: NutropinAq®
Product Name: NutropinAq 10mg/2ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin(rhGH)
CAS Number: 12629-01-5
Other descriptive name: recombinant growth hormone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-1
Greater Glasgow & Clyde NHSAuthorisedFemale: yes
Male: yes
24United Kingdom
537EUCTR2011-002821-24-IT21/07/201125 March 2013Study 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/006/2011Treatment 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 380-420
ALFA WASSERMANNNot RecruitingFemale: yes
Male: yes
Italy
538EUCTR2011-002640-27-IT14/07/201128 October 2013A 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 STUDYACTIVE 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
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/g milligram(s)/gram
Concentration type: up to
Concentration number: 160-
GIULIANINot RecruitingFemale: yes
Male: yes
Phase 2Germany;Italy
539JPRN-UMIN0000059702011/07/012 April 2019Investigation 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 SchoolRecruiting20years-oldNot applicableMale and Female100Not selectedJapan
540NCT01298492July 1, 201116 December 2017A 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-00547659ShireNot recruiting18 Years75 YearsAll268Phase 2United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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541EUCTR2011-002061-38-BE29/06/201121 August 2017Treating 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). - TAXIT2) 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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Katholieke Universiteit LeuvenNot RecruitingFemale: yes
Male: yes
Phase 4Belgium
542JPRN-UMIN0000052512011/06/012 April 2019A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximabCrohn'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 UniversityNot Recruiting16years-oldNot applicableMale and Female14Not selectedJapan
543NCT01345318June 201116 December 2017B0151005 Open-Label Extension StudyA Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)Crohn's DiseaseBiological: PF-04236921PfizerNot recruitingN/AN/AAll191Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;New Zealand;Switzerland;United Kingdom
544NCT01582568June 201114 March 2016EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB TreatmentEUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB TreatmentCrohns DiseaseDrug: CertolizumabBaylor College of MedicineUCB PharmaNot recruiting18 Years70 YearsBoth1Phase 4United States
545EUCTR2011-000854-44-SE02/05/201117 November 2014A 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 DiseaseCrohn'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
Pharmaceutical Form: Film-coated tablet
CAS Number: 894404-71-8
Current Sponsor code: TRK-170
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: TRK-170
Product Code: TRK-170
Pharmaceutical Form: Film-coated tablet
CAS Number: 894404-71-8
Current Sponsor code: TRK-170
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Toray Industries IncNot RecruitingFemale: yes
Male: yes
609Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia
No.TrialIDDate_
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Last_Refreshed_
on
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546ChiCTR-TRC-110013212011-05-0118 April 2017Effect 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 DiseaseCrohn'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 UniversityNot Recruiting1475Bothcontrol group:30;?-3 Fat group:30;Post-marketChina
547NCT01346826May 20118 August 2016Safety 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 CenterNot recruiting16 Years80 YearsBoth145Phase 4Korea, Republic of
548NCT01276509April 6, 201116 December 2017Study 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 injectionShireNot recruiting18 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
549NCT01338740April 201119 February 2015Switching From Adalimumab to InfliximabProspective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to AdalimumabCrohn's DiseaseDrug: Adalimumab and InfliximabUniversity Hospital, GhentAbbottRecruiting18 Years75 YearsBoth40N/ABelgium
550NCT01341808April 201119 February 2015Immunogenicity 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 CenterNot recruiting18 Years40 YearsBoth493Phase 4Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
551NCT01345799April 201119 February 2015A 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, IncNot recruiting18 Years50 YearsBoth123Phase 2Belgium;Bulgaria;Czech Republic;France;Hungary;Latvia;Netherlands;Norway;Poland;Romania;Serbia;Sweden;Ukraine
552NCT02504255April 20113 August 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 LyonNot recruiting18 YearsN/ABoth144Phase 3France
553EUCTR2010-023347-14-BE02/03/201117 February 2014Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LAR An open pilot studyTreatment of Crohn’s disease-associated refractory diarrhoea with octreotide LAR An open pilot studyCrohn Disease refractory diarrhoea
MedDRA version: 12.1 Level: LLT Classification code 10066533 Term: Diarrhea recurrent
Trade Name: Sandostatine
Product Name: sandostatine
Pharmaceutical Form: Injection*
Trade Name: Sandostatine
Product Name: sandostatine
Pharmaceutical Form: Injection*
Gastroenterology CHC LiegeAuthorisedFemale: yes
Male: yes
Belgium
554JPRN-UMIN0000051462011/03/012 April 2019Study 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 UniversityNot Recruiting15years-oldNot applicableMale and Female200Phase 4Japan
555NCT01258205February 28, 201116 December 2017Multiple 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 139AllerganNot recruiting18 Years55 YearsAll48Phase 1United States;Australia
No.TrialIDDate_
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556EUCTR2010-022383-12-NL16/02/201112 May 2014A 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 DiseaseSubjects 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: GSK1605786A
CAS Number: na
Current Sponsor code: GSK1605786A
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LimitedNot 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
557EUCTR2010-024528-12-DK14/02/201122 July 2013Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULTKontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULTMorbus 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
Pharmaceutical Form: Powder for solution for injection
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 45-
Henning GlerupNot RecruitingFemale: yes
Male: yes
5Denmark
558EUCTR2010-022384-35-DE02/02/201114 April 2014A 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 studySubjects 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
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1605786A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
GlaxoSmithKline Research & Development LtdNot 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
559NCT01203631February 20118 August 2016Safety 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, LLCNot recruiting18 Years75 YearsBoth78Phase 2United States;Belgium;Canada;France;Hungary;Israel;Poland;Russian Federation
560NCT01287897February 201119 October 2017A 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 injectionPfizerNot recruiting18 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_
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561NCT01290042February 201123 March 2015Study 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 181AmgenNot recruiting18 Years65 YearsBoth43Phase 1United States;Australia
562NCT01291810February 201119 February 2015Clinical 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: WFINeovacsNot recruiting18 Years65 YearsBoth66Phase 2Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania
563EUCTR2010-019973-13-DE14/01/20113 September 2012A 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 diseaseTreatment 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 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Product Code: QAX576
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: QAX576
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Novartis Pharma AGNot RecruitingFemale: yes
Male: yes
23Phase 2Germany;Switzerland
564EUCTR2010-019996-32-BE12/01/201121 August 2017A 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 DiseaseCrohn’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
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not assigned yet
Current Sponsor code: TNFa-Kinoid or TNFa-K or Kinoid
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use
Neovacs SANot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
565EUCTR2010-020836-21-BE07/01/201121 August 2017A 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 diseaseCrohn’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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC142-0002
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Novo Nordisk A/SNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Hungary;European Union;Canada;Poland;Belgium;Israel;Russian Federation
No.TrialIDDate_
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566EUCTR2010-022017-26-GB07/01/201128 February 2019A 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 diseaseCrohn's disease
MedDRA version: 12. Level: LLT Classification code 10013099 Term: Disease Crohns
Product Name: Prednisolone
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: Prednisolone
CAS Number: 125-02-0
Concentration unit: mg milligram(s)
Concentration type: equal
Central Manchester University Hospitals Foundation TrustNot Recruiting Female: yes
Male: yes
27Phase 2United Kingdom
567EUCTR2010-022382-10-GB06/01/20112 October 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 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 DiseaseSubjects 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
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1605786A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
GlaxoSmithKline Research & Development LtdAuthorisedFemale: yes
Male: yes
600Hungary;Germany;Netherlands;Norway;France;Italy;Austria;Sweden;Australia;United Kingdom;Czech Republic;Canada;Belgium;Denmark;Spain;Japan;United States
568JPRN-UMIN0000070472011/01/012 April 2019Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's diseaseCrohn'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 HepatologyRecruiting12years-old75years-oldMale and Female40Not applicableJapan
569NCT01245088January 201119 February 2015Chondroitin 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 CenterNot recruiting18 Years80 YearsBoth0Phase 1/Phase 2United States
570NCT01275508January 201119 February 2015Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the GutProspective, Monocentric, Open-label, Clinical Phase 1 Study to Demonstrate the Safety and Tolerability of FITC-Adalimumab After Single Topical Administration to the Intestinal Mucosa During Endomicroscopy in Patients With Crohn's DiseaseCrohn's DiseaseDrug: FITC-AdalimumabUniversity of Erlangen-Nürnberg Medical SchoolAbbottNot recruiting18 Years70 YearsBoth25Phase 1/Phase 2Germany
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
571NCT01316601January 20118 June 2015A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's DiseaseCrohn's DiseaseDrug: QAX567Gerhard RoglerNovartis PharmaceuticalsNot recruiting18 YearsN/ABoth3Phase 2Switzerland
572EUCTR2011-003742-40-DE23 February 2015A 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, InclusiveCrohn'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
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
AstraZeneca ABNot RecruitingFemale: yes
Male: yes
50United States;Canada;Poland;Germany;Italy
573EUCTR2011-003743-22-DE10 July 2015A 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, InclusiveCrohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Entocort® Kapseln
Product Name: budesonide
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: budesonide
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
AstraZeneca ABNot RecruitingFemale: yes
Male: yes
110United States;Canada;Poland;Germany;Italy
574NCT01277666December 20, 201016 December 2017A 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: PlaceboGlaxoSmithKlineNot recruiting18 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
575NCT01199302December 201011 May 2015Safety 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 827AmgenNot recruitingN/AN/ABoth67Phase 2United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
576NCT01266785December 201020 May 2019Infliximab, Regulatory T Cells, IL2 and Crohn's DiseaseAnalysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's DiseaseCrohn's DiseaseDrug: InfliximabOregon Health and Science UniversityCentocor, Inc.Not recruiting18 Years70 YearsAll0N/AUnited States
577NCT01094613November 201019 February 2015Multicenter 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 GTCNot recruiting18 Years75 YearsBoth70Phase 1/Phase 2Israel
578NCT01224171November 201019 October 2017Study 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.Not recruiting18 Years80 YearsAll416Phase 3United States;Canada;Puerto Rico
579EUCTR2006-000720-13-DE27/10/201016 November 2015Study 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 diseaseInduction 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
Pharmaceutical Form: Oral suspension
Current Sponsor code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 17-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Pharmaceutical Form: Oral suspension
Current Sponsor code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 167-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Pharmaceutical Form: Oral suspension
Current Sponsor code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
400Phase 2Czech Republic;Denmark;Austria;Germany;Switzerland
580JPRN-UMIN0000057612010/10/272 April 2019The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to InfliximabCrohn'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 WatanabeNot RecruitingNot applicableNot applicableMale and Female50Not selectedJapan
No.TrialIDDate_
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581JPRN-UMIN0000057622010/10/272 April 2019The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's DiseaseCrohn'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 WatanabeNot RecruitingNot applicableNot applicableMale and Female40Not selectedJapan
582NCT01111292October 201019 October 2017Inositol 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)Not recruiting18 YearsN/AAll5Phase 1/Phase 2United States
583NCT01203254October 201019 February 2015Colesevelam 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 BeigelNot recruiting18 Years65 YearsBoth34Phase 4Germany
584NCT01231217October 201019 February 2015Green Tea in Crohn's DiseaseCrohn's DiseaseOther: Green tea (Camellia sinensis);Other: CoffeeUniversity Hospital HeidelbergRecruiting18 YearsN/ABoth80N/AGermany
585EUCTR2010-020137-10-GB20/09/201030 April 2019Efficacy 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 - CALMCrohn'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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Decortin 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Decortin 20 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
AbbVie Deutschland GmbH & Co. KGNot Recruiting Female: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
No.TrialIDDate_
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586NCT01187459September 201019 February 2015Vitamin D in Pediatric Crohn's DiseaseVitamin D in Pediatric Crohn's DiseaseVitamin D DeficiencyDietary Supplement: Vitamin DUniversity of British ColumbiaMcMaster UniversityNot recruiting8 Years18 YearsBoth87Phase 4Canada
587NCT01215890September 201019 February 2015Risedronate 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 AlbertaNot recruiting18 YearsN/ABothPhase 4Canada
588NCT01233570September 201019 February 2015Topical 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 AberdeenNot recruiting12 YearsN/ABoth20Phase 2United Kingdom
589NCT01233960September 201016 December 2017Evaluation 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 International SàrlNot recruiting18 Years70 YearsAll120Phase 3United States;Australia;New Zealand
590EUCTR2010-018431-18-DE23/08/201016 February 2015A 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 - PREVENTCrohn’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
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: INFLIXIMAB
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Janssen Biologics B.V.Not RecruitingFemale: yes
Male: yes
290Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollement
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591NCT01155362August 20104 March 2019A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's DiseaseA Phase 2a, Randomized, Double Blind, Placebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's DiseaseCrohn's DiseaseBiological: Human Placenta-Derived Cells PDA001 Intravenous Infusion;Drug: Vehice ControlCelularity IncorporatedCelgene CorporationNot recruiting18 Years75 YearsAll50Phase 2United States
592NCT01190410August 201023 July 2018Extension 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 PharmaNot recruiting6 Years17 YearsAll16Phase 2United States;Canada;Australia
593NCT01261286August 201019 February 2015Drug-Disease Interaction in Crohn's DiseasePharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease PatientsCrohn's DiseaseDrug: verapamilUniversity of AlbertaNot recruiting18 Years65 YearsBothPhase 1Canada
594NCT01611805July 22, 201016 December 2017Japanese 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 PlaceboGlaxoSmithKlineNot recruiting20 Years55 YearsMale30Phase 1Australia
595NCT01150890July 201025 May 2015AMG 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: PlaceboAmgenNot recruiting18 Years65 YearsBoth130Phase 2United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain
No.TrialIDDate_
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596EUCTR2009-015680-14-NL18/05/201016 February 2015Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn’s Disease - allo bmMSCs CD fistulaAllogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn’s Disease - allo bmMSCs CD fistulasingle 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
Pharmaceutical Form: Injection*
Leiden University Medical CenterNot RecruitingFemale: yes
Male: yes
Netherlands
597NCT01114607May 5, 201016 December 2017A 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 EGlaxoSmithKlineNot recruiting18 Years55 YearsAll24Phase 1United States
598NCT00737932May 201030 March 2015Laquinimod 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 IndustriesNot recruiting18 Years75 YearsBoth180Phase 2Belgium;France;Israel;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom
599NCT00988832February 201019 October 2017An 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.Not recruiting18 YearsN/AAll380N/AUnited Kingdom
600NCT01037322January 201019 February 2015Cannabidiol for Inflammatory Bowel DiseaseUse of Cannabidiol for the Treatment of Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: cannabidiol;Drug: placebo in dropsMeir Medical CenterNot recruiting20 Years80 YearsBoth20Phase 1/Phase 2Israel
No.TrialIDDate_
enrollement
Last_Refreshed_
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601NCT01040910January 201019 February 2015Cannabis 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 CenterRecruiting20 Years70 YearsBoth20Phase 1/Phase 2Israel
602NCT01046773January 201019 February 2018Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's DiseaseVitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's DiseaseCrohn's Disease;Vitamin D DeficiencyDrug: CholecalciferolUniversity of California, Los AngelesThe Broad FoundationNot recruiting8 Years18 YearsAll3Phase 1United States
603NCT01053559January 201019 February 2015Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule EndoscopyOpen Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule EndoscopyCrohn's DiseaseDrug: certolizumab pegolShafran Gastroenterology CenterUCB PharmaNot recruiting18 Years70 YearsBoth15N/AUnited States
604NCT01090817January 201029 June 2015An Australian Study of Mesenchymal Stromal Cells for Crohn's DiseaseA Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's DiseaseCrohn DiseaseDrug: Mesenchymal stromal cells (MSC) for infusionR.P.HerrmannThe Queen Elizabeth Hospital;Concord Hospital;Sir Charles Gairdner Hospital;The AlfredNot recruiting18 Years55 YearsBoth21Phase 2Australia
605NCT01288053January 201020 August 2018Non-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 UniversityNot recruiting18 Years45 YearsAll9Phase 1/Phase 2United States
No.TrialIDDate_
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606NCT01548014January 201019 February 2015The 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 CenterRecruiting13 Years17 YearsBoth1Phase 3Korea, Republic of
607JPRN-UMIN0000102932009/12/192 April 2019Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapyCrohn's diseaseInfliximab maintenance therapy for 48 weeks in, Racol daily nutritional interventions during the study period as a target intake of 800kcal per day, in the implementation group nutrition therapy is used in conjunction with a diet and Racol.
In the group of non-nutritional therapy is carried out aggressive nutritional intervention is not performed, and only the normal diet
Graduate School of Medical Sciences, Kyushu UniversityOita Red Cross Hospital Takano HospitalRecruiting20years-oldNot applicableMale and Female80Not applicableJapan
608EUCTR2008-005237-30-NL01/12/20097 December 2015A 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 - DEVELOPPediatric 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remsima and Inflectra
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Janssen Biologics B.V.AuthorisedFemale: yes
Male: yes
6000United States;Canada;Netherlands;Sweden
609NCT01024647December 200919 February 2015Optimizing Cimzia in Crohn's PatientsOptimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction TherapyCrohn's DiseaseBiological: certolizumab pegolAtlanta Gastroenterology AssociatesUCB PharmaRecruiting18 YearsN/ABoth50Phase 4United States
610EUCTR2009-011621-14-AT12/11/200919 March 2012A 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 disease - 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’s disease - A2202E1Moderate 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not available
CAS Number: None
Current Sponsor code: AIN457
Other descriptive name: None
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
72Germany;Austria
No.TrialIDDate_
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611JPRN-UMIN0000027962009/11/012 April 2019Effect 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 UniversityRecruiting16years-old65years-oldMale and Female50Phase 2Japan
612NCT01015391November 200919 February 2015Efficacy 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, ChinaRecruiting18 YearsN/ABoth100N/AChina
613EUCTR2008-006957-42-DE30/10/200911 March 2013Double-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 diseaseInduction 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
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany
614EUCTR2009-011220-62-NL26/10/200919 March 2012A 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 study1. 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
Pharmaceutical Form: Tablet
INN or Proposed INN: mesalazine
CAS Number: 65-49-6
Other descriptive name: AMINOSALICYLIC ACID
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 3000-3200
University Medical Center UtrechtNot RecruitingFemale: yes
Male: yes
Netherlands
615NCT00989573October 200919 February 2015A 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.Not recruiting18 Years64 YearsBoth191Phase 2/Phase 3Japan;Korea, Republic of
No.TrialIDDate_
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616NCT01661257October 200919 February 2015Expression 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 CenterNot recruiting13 Years17 YearsBoth20Phase 3Korea, Republic of
617NCT00999115September 200919 February 2015Allogenic 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 PazNot recruiting18 YearsN/AFemale10Phase 1/Phase 2Spain
618NCT02322008September 200919 February 2015Anti-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, SkiveNot recruiting18 YearsN/ABoth1035N/A
619EUCTR2009-013348-35-NL04/08/200919 March 2012(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 diseasePatients 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 Level: LLT Classification code 10011401 Term: Crohn's disease
MedDRA version: 9.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon)
Trade Name: Chenofalk
Product Name: Chenofalk
Product Code: RVG 07151
Pharmaceutical Form: Capsule*
INN or Proposed INN: CHENODEOXYCHOLIC ACID
CAS Number: 474259
Other descriptive name: Chenodiol
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 15-
University Medical Center UtrechtNot RecruitingFemale: yes
Male: yes
Netherlands
620NCT00367705August 200919 February 2015VSL#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 OrganizationNot recruiting6 Years18 YearsBoth300Phase 4Israel
No.TrialIDDate_
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621NCT01012570August 200919 February 2015The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) PatientsCrohn's DiseaseDrug: Application of AdalimumabGerhard RoglerNot recruiting18 Years65 YearsBoth34Phase 2Switzerland
622EUCTR2009-011763-37-IT22/07/200928 August 2012THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB IN CROHN`S DISEASE - NDTHE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB IN CROHN`S DISEASE - NDCrohn`s Disease
MedDRA version: 9.1 Level: LLT Classification code 10038283 Term: Regional enteritis of small intestine with large intestine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
ISTITUTO CLINICO HUMANITASNot RecruitingFemale: yes
Male: yes
Italy
623JPRN-UMIN0000020742009/07/012 April 2019Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaLCrohn'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 MedicineNot Recruiting20years-old65years-oldMale and Female45Phase 2Japan
624NCT00944736July 200919 February 2015Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's DiseaseEffect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in RemissionCrohn's DiseaseDietary Supplement: VSL#3;Dietary Supplement: PlaceboChildren's Mercy Hospital Kansas CityVSL PharmaceuticalsNot recruiting11 Years17 YearsBoth12Phase 3United States
625NCT00950105July 200919 February 2015Single 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 PharmaceuticalsNot recruiting18 Years55 YearsBoth30Phase 1United States
No.TrialIDDate_
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626NCT00972218July 200926 September 2016Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel DiseaseEfficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's DiseaseSpondyloarthritis;Crohn's DiseaseBiological: AdalimumabUniversity of AlbertaAbbottNot recruiting18 YearsN/ABoth0Phase 4Canada
627NCT00851565June 200919 February 2015Use 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 TherapyCrohn's DiseaseProcedure: Measurement of serum infliximab and anti-infliximab antibodies;Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab statusCopenhagen University Hospital at HerlevAase and Ejnar Danielsens Foundation;Beckett Foundation;the Danish Biotechnology Program;Danish Colitis-Crohn Society;Danish Medical Association Research Fund;Frode V. Nyegaard and wife’s Foundation;Health Science Research Foundation of Region of Copenhagen;Herlev Hospital Research Council;Lundbeck Foundation;P. Carl Petersens Fund;Biomonitor A/S;Prometheus Inc.;The Danish Institute for Health Services ResearchNot recruiting18 YearsN/ABoth120Phase 4Denmark
628NCT01372969June 200923 April 2019Study 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.Not recruiting18 YearsN/AAll24Phase 1/Phase 2Spain
629NCT00790933May 22, 200926 February 2018An 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: VedolizumabTakedaNot recruiting18 YearsN/AAll2243Phase 3United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic
630EUCTR2008-008359-40-AT07/05/200919 March 2012A 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 - A2202Moderate 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
Pharmaceutical Form: Powder for solution for infusion
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
72Germany;Poland;Austria
No.TrialIDDate_
enrollement
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631JPRN-UMIN0000026042009/05/012 April 2019Combined therapy of infliximab with surgery in maintenance of remission in Crohn's diseaseCrohn'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 JapanNot Recruiting18years-oldNot applicableMale and Female100Phase 4Japan
632NCT00742781May 200919 October 2017Vitamin D Supplementation in Crohn's PatientsVitamin D and Crohn's Disease From the Bench to the ClinicInflammatory Bowel DiseaseDietary Supplement: Vitamin DPenn State UniversityNot recruiting18 Years70 YearsAll21Phase 1United States
633NCT00889161May 200919 February 2015Curcumin 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 HospitalNot recruiting8 Years18 YearsBoth11Phase 1United States
634NCT01510431May 200924 October 2016Safety 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 International SàrlNot recruiting18 Years70 YearsBoth11N/AUnited States
635EUCTR2008-001137-99-GB28/04/200920 March 2012CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's diseaseCHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's diseaseCrohn's Disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Ciprofloxacin
Product Code: PL 20532/0012
Pharmaceutical Form: Tablet
INN or Proposed INN: Ciprofloxacin hydrochloride
CAS Number: 86393-32-0
Current Sponsor code: 3591
Concentration unit: mg milligram(s)
Concentration type: not less then
Product Name: Budesonide
Product Code: PL 17901/0122
Pharmaceutical Form: Capsule
INN or Proposed INN: Budesonide
Current Sponsor code: 3591
Other descriptive name: Entocort CR
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 9-3
Trade Name: DOXYCYCLINE
Product Name: DOXYCYCLINE
Pharmaceutical Form: Tablet
INN or Proposed INN: DOXYCYCLINE HYCLATE
CAS Number: 564-25-0
Current Sponsor code: 3591
Other descriptive name: DOXYCYCLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-200
Trade Name: HYDROXYCHLOROQUINE
Product Name: HYDROXYCHLOROQUINE SULPHATE
Pharmaceutical Form: Coated tablet
INN or Proposed INN: HYDROXYCHLOROQUINE SULPHATE
CAS Number: 747-36-4
Current Sponsor code: PL17907/0017
Other descriptive name: PLAQUENIL
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 200-600
Royal Liverpool & Broadgreen University Hospitals TrustUniversity of LiverpoolAuthorisedFemale: yes
Male: yes
100United Kingdom
No.TrialIDDate_
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636EUCTR2008-002784-14-EE28/04/20095 February 2018An 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 DiseaseUlcerative 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 Level: LLT 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Millennium Pharmaceuticals, Inc.Not 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
637EUCTR2008-007519-34-SE17/04/200919 March 2012Feasibility 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 VERSIONThis 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: Remicade
Pharmaceutical Form: Powder and solvent for solution for infusion
University of Leuven Hospitals, Division of GastroenterologyAuthorisedFemale: yes
Male: yes
200Sweden
638EUCTR2008-006484-36-IT16/04/200923 May 2012MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE AND ANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION IN PEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASEMULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE AND ANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION IN PEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASEModerate-to-severe active Crohn`s disease.
MedDRA version: 9.1 Level: LLT Classification code 10011398 Term: Crohn's
Trade Name: REMICADE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMANot RecruitingFemale: yes
Male: yes
Italy
639NCT00899678April 200919 October 2017The 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 CelltechNot recruiting6 Years17 YearsAll99Phase 2United States;Australia;Canada;New Zealand
640EUCTR2009-009926-94-DK26/03/20098 August 2016Use 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 therapyPatients 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
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Humira
Pharmaceutical Form: Solution for injection
Department of medical gastroenterology, Herlev HospitalNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
No.TrialIDDate_
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641EUCTR2008-002783-33-ES02/03/200911 September 2012A Phase 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 Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002 en pacientes con enfermedad de Crohn moderada o grave.A Phase 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 Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002 en pacientes con enfermedad de Crohn moderada o grave.Moderate to Severe Crohn's Disease Enfermedad de Crohn moderada o grave
MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns ;Moderate to Severe Crohn's Disease Enfermedad de Crohn moderada o grave
MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns
Product Name: VEDOLIZUMAB
Product Code: MLN0002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Code: MLN0002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Millennium Pharmaceuticals, Inc.AuthorisedFemale: 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
642EUCTR2007-005455-42-NL26/02/200923 December 2013ENDO ACE TRIAL Endoscopic 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 TRIAL Endoscopic 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 TRIALCrohn'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
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: BUDESONIDE
CAS Number: 51333223
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3 -mg
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Kenacort
Product Name: Kenacort
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRIAMCINOLONE
CAS Number: 124947
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-mg/ml
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intraileal use (Noncurrent)
University Medical Center UtrechtNot RecruitingFemale: yes
Male: yes
42Netherlands
643EUCTR2008-000649-77-NL06/02/200919 March 2012A 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 Therapy - CERTIFIA 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 Therapy - CERTIFIModerately 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ustekinumab
Current Sponsor code: CNTO 1275
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Ustekinumab
Product Code: CNTO 1275
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ustekinumab
Current Sponsor code: CNTO 1275
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90 -
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Centocor BVNot RecruitingFemale: yes
Male: yes
500Phase 2bUnited Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
644EUCTR2008-007329-38-IT06/02/200919 March 2012Multicenter, 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 DiseasePatients 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: dexamethasone sodium phosphate
CAS Number: 2392-39-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Route of administration not applicable
ERYDEL S.P.A.Not RecruitingFemale: yes
Male: yes
184Spain;Italy
645NCT00245505February 200919 February 2015The 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 PharmaceuticalsNot recruiting18 Years70 YearsBoth3Phase 3Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
646EUCTR2008-002100-26-BE28/01/200927 January 2014PENTASA 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 - PEACEActive mild to moderate crohn's disease.
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Trade Name: PENTASA Sachet
Pharmaceutical Form: Prolonged-release granules
INN or Proposed INN: MESALAZINE
CAS Number: 89576
Current Sponsor code: FE999907
Other descriptive name: Mesalamine, 5-aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2000-
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Ferring Pharmaceuticals A/SNot RecruitingFemale: yes
Male: yes
510France;Belgium;Denmark;Germany;United Kingdom;Sweden
647EUCTR2008-005903-25-DE08/01/20094 March 2013Exploratory, 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
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SC12267
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 35-
Trade Name: Prednisolon Jenapharm
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Prednisolon Jenapharm
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Prednisolon Jenapharm
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
4SC AGNot RecruitingFemale: yes
Male: yes
35Bulgaria;Germany
648NCT00844285January 20094 November 2019SECURE, 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 PharmaNot recruiting18 YearsN/AAll3045Phase 1United States
649NCT01429922January 200919 February 2015Healthy 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 ServicesNot recruiting18 Years50 YearsBoth60Phase 1/Phase 2United States
650NCT00771667December 200819 October 2017A 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 - Plac