DDrare: Database of Drug Development for Rare Diseases

96. クローン病
［臨床試験数：2,209，薬物数：1,276（DrugBank：240），標的遺伝子数：166，標的パスウェイ数：210］

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

Drug = -aminosalicylic acid; 0,25 mg RPC1063; 0.25 mg RPC1063; 0114-0006B; 10 mg; 10% Metronidazole Ointment; 1000 IU D3; 13-valent pneumococcal conjugated vaccine (PCV13); 18F-FDG; 1mg RPC1063; 2'-Fucosyllactose; 23-valent polysaccharide pneumococcal vaccine; 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM); 25 mg Ontamalimab; 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III); 331731-18-1; 4-Aminosalicylic acid; 4-Aminosalicylic acid extended release granules; 40 mg; 40 mg MSB11022; 42942019; 5-ASA; 5-Aminosalicyl acid; 5-Aminosalicylic acid; 5-HTP; 5-aminolevulinic acid; 5-aminosalicylate (Pentasa, Ferring); 5-aminosalicylic acid; 5000 IU D3; 549-0261/F02-01; 6 Mercaptopurine; 6 mercaptopurine; 6-MP; 6-Mercaptopurine; 6-Mercaptopurine (Puri-Nethol); 6-Mercaptopurine (Puri-nethol); 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine; 683699; 75 mg Ontamalimab; 80 mg DR-6MP; 99mTc-S-HYNIC Certolizumab pegol; ?-3 polyunsaturated fatty acid; A fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine; A-1293543.74; AB1010; ABBV-066; ABR-215062 sodium salt; ABT 494 12mg; ABT 494 3mg; ABT Humira; ABT-494; ABT-874; ABX464; ADALIMUMAB; ADSVF; AIN457; ALBUMINE HUMAINE; ALLO-ASC; ALLO-ASC-CD; ALLOPURINOL; ALLOPURINOL SODIUM; ALX-0600; AMG 139; AMG 181; AMG 827; AMG 827 210 MG; AMG 827 350 MG; AMG 827 700 MG; AMGEVITA (Adalimumab biosimilar ); AMGEVITA®; AMINOSALICYLIC ACID; AN100226; APD334; APD371; AR401959 L-arginine; AS; ASA; ASC; ASCs; ASCs: Adipose derived Stem Cells; AST-120; ATG; AZA; AZATHIOPRINE; AZATHIOPRINE or METHOTREXATE; AZD9056; AZITHROMYCIN; Abatacept; Abrilumab; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion; Acetaminophen; Acetate; Adalimumab; Adalimumab (40 mg); Adalimumab (D2E7); Adalimumab 40 mg eow or ew; Adalimumab Injection; Adalimumab PRN; Adalimumab and Infliximab; Adult human mesenchymal stem cells; Agri-King Synbiotic (AKSB); Albendazole; Albendazole (Eskazole); Albumen; Aldesleukin; Alemtuzumab; Alequel; Alfacalcidol; Alicaforsen; Alicalm (polymeric liquid formula); Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs); Allogeneic Stem Cell Therapy; Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601; Allogenic eASCs 5 million cells/ml suspension for injection CX601; Allogenic eASCs 5 million cells/ml suspension for injection. CX601; Allogenic eASCs 5 million/ml suspension for injection.; Allopurinol; Allopurinol Sandoz 100 mg, tabletten; Alofisel; Amgevita; Amgevita 40 mg Injektionslösung im Fertigpen; Amgevita 40 mg Injektionslösung in einer Fertigspritze; Amgevita 40Mg Solution for Injection; Aminolevulinic acid; Aminosalicylic acid; Ammonium chloride; Amoxicillin; Andecaliximab; AndoSan; Anti TNF; Anti TNF Alfa.; Anti TNF humanized antibody Fab fragment-PEG conjugate; Anti TNF therapy including infliximab; Anti-CD3; Anti-CD3 Monoclonal antibody; Anti-IL-12; Anti-IL-23 monoclonal antibody; Anti-IL-6 mAb; Anti-Interferon-gamma monoclonal antibody; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; Anti-Interleukin-6 Monoclonal Antibody; Anti-MAdCAM antibody; Anti-TNF; Anti-TNF Drug; Anti-TNF Therapy; Anti-TNF discontinuation: Physiological saline solution; Anti-TNF: Infliximab (Infusion); Anti-TNF:Adalimumab (Subcutaneus); Anti-thymocyte globulin (rabbit); Anticorpo monoclonale anti IL-23; Anticorpo monoclonale anti-IL-23; Antithymocyte immunoglobulin; Antithymocyte immunoglobulin (rabbit); Apixaban; Apixaban 2.5 milligram; Application of Adalimumab; Arginine; Atorvastatin; Autologous ADIpose derived stromal vascular fraction; Autologous CD34-selected peripheral blood stem cells transplant; Autologous Stem Cell Transplantation; Autologous mesenchymal stromal cell; Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population; Azathioprin; Azathioprin-ratiopharm 25 mg; Azathioprin-ratiopharm 25mg Filmtabletten; Azathioprin-ratiopharm 50 mg Filmtabletten; Azathioprine; Azathioprine (AZA) caps; Azathioprine (AZA) or 6-mercaptopurine (6-MP); Azathioprine - ratiopharm 50 mg; Azathioprine / 6 Mercaptopurine; Azathioprine OR Mesalazine; Azathioprine in case of endoscopic recurrence; Azathioprine individualised dose; Azathioprine or 6-mercaptopurine; Azathioprine or adalimumab and infliximab; Azathioprine weight-based dose; Azathioprine+enteral nutrition; Azatioprina; Azithromycin; Azithromycin + Metronidazole; B. theta; BFAHF-2; BI 655066; BI 655066 10 mg/ml; BI 655066 90 mg/ml; BI 655130; BI 695501; BIBR 796 BS, 20 mg; BIBR 796 BS, 5 mg; BLI-1300 high dose; BLI-1300 low dose; BMS-188667; BMS-936557; BMS-936557 (Anti-IP-10 Antibody); BMS-945429; BMS-986165; BMS986165; BRAZIKUMAB; BT-11; BT-11 1,000 mg; BT-11 1000mg; BT-11 500 mg; BT-11 Active; BUDESONIDE; Bacteriophage preparation; Bacteriotherapy; Bean; Behavioral: AbbVie Care 2.0; Behavioral: Diet Counseling; Behavioral: Dyadic Psychological Support (DPS); Behavioral: Hypnosis; Behavioral: TIP / IMPACT Plus Care Coordination; Beta carotene; Beta carotene from Dunaliella algae; Betamethasone; Bezlotoxumab; Bifidobacterium infantis; Bifidobacterium infantis 35624; Biological samplings; Biosimilar; Biosimilar infliximab; Bleomycin; Blood and stools samples; Blood sampling; Bone Marrow Derived Mesenchymal Stem cells (MSCs); Boulardii; Brazikumab; Brazikumab IV Infusion; Brazikumab SC Injection; Brazikumab high dose; Brazikumab low dose; Budenofalk; Budenofalk 3mg gastro-resistant capsules; Budenofalk 9mg gastro-resistant granules; Budesonide; Budesonide ( Zentacort Capsules 3mg ); Bupivacaine; Bupivacaine/epinephrine/dexamethasone; Bupropion; By demand; C326, IL-6 Inhibitory Avimer protein; CC; CC-5013; CCX282-B; CD; CDP6038; CDP870; CERTOLIZUMAB PEGOL; CHENODEOXYCHOLIC ACID; CHLORURE DE SODIUM; CHOLECALCIFEROL; CHOLECALCIFEROL CONCENTRATE; CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM); CLARITHROMYCIN; CLOFAZIMINE; CNTO 1275; CNTO1275; CNTO1959; CP; CP-461; CP-690,550; CP-690,550-10; CPSI-2364; CROWN; CT-P13; CT-P13 SC (Infliximab); CTLA4Ig; CURCUMA LONGA RHIZOMA; Caffeine; Caffeine 100 mg; Calcitonin nasal spray (salmon); Calcitriol; Calcium; Calcium Carbonate; Calcium carbonate; Caltrate Pill; Cannabidiol; Cannabidiol , synthetic form; Cannabis; Cannabis, Medical; Carbon; Carbonate; Carnitine; Celebrex; Cellulose; Certican; Certolizumab; Certolizumab Pegol; Certolizumab Pegol (CDP870); Certolizumab Pegol /Cimzia; Certolizumab pegol; Certolizumab pegol (CDP870); Certolizumab pegol (CDP870, CZP); Certolizumab pegol (CZP); Certolizumab pegol (rINN); Certolizumab pegol 400 mg; ChAdOx2 HAV; Chenodeoxycholic acid; Chenodiol; Chenofalk; Chimeric IgG1 monoclonal antibody; Chloride; Chlorure de sodium; Cholecalciferol; Cholecalciferol 10,000 IU; Cholecalciferol 400 IU; Cholestagel; Chondroitin sulfate; Cimzia; Cimzia 200 mg solution for injection; Ciprofloxacin; Ciprofloxacin hydrochloride; Clarithromycin; Clofarabine; Clofazimine; Coffee; Colecalciferol; Colecalciferol D3 (Vigantol Oil); Colesevelam; Colony-purified Bacteroides thetaiotaomicron (B.theta); Contrast enhanced ultrasound; Cortecosteroid; Corticosteroid; CosmoFer; CosmoFer 50mg/ml solution for infusion or injection; Crohn's Disease; Crohns Disease Exclusion Diet + PEN; Curcuma; Curcuma Longa; Curcumin; Cx401; Cx601; Cyclophosphamide; Cyclophosphamide monohydrate; Cyltezo; Cytochrome P450 (CYP) Substrates; Cytoxan; D-CURA; D-Cura; D9421-C; D9421-C capsule 3 mg; D9421-C, 15mg; D9421-C, 9mg; DARVADSTROCEL; DB adalimumab 40 mg eow; DB adalimumab 40 mg ew; DHEA; DLX105; DOXYCYCLINE; DOXYCYCLINE HYCLATE; Darvadstrocel; Decortin 20 mg; Decortin 5 mg; Dehydroepiandrosterone; Dehydroepiandrosterone [DHEA]; Dekristol 20.000 ie; Delayed Release 6 mercaptopurine; Delayed Release 6MP or Calcitriol vs. Purinethol; Denosumab; Device: Capsule endoscopy; Device: Contrast Enhanced Ultrasound; Device: Endopath from Itamar medical - FDA approved device.; Device: Fluorescence endoscopy and spectroscopy; Device: Magnetic Resonance Enterography (MRE); Device: PMA-zeolite; Device: Ultrasound Elastography; Device: Ultrasound Imaging; Device: Ultrasound Vascularity; Device: cellulose; Dexametasona; Dexamethasone; Dexamethasone sodium phosphate; Dexamethasone sodium phosphate 250 mg/ 10 ml; Dextran; Dextromethorphan; Dextromethorphan 30 mg; Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT; Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels; Diet 1; Diet 2; Dietary therapy; Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon; Diflucan; Diphenhydramine; Doxycycline; E-Device; E6011; E6011 10 mg/kg; E6011 15 mg/kg; E6011 2 mg/kg; E6011 5 mg/kg; EB8018; EB8018 (First-in-class FimH blocker); EEN; EEN intervention group; EFALIZUMAB; EGG WHITE PROTEIN; EMEA/H/C/000240; EMEA/H/C/002778; ENDOXAN BAXTER; ENTYVIO; ERB-041; ERY-DEX; ETROLIZUMAB; EU/1/03/268/002; EU/1/99/116/003; Early immunosuppressants (azathioprine, methotrexate); Efalizumab; Egg; Egg Albumen Powder; Egg white; Eicosapentaenoic acid; Endoxan; Entecavir; Enteral nutrition; Enteral nutrition.; Entocort; Entocort CR; Entocort® Kapseln; Entyvio; Epanova; Epanova™ (Omega-3 Free Fatty Acids); Epaxal Berna (virosomal hepatitis A vaccine); Epinephrine; Ergocalciferol; Erythropoietin; Eskazole; Etiprednol dicloacetate; Etrasimod; Etrasimod L-arginine; Etrolizumab; Evaluation of biological predictive factors of clinical response to ustekinumab; Everolimus; Exclusive Enteral Nutrition; Exclusive Enteral Nutrition Therapy; Expanded allogenic adipose-derived adult stem cells; Expanded autologous adipose-derived adult stem cells (eASCs); Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs); Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs); Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue; Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs; Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs); FE 999301; FFP104; FILGOTINIB; FITC-Adalimumab; FLUCONAZOLE; FMT; FOS; Faecal Microbiota Transplantation; Fecal Microbial Transplantation; Fecal Microbial transplant; Fecal Microbiota Transplant; Fecal Microbiota Transplant (FMT); Fecal Microbiota Transplantation; Fecal Microbiota Transplantation (FMT); Fecal microbiota; Fecal microbiota transplantation; Ferric Carboxy Maltose; Ferric Maltol; Ferric carboxymaltose; Ferric maltol; Ferrous sulphate; Filgotinib; Filgrastim; Fish oil; Flagyl; Flixabi; Fluconazole; Fludarabine; Fludarabine Phosphate; Fludarabine phosphate; FolateScan (Technetium Tc 99mEC20); Fosfato sodico de dexametasona; Fosfomycin; Fully humanised, recombinant monoclonal antibody (IgG1); G-CSF; G321605; GED-0301; GLPG0634; GLPG1205; GOLIMUMAB; GS-5745; GS-6034; GSK1070806; GSK1605786; GSK1605786 500 mg; GSK1605786 ChemoCentryx: formulation A; GSK1605786 GSK direct-fill: formulation C; GSK1605786 GSK modified-process: formulation D; GSK1605786 GSK tablet: formulation E; GSK1605786 GSK: formulation B; GSK1605786 capsule; GSK1605786A; GSK2330811; GUSELKUMAB; Genetic: TPMT genotyping; Genetic: genetic analysis; Glatiramer; Glatiramer acetate; Glucose; Glutamine; Gold; Golimumab; Green Tea; Group 2 ustekinumab 130 mg; Group 3: ustekinumab approximately 6 mg/kg; Growth Hormone; Growth hormone; Guselkumab; Guselkumab Dose 1; Guselkumab Dose 2; Guselkumab Dose 3; Guselkumab Dose 4; Guselkumab Dose 5; HMPL-004; HMPL004-6599; HUMAN ALBUMIN AS MACROAGGREGATES; HUMAN PLASMA FOR FRACTIONATION; HUMIRA; HUMIRA (adalimumab); HUMIRA 40 mg solución inyectable en jeringa precargada; HUMIRA 40Mg Solution for Injection; HUMIRA ®; HUMIRA*SC 2SIR+F 40MG 0,8ML+2T; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE SULPHATE; Hematopoietic stem cell transplantation; Hepatitis A Vaccine; Herpes Zoster Vaccine; Hextend; High Oligosaccharide Group; High dose TSO; High-dose Cyclophosphamide; HuM291; Hulio; Human Anti-IL-12 Antibody; Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Human Placenta-Derived Cells PDA001 Intravenous Infusion; Human albumin; Human anti-IP10 monoclonal antibody; Human insulin; Humira; Humira (adalimumab original); Humira (adalimumab); Humira 20 mg solution for injection in pre-filled syringe; Humira 40 mg injekcní roztok v predplnené injekcní stríkacce; Humira 40 mg solution for injection in pre-filled pen; Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg/0.8 ml solution for injection; Humira 40mg/0.4ml pre-filled syringe; Humira 40mg/0.8ml solution for injection for paediatric use; Humira pre-filled PEN; Humira®; Hydroxide; Hydroxychloroquine; IGG2 ANTIBODIES; IL-2; IM90838; IMP will be labeled as ''PF-04236921 106mg/vial, Clonal SC lyophilized form''.; IMP will be labeled as PF-04236921 106mg/vial, Clonal SC lyophilized form; IMU-838; IMUREL; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN-2; ITF 2357; ITF2357; Immune Ablation and Hematopoietic Stem Cell Support; Immunonutrition; Immunosuppressor/TNFalpha; Impact; Imraldi; Imuran; Imurel; Imurel 25 mg; InVita D3; Increlex; Increlex 10mg/ml solution for injection; Indocyanine green; Inflectra; Inflectra 100 mg powder for concentrate for solution for infusion; Infliximab; Infliximab (IFX alone); Infliximab (Remicade); Infliximab (Remicade): 100 mg of lyophilized infliximab; Infliximab 10 mg/kg; Infliximab 20 mg/kg; Infliximab 5 mg/kg; Infliximab 5 mg/kg body weight infused over 2 hours; Infliximab 5 mg/kg every 6 weeks; Infliximab 7 mg/kg every 8 weeks; Infliximab [infliximab biosimilar 3]; Infliximab and adalimumab; Infliximab and azathioprine combination at week 0; Infliximab and azathioprine combination at week 14; Infliximab infusion; Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab; Infliximab with azathioprine (IIFX + AZA); Infliximab+azathioprine; Infliximab, adalimumab, certolizumab pegol; Infliximab, azathioprine; Infliximab-Biosimilar; Infliximab-Innovator; Injection of iron; Innovator infliximab; Inositol; Interferon alfa; Interferon beta; Interferon beta-1a; Interleukin 2; Interleukin-11; Interleukin-2 (aldesleukin).; Intralipid; Intralipid 10%; Intralipid 20%; Inulin; Iron; Iron Sucrose; Iron sucrose; Iron sulphate; Iron sulphate 200mg coated tablets; Iron supplement 300-600 mg/day; Iron(III)- hydroxide dextran complex; J695; J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0; JNJ-40346527; JNJ-40346527-AAC; JNJ-64304500; JNJ-64304500-AAA; JNJ-67864238; Kanamycin; Kenacort; Kremezin; Kremezin®, Spherical Adsorptive Carbon; L 44; L-Carnitine; L-carnitine; L01BA; LDP-02; LY3074828; Lactated Ringers; Lactobacillus salivarius UCC118; Lactulose; Lactulose/Rhamnose solution; Lap TAP Bupivacaine/Epinephrine; Laquinimod; Laquinimod Capsules 0.5 mg; Laquinimod Cápsulas 0.5 mg; Leucine; Lipitor; Liposomal bupivacaine; Losartan; Low dose TSO; Low dose naltrexone; Low-dose IL-2 administration; Lumbar puncture; Lumentin 44; Lymphocyte immune globulin; MB-102; MDGN-002; MDX-1100; MEDI2070; MERCAPTOPURINE; MESALAZINE; METHOTREXATE; METHOTREXATE DISODIUM; METRONIDAZOLE; MICROBIOTA; MIRIKIZUMAB; MLN0002; MLN0002 (Vedolizumab); MLN0002 SC; MLN002; MODULEN IBD; MODULEN IBD (R) (specific Enteral Nutrition); MONOCLONAL ANTIBODY ANTI-IGG1; MSC; MSC injection 01; MSC injection 02; MSC treatment 01; MSC treatment 02; MSC-AFP; MT-1303; MTX; MVA; MVA HAV; Maltodextrin; Maltose; Mango; Mango polyphenolics; Mannitol; Mare´s milk; Masitinib; Masitinib mesylate; Mecasermin; Mecasermin [rDNA Origin] 10mg/ml solution; Medium chain triglycerides; Medium dose TSO; Melphalan; Mensa; Mercaptopurine; Mesalamine; Mesalamine, 5-aminosalicylic acid; Mesalazine; Mesalazine (Mesalamine); Mesalazine EC 500 mg; Mesalazine Sustained-Release Tablets; Mesalazine tablets; Mesalazine, Tripterygium glycosides; Mesenchymal Stem Cells; Mesenchymal Stem Cells (MSC); Mesenchymal Stromal Cells; Mesenchymal cell and fibroblast injection; Mesenchymal cell transplantation; Mesenchymal stem cells; Mesenchymal stem cells (MSCs); Mesenchymal stromal cells (MSC) for infusion; Mesna; Methacholine; Methotrexat; Methotrexate; Methotrexate injection; Methoxsalen; Methoxsalen +ECP; Methyl prednisolone; Methylprednisolone; Methylprednisolone or budesonide; Metoject; Metotrexat; Metronidazol; Metronidazole; Midazolam; Midazolam 2 mg; Midazolam 3 mg; Mirikizumab; Mobilization of stem cells to prepare for Leukapheresis; Moderate Oligosaccharide Group; Modulen; Mongersen; Monoclonal antibodies; Monoclonal antibody cA2; Mosapride; Movprep; Mycodigest supplement; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolic Acid; Mycophenolic acid; N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium; N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium; N.a.; NI-0401 (anti-CD3 mAB); NNC 0142-0000-0002; NNC0114-0006; NNC0142-0000-0002; NNC142-0002; NORMIX*AD 12CPR RIV 200MG; NSP001; Naltrexone; Naltrexone hydrochloride; Naltrexone-HCl; Nap; Natalizumab; Neomycin; Nessuno; Nitazoxanide; Nivolumab; None; None at this time; Normal Saline; Normix; Null; Nutraceutical Combination; Nutrition treat; Nutritional dietary intervention; NutropinAq 10mg/2ml solution for injection; NutropinAq®; OL adalimumab 40 mg; OPC-6535; OPC-6535(Tetomilast); OPS-2071; OPS-2071 150 mg; OPS-2071 300 mg; OPS-2071 600 mg; OZANIMOD; Oligofructose enriched inulin; Olokizumab; Olokizumab (OKZ); Omega-3; Omegaven; Omegaven 10%; Omeprazole; Omeprazole 20 mg; Omeprazole 40 mg; Only 1 arm: treatment with MSC-AFP; Ontamalimab; Optison; Orencia; Originator (legacy) drug; Other Biologic Therapies; Other Biological Agent; Other: 100% pomegranate juice; Other: 5-ASA Withdrawal; Other: Acute response to high-impact exercise; Other: Blood Test; Other: CD LFD; Other: CD-TREAT diet; Other: Coffee; Other: Control Diet; Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet); Other: Crohns Disease Exclusion Diet; Other: Diet-CD; Other: Exclusion Diet; Other: Exclusive Enteral Nutrition (EEN); Other: Exclusive enteral nutrition; Other: Fractional Exhaled NO (FENO); Other: Green tea (Camellia sinensis); Other: High energy / protein diet.; Other: High-impact exercise intervention; Other: Hyperbaric oxygen; Other: IV saline infusion; Other: Intensify treatment with the existing drug; Other: Laboratory Biomarker Analysis; Other: Lengthening adalimumab dosing interval; Other: Leukapheresis- Collection of stem cells; Other: Low n-6 PUFA Diet; Other: Measurement of drug (Adalimumab/Infliximab); Other: Methacholine Challenge Test; Other: NS; Other: Other Biologic Agents; Other: PCDAI; Other: Quality-of-Life Assessment; Other: Questionnaires; Other: Standard nutrition; Other: Standard of Care; Other: Stem Cell Transplant; Other: Threonine; Other: UC-MSCs by peripheral intravenous infusion; Other: enteral nutrition; Other: high performance liquid chromatography; Other: infliximab (IFX) infusion; Other: laboratory biomarker analysis; Other: normal diet; Other: surgery; Other: triangular test; Ova-Treg; Ovasave; Oxadrop; Oxygen; Ozanimod; Ozanimod hydrochloride; P28GST; PDA001; PEG; PENTASA Sachet; PF 06687234; PF-00547659; PF-00547659 SC injection; PF-04236921; PF-04236921 SC injection; PF-06651600; PF-06651600 50 mg; PF-06651600-15; PF-06700841; PF-06700841 25 mg; PF-06700841 5 mg; PF-06700841-15; PL 17901/0122; PL 20532/0012; PLAQUENIL; PREDNISONE; PROCHYMAL (remestemcel-L); PROCHYMAL adult human mesenchymal stem cells; PRV-6527; PRV-6527 (JNJ-40346527); PRV-6527(JNJ-40346527); PTG-200; PURINETHOL; Pectin; Pegylated interferon alfa; Pending; Pentasa; Pentasa Sachet 1 g; Pentasa Sachet 1 g prolonged release granules; Pentoxifylline; Peptidic+Probiotic; Peripheral Blood Stem Cell Infusion; Pharmacokinetics of certolizumab pegol; Phosphate; Phylloquinone; Phylloquinone (vitamin K1); Physician standard-of-care; Pioglitazone; Pioglitazone 15 mg; Placebo; Plantain NSP; Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI); Pnemovax; Pneumovax; Polaprezinc; Polyethylene Glycol 3350; Polyethylene glycol; Pomegranate; Postoperative 3-month exclusive enteral nutrition; Pravastatin; Prebiotics; Prednisolon; Prednisolon Jenapharm; Prednisolone; Prednisone; Preparative regimen 4-6 weeks after Leukapheresis; Prevenar 13; Previously referred to as MEDI2070 and AMG 139; Previously referred to as MEDI2070 and AMG 139, AGN-151-598; Probiotic; Probiotic - VSL#3; Probiotic Mixture; Probiotics; Procedure: Allogeneic Bone Marrow Transplantation; Procedure: Apheresis catheter placement; Procedure: Autologous stem cell transplant; Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Blue light photopheresis; Procedure: Breast milk sampling; Procedure: Computed Tomography; Procedure: Continuous Mononuclear Cell Collection (CMNC); Procedure: DEXA scan; Procedure: EUA with seton placement if necessary; Procedure: EUS; Procedure: Endoscopic balloon dilatation; Procedure: Extracorporeal Photopheresis; Procedure: FMT; Procedure: Ileocolonoscopy; Procedure: Instillation of fibrin glue; Procedure: Intestinal surgery for Crohn's Disease; Procedure: Leukapheresis; Procedure: Measurement of serum infliximab and anti-infliximab antibodies; Procedure: Positron Emission Tomography; Procedure: Routine drainage surgery; Procedure: Small bowel follow trough; Procedure: Transfusion; Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status; Procedure: WMT; Procedure: Whole body Protein turnover; Procedure: ileocecal resection; Procedure: lumbar puncture; Prochymal™ adult human mesenchymal stem cells; Promethazine; Prucalopride; Puri-Nethol; Puri-Nethol 50 mg; Purinethol; QAX567; QAX576; QBECO; QBECO-SSI; RAD001; RCTB-401; REMICADE; REMSIMA; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; REMSINA; RHB-104; RIFABUTIN; RIFAXIMIN; RIFAXIMINA; RISANKIZUMAB; RPC0163; RPC1063; RPC1063 (equivalent to ozanimod; RPC1063 (equivalent to ozanimod HCl); RR110 (Tamibarotene); RVG 05565; RVG 07151; Rabbit; Rabbit anti-human thymocyte immunoglobulin; Rabbit antithymocyte globulin; Racol; Radiation: Fluorine F 18 Clofarabine; Radiation: Total-Body Irradiation; Ranolazine; Rapamycin; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; RbATG; Received hormone maintenance therapy; Recombinant Human Interleukin-11 (rhIL-11); Recombinant growth hormone; Recombinant human Insulin-like Growth Factor; Remestemcel-L; Remicade; Remicade (infliximab); Remicade 100 mg; Remicade 100 mg powder for concentrate for solution for infusion.; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima; Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima and Inflectra; RhGH; RhIGF (Increlex); Rhamnose; RhumAb to Il-17A (IgG1-k-class); RhumAb to Il-17A (IgG1-k-class) rhumAb to Il-17A (IgG1-k-class); Ribavirin; Riboflavin; Riboflavin Sodium Phosphate Injection; Riboflavin supplementation; Rifabutin; Rifabutin, Clarithromycin, and Clofazimine; Rifaximin; Rifaximin Delayed Release (DR); Rifaximin EIR; Rifaximin delayed release 400 mg film coated tablet; Rifaximin delayed release tablets; Rifaximin+omeprazole+miralax; Rifaximin-EIR; Rifaximina; Risankizumab; Risankizumab 10 mg/ml; Risankizumab 180 mg SC; Risankizumab 600 mg IV; Risankizumab 90 mg/ml; Risankizumab IV; Risankizumab SC; Risedronate; Rituximab; Rizankisumab; Rizankizumab; Ro 549-0261/F04-02; Ro 549-0261/F08-02; Rosuvastatin; Rosuvastatin 10 mg; Routine Treatment of CD; S38; SB5; SC12267; SC12267 (4SC-101); SERUM ALBUMINE 5%; SHP647; SHR0302; SMOFLipid; SODIUM CHLORIDE; ST10; ST10-021; STA-5326; STA-5326 mesylate; STA-6838, STA-5326 m, S38; STELARA; STELARA 130 mg concentrate for solution for infusion; STELARA 90 mg solution for injection in pre-filled syringe; STELARA®; SUB20016; SULFUR HEXAFLUORIDE; Salmon; Salofalk; Salofalk 500 mg; Sandostatine; Sargramostim; Sargramostim (Leukine); Search for exocrine pancreatic insufficiency at week 0 and 12; Selective Immunosuppressive agents; Semapimod; Serum bovine immunoglobulin; Serum physiologique 0.9 %; Shingrix; Sibofimloc; Simethicone; Sivelestat; Smoflipid; Smoking cigarettes; Smoking of cannabis; Sodium chloride; Solid food-based intervention; Somatropin; Somatropin [rDNA origin] for injection; Somatropin(rhGH); SonoVue; Sonovue; Soy protein; Soya Bean oil; Spesolilmab; Spesolimab; Stable isotope infusions; Standard 2 hours-infusion; Standard step-up care; Start adalimumab in monotherapy; Stelara; Stelara 130 mg concentrate for solution for infusion; Stelara 90 mg solution for injection in pre-filled syringe; Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra; Stem cells; Step-up; Steroids; Stromal vascular fraction (SVF); Sucrose; Sugar Extract; Sulfate; Sulfur Hexafluoride; Sulfur hexafluoride; Sulphur hexafluoride; Suspension containing 250 embryonated, viable TSO/15ml; Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml; Suspension containing 2500 embryonated, viable TSO/15ml; Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml; Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml; Suspension of 7500 embryonated, viable TSO/15ml; Suspension of adipose derived autologous adult stem cells; Synbiotic (Synergy I / B.longum); T2; TA-650; TAK-018; TBC; TD-1473; THALIDOMIDE CELGENE - 50 MG CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PE/ACLAR/ALU) 28 CAPSULE; THC; THC 5mg/ml and CBS 50mg/ml; THRX-139060; THYMOGLOBULINE; TNF Kinoid; TNF-K; TNF-Kinoid; TNF-alpha antagonists; TNFa Kinoid; TNFa-Kinoid; TR004 (Treg immunotherapy); TRIAMCINOLONE; TRK-170; TSO 250; TSO 2500; TSO 7500; TU-100; TV-5600; Tacrolimus; Tamibarotene; Tasty&Healthy intervention group; Teduglutide; Teduglutide (ALX-0600); Teduglutide 0.05; Teduglutide 0.05 dose; Teduglutide 0.1 mg dose; Teduglutide 0.2 mg; Tetomilast; Thalidomide; Thalidomide Pharmion; The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.; The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA; The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA.; Thetanix; Thiopurine; Thiotepa; Threonine; Thymoglobulin; Thymoglobuline; Ticilimumab; Time and attention; Time and attention + active fructooligosaccharide supplementation; To be determined; To be requested; Tofacitinib; Tofacitinib (CP-690,550); Tolerogenic Dendritic Cells; Top-down; Treatment with Adalimumab; Triamcinolone; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (TSO); Trichuris trichiura eggs; Tripterygium; Tripterygium glycosides; Tris; UC-MSCs; URSODEOXYCHOLIC ACID; US TAP Bupivacaine/Epinephrine; USTEKINUMAB; UTTR1147A; UTTR1147A, IL22-Fc, IL-22Fc; UTTR1147A/RO7021610 (Active); UVADEX; UVADEX and UVAR XTS Photopheresis System; Ultrasound Microbubble Contrast Agent; Undetermined; Upadacitinib; UrsoFalk; UrsoFalk® 250 mg tabletten.; Ursodeoxycholic acid; Ustekinumab; Ustekinumab (6 mg/kg); Ustekinumab (90 mg); Ustekinumab 130 mg IV; Ustekinumab 1mg/kg (IP); Ustekinumab 3 mg/kg (IP); Ustekinumab 4.5 mg/kg; Ustekinumab 6 mg/kg (IP); Ustekinumab 90 mg; Ustekinumab 90 mg (SC) Group 1; Ustekinumab 90 mg (SC) Group 2; Ustekinumab 90 mg SC q12w; Ustekinumab 90 mg SC q8w; Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP); Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP); Ustekinumab IV Infusion; Ustekinumab SC Injection; Ustekinumab approximately 6 mg/kg (IV); Usual current care; Uvadex; V565; VEDOLIZUMAB; VIALEBEX; VSL#3; VSL#3 (Original De Simone formulation); VSL#3®; Vancomycin; Vedolizumab; Vedolizumab (Genetical Recombination); Vedolizumab 300 MG Injection [Entyvio]; Vedolizumab IV; Vedolizumab IV (Entyvio™); Vedolizumab IV 300 mg; Vedolizumab SC; Vedolizumab SC 108 mg; Vedolizumab intravenous injection; Vedolizumab subcutaneous injection; Vedolizumab-800CW; Vehice Control; Verapamil; Viagra; Vialebex 200mg; Vidofludimus; Vidofludimus calcium; Vigantol; Vigantol Oel; Vigantol Oel TM; Visilizumab; Vitamin D; Vitamin D drops; Vitamin D3; Vitamin D3 3000 UI daily; Vitamin D3 4000 UI daily; Vitamin D3 800 UI/day then 800 UI/day; Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day; Vitamin E; Vitamin E 800IU; Vitamin K; Vitamin K 10 mg; Vitamin K1; Vorinostat; WFI; WMT; Warfarin; Warfarin 10 mg; Water; Wellbutrin (bupropion); Whey protein; Xanthohumol; Z-206; ZP1848; Zessly; Zoledronic acid; [124I]IB PF 06687234; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F]FSPG; [Cx601]; [OPS-2071]; [RPC0163]; [RPC1063]; ÁCIDO GADOBÉNICO

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04151225 (ClinicalTrials.gov)	April 5, 2021	4/11/2019	Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease	A 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 Disease	Crohns Disease	Drug: GSK2330811;Drug: Placebo	GlaxoSmithKline	NULL	Withdrawn	18 Years	N/A	All	0	Phase 2	NULL
2	NCT03870334 (ClinicalTrials.gov)	March 2021	8/3/2019	Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease	Crohn's Disease	Drug: BT-11 1,000 mg;Drug: Placebo	Landos Biopharma Inc.	NULL	Not yet recruiting	18 Years	75 Years	All	130	Phase 2	NULL
3	NCT04118088 (ClinicalTrials.gov)	January 15, 2021	4/10/2019	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula	Crohn's Disease;Complex Perianal Fistula	Biological: Darvadstrocel	Millennium Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	N/A	All	50	Phase 4	Austria;Czechia;France;Germany;Spain
4	ChiCTR2000036845	2021-01-01	2020-08-25	A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease	A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease	Crohn's disease	Proctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ;	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	NULL	Pending	18	70	Both	Proctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60;	Phase 4	China
5	NCT04643483 (ClinicalTrials.gov)	January 2021	19/11/2020	A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease	A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease	Crohn's Disease	Drug: Certolizumab pegol;Drug: Adalimumab;Drug: Placebo	UCB Biopharma SRL	NULL	Not yet recruiting	6 Years	17 Years	All	150	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT03992469 (ClinicalTrials.gov)	January 2021	18/6/2019	Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's Disease	Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease	Crohn's Disease	Drug: BFAHF-2;Drug: Placebo	Icahn School of Medicine at Mount Sinai	NULL	Not yet recruiting	18 Years	30 Years	All	28	Phase 1	United States
7	NCT04629196 (ClinicalTrials.gov)	January 2021	10/11/2020	Induction Optimization With Stelara for Crohn's Disease	Induction Optimization With Stelara for Crohn's Disease	Crohn Disease	Drug: Ustekinumab	NYU Langone Health	NULL	Not yet recruiting	18 Years	70 Years	All	113	Phase 4	United States
8	NCT04655807 (ClinicalTrials.gov)	December 16, 2020	30/11/2020	A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease	A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's Disease	Crohn Disease	Drug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: Ustekinumab	Janssen Research & Development, LLC	NULL	Not yet recruiting	18 Years	65 Years	All	70	Phase 2	United States;France;Germany;Italy;Spain;Sweden
9	NCT03414788 (ClinicalTrials.gov)	December 7, 2020	8/1/2018	Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease	PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS	Inflammatory Bowel Disease	Biological: PF 06687234;Biological: [124I]IB PF 06687234	Pfizer	NULL	Withdrawn	18 Years	75 Years	All	0	Phase 1	United States
10	EUCTR2020-002674-26-GB (EUCTR)	02/12/2020	26/11/2020	A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.	A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy.	Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	508	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT03747718 (ClinicalTrials.gov)	December 1, 2020	8/3/2018	Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children	A Study for Evaluation of Clinical Response to Single vs. Maintenance Fecal Microbiota Transplantation in Pediatric Patients With Refractory Crohn's Disease	Crohn Disease	Biological: Fecal Microbiota Transplantation;Other: Placebo	Stanford University	NULL	Not yet recruiting	2 Years	25 Years	All	30	Phase 1	United States
12	NCT04660136 (ClinicalTrials.gov)	December 1, 2020	2/12/2020	Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients	Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients	Crohn's Disease in Pediatric Patient	Biological: contrast enhanced ultrasound	Yonsei University	NULL	Recruiting	2 Years	18 Years	All	20	Phase 4	Korea, Republic of
13	NCT04263831 (ClinicalTrials.gov)	December 1, 2020	7/2/2020	LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE	LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE	Crohn Disease	Drug: Interleukin-2 (aldesleukin).	Boston Children's Hospital	NULL	Not yet recruiting	18 Years	80 Years	All	30	Phase 1;Phase 2	United States
14	NCT04530877 (ClinicalTrials.gov)	December 1, 2020	24/8/2020	Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients	Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease	Crohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal Healing	Biological: Infliximab;Dietary Supplement: Exclusive Enteral Nutrition	Children's Hospital of Fudan University	NULL	Not yet recruiting	1 Year	18 Years	All	80	Phase 4	NULL
15	NCT04073472 (ClinicalTrials.gov)	December 1, 2020	23/8/2019	Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's	A 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 Pouch	Crohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, Ileoanal	Drug: mesenchymal stem cells (MSCs)	The Cleveland Clinic	NULL	Not yet recruiting	18 Years	75 Years	All	15	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT04456517 (ClinicalTrials.gov)	December 2020	29/6/2020	Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy	REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea	Crohn's Disease;Inflammatory Bowel Disease	Drug: Ranolazine;Drug: Placebo	Vanderbilt University Medical Center	NULL	Not yet recruiting	18 Years	N/A	All	16	Phase 2	United States
17	EUCTR2020-002674-26-AT (EUCTR)	23/11/2020	18/11/2020	A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.	A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy.	Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	508	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
18	NCT04519671 (ClinicalTrials.gov)	November 19, 2020	17/8/2020	Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease	A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease	Perianal Crohn Disease;Perianal Fistula;Crohn Disease	Drug: Mesenchymal Stem Cells;Other: Placebo	The Cleveland Clinic	NULL	Recruiting	18 Years	75 Years	All	20	Phase 1;Phase 2	United States
19	EUCTR2017-003090-34-DK (EUCTR)	12/11/2020	15/06/2020	A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD	Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Phase 2	Hungary;Belgium;Austria;Denmark;Netherlands;Germany
20	NCT04112212 (ClinicalTrials.gov)	November 4, 2020	25/9/2019	NIR 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, Ulcerative	Drug: Vedolizumab -800CW;Device: Fluorescence endoscopy and spectroscopy	University Medical Center Groningen	NULL	Recruiting	18 Years	N/A	All	35	Phase 1	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2020-002674-26-NL (EUCTR)	29/10/2020	15/09/2020	A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.	A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy.	Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	508	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
22	NCT04519684 (ClinicalTrials.gov)	October 28, 2020	17/8/2020	Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's Disease	A Phase IB/IIA Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch	Ileal Pouch;Crohn Disease	Drug: Mesenchymal stem cells;Other: Placebo	The Cleveland Clinic	NULL	Recruiting	18 Years	75 Years	All	20	Phase 1;Phase 2	United States
23	NCT04519697 (ClinicalTrials.gov)	October 28, 2020	17/8/2020	Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease	A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.	Rectovaginal Fistula;Crohn Disease;Crohn Disease of Vulva;Rectolabial; Fistula	Drug: Mesenchymal Stem Cells;Other: Placebo	The Cleveland Clinic	NULL	Recruiting	18 Years	75 Years	Female	20	Phase 1;Phase 2	United States
24	ChiCTR2000035737	2020-10-01	2020-08-16	Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial	Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial	Crohn's disease	Experimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience;	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	NULL	Pending	18	70	Both	Experimental group:45;Control group:45;		China
25	NCT04535882 (ClinicalTrials.gov)	October 1, 2020	28/8/2020	Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD	Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease Colitis	LRG Levels	Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels	Showa Inan General Hospital	NULL	Recruiting	N/A	N/A	All	100		Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT04308850 (ClinicalTrials.gov)	October 2020	24/2/2020	Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency	Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency,a Prospective Cohort Study	Crohn's Disease;Vitamin D Deficiency;Vitamin D Supplement	Drug: Vitamin D drops	Second Affiliated Hospital of Wenzhou Medical University	NULL	Not yet recruiting	N/A	N/A	All	60	Early Phase 1	China
27	NCT04276636 (ClinicalTrials.gov)	October 2020	17/2/2020	Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency	Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort Study	Crohn's Disease;Vitamin D Deficiency;Vitamin D Supplement	Drug: Caltrate Pill	Second Affiliated Hospital of Wenzhou Medical University	NULL	Not yet recruiting	N/A	N/A	All	60	Early Phase 1	China
28	NCT04276649 (ClinicalTrials.gov)	October 2020	17/2/2020	Exploring the Effects of Caltrate Supplement on the Chronic Course of Ulcerative Colitis Patients With Vitamin D Deficiency	Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort Study	Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement	Drug: Caltrate Pill	Second Affiliated Hospital of Wenzhou Medical University	NULL	Not yet recruiting	N/A	N/A	All	60	Early Phase 1	China
29	EUCTR2020-001811-26-NL (EUCTR)	30/09/2020	08/07/2020	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study	Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Netherlands
30	NCT04524611 (ClinicalTrials.gov)	September 30, 2020	20/8/2020	Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)	A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy	Crohn's Disease (CD)	Drug: Risankizumab;Drug: Ustekinumab	AbbVie	NULL	Recruiting	18 Years	80 Years	All	517	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	NCT04223518 (ClinicalTrials.gov)	September 20, 2020	6/1/2020	Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)	Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease	Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo	Monisha Hitesh Shah	NULL	Recruiting	6 Years	30 Years	All	43	Early Phase 1	United States
32	EUCTR2018-004614-18-DK (EUCTR)	08/09/2020	05/08/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
33	ChiCTR2000037094	2020-09-01	2020-08-26	Discovery and detection of a novel antigen for Crohn’s disease (CD)	Discovery and detection of a novel antigen for Crohn’s disease (CD)	Inflammatory Bowel Disease	Gold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA;	The First Affiliated Hospital of Anhui Medical University	NULL	Completed	18	80	Both	Target condition:100;Difficult condition:100		China
34	NCT04331639 (ClinicalTrials.gov)	September 2020	23/3/2020	High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy	Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab	Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency	Dietary Supplement: vitamin D3	Boston Children's Hospital	NULL	Not yet recruiting	5 Years	25 Years	All	50	Phase 2	NULL
35	NCT04398836 (ClinicalTrials.gov)	September 2020	18/7/2019	Preoperative Nutrition for Crohn's Disease Patients	Preoperative Nutrition for Crohn's Disease Patients	Malnutrition;Crohn Disease	Dietary Supplement: Exclusive Enteral Nutrition;Other: High energy / protein diet.;Other: Standard nutrition	Tel-Aviv Sourasky Medical Center	NULL	Not yet recruiting	18 Years	70 Years	All	144	Phase 3	Israel
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	NCT04502303 (ClinicalTrials.gov)	September 2020	4/8/2020	18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease	A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT	Crohn Disease	Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT	Peking Union Medical College Hospital	NULL	Not yet recruiting	18 Years	N/A	All	30	Phase 2	NULL
37	EUCTR2018-004614-18-HR (EUCTR)	24/08/2020	23/11/2020	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
38	EUCTR2017-002491-10-AT (EUCTR)	19/08/2020	11/05/2020	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czech Republic;Spain;Austria;Germany;United Kingdom
39	EUCTR2019-002895-14-GB (EUCTR)	05/08/2020	02/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Slovenia;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China
40	EUCTR2019-002895-14-NL (EUCTR)	05/08/2020	23/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	NCT03943446 (ClinicalTrials.gov)	August 4, 2020	7/5/2019	TAK-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 Recurrence	Crohn Disease	Drug: TAK-018;Drug: TAK-018 Placebo	Millennium Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	N/A	All	96	Phase 2	United States;Austria;France;Germany;United Kingdom;Netherlands
42	NCT04362735 (ClinicalTrials.gov)	August 1, 2020	19/4/2020	Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy	Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world Study	Crohn Disease	Drug: Vedolizumab	Pontifícia Universidade Católica do Paraná	Takeda	Not yet recruiting	18 Years	N/A	All	100		NULL
43	EUCTR2019-002895-14-PT (EUCTR)	27/07/2020	06/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
44	EUCTR2017-002491-10-FR (EUCTR)	17/07/2020	09/03/2020	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czech Republic;Spain;Austria;Germany;United Kingdom
45	NCT04312659 (ClinicalTrials.gov)	July 15, 2020	3/3/2020	A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease	A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease	Crohn Disease	Drug: Infliximab	Johnson & Johnson (China) Investment Ltd.	NULL	Recruiting	6 Years	17 Years	All	40		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2019-001673-93-HU (EUCTR)	07/07/2020	09/06/2020	A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.	An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials	Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of
47	NCT03935451 (ClinicalTrials.gov)	July 1, 2020	23/4/2019	Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease	A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study	IBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal Disorders	Drug: Apixaban 2.5 milligram;Drug: Placebo Oral Tablet	McMaster University	NULL	Not yet recruiting	18 Years	N/A	All	60	Early Phase 1	NULL
48	EUCTR2019-003335-37-DE (EUCTR)	29/06/2020	27/11/2019	A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET	Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-67864238 Product Code: JNJ-67864238 INN or Proposed INN: Not available Other descriptive name: PTG-200	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	United States;Argentina;Poland;Russian Federation;Germany;Italy
49	EUCTR2017-002491-10-DE (EUCTR)	22/06/2020	09/03/2020	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom
50	EUCTR2017-001240-35-FR (EUCTR)	22/06/2020	09/03/2020	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	NCT04232553 (ClinicalTrials.gov)	June 22, 2020	15/1/2020	A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease	A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease	Crohn's Disease	Drug: Mirikizumab	Eli Lilly and Company	NULL	Recruiting	18 Years	N/A	All	778	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Romania;Russian Federation;Spain;Turkey;Ukraine
52	NCT04163016 (ClinicalTrials.gov)	June 19, 2020	24/10/2019	A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)	A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)	Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis	Drug: Pharmacokinetics of certolizumab pegol	UCB Biopharma S.P.R.L.	NULL	Recruiting	18 Years	N/A	Female	20	Phase 1	United States;Canada;Switzerland
53	EUCTR2018-004346-42-AT (EUCTR)	18/06/2020	21/01/2020	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
54	NCT04397263 (ClinicalTrials.gov)	June 10, 2020	18/5/2020	A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease	A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease	Crohns Disease	Drug: Guselkumab	Janssen Pharmaceutical K.K.	NULL	Recruiting	18 Years	N/A	All	25	Phase 3	Japan
55	JPRN-JapicCTI-205298	10/6/2020	26/05/2020	A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease	Crohn's Disease	Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Janssen Pharmaceutical K.K.	NULL	pending	18		BOTH	25	Phase 3	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2019-002687-27-NL (EUCTR)	28/05/2020	18/05/2020	A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease	A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2	Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	778	Phase 3	United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
57	EUCTR2018-004346-42-BG (EUCTR)	28/05/2020	08/01/2020	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
58	EUCTR2019-002895-14-BG (EUCTR)	21/05/2020	23/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
59	EUCTR2018-004614-18-LT (EUCTR)	20/05/2020	25/11/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
60	EUCTR2019-001673-93-DE (EUCTR)	19/05/2020	02/03/2020	A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.	An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolilmab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	NCT04362254 (ClinicalTrials.gov)	May 15, 2020	23/4/2020	A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials	An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Fistulising Crohn's Disease Who Have Completed Previous Spesolimab Trials	Crohn Disease	Drug: Spesolimab	Boehringer Ingelheim	NULL	Recruiting	18 Years	N/A	All	20	Phase 2	Austria;Germany
62	EUCTR2019-002895-14-ES (EUCTR)	14/05/2020	15/05/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
63	NCT04372108 (ClinicalTrials.gov)	May 14, 2020	30/4/2020	A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease	An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database	Crohn Disease	Drug: Ustekinumab;Drug: Other Biologic Therapies	Janssen Scientific Affairs, LLC	NULL	Recruiting	18 Years	N/A	All	1536		United States
64	EUCTR2019-000176-41-HU (EUCTR)	07/05/2020	16/03/2020	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071	Otsuka Pharmaceutical Development & Commercialization, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy
65	EUCTR2019-000886-19-AT (EUCTR)	06/05/2020	06/09/2019	A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection	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 Recurrence	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018	Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United States;France;Austria;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2019-000333-39-BE (EUCTR)	04/05/2020	21/01/2020	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula	A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
67	EUCTR2019-002895-14-NO (EUCTR)	04/05/2020	20/12/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;Belarus;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
68	ChiCTR2000031344	2020-05-01	2020-03-28	Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study	Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study	Crohn's disease	Group 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection;	The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine	NULL	Pending			Both	Group 1:35;Group 2:35;		China
69	EUCTR2019-002687-27-HU (EUCTR)	28/04/2020	09/03/2020	A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease	A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2	Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	778	Phase 3	United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
70	EUCTR2019-004219-29-NL (EUCTR)	21/04/2020	04/02/2020	Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s Disease	Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ	Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Azithromycin Product Name: Azithromycin INN or Proposed INN: Azithromycin Other descriptive name: AZITHROMYCIN Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: METRONIDAZOLE	Amsterdam UMC	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United States;Canada;Israel;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	NCT03905109 (ClinicalTrials.gov)	April 15, 2020	3/4/2019	Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease	A 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 Treatment	Crohn Disease	Drug: ABX464;Drug: Placebo	Abivax S.A.	NULL	Not yet recruiting	18 Years	75 Years	All	30	Phase 2	Belgium
72	EUCTR2018-004346-42-BE (EUCTR)	15/04/2020	03/03/2020	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
73	NCT04225819 (ClinicalTrials.gov)	April 1, 2020	3/1/2020	Adjunctive Treatment With Vitamin D3 in Patients With Active IBD	Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial	IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency	Dietary Supplement: Vitamin D3;Other: Placebo	Massachusetts General Hospital	NULL	Not yet recruiting	18 Years	N/A	All	100	N/A	NULL
74	EUCTR2018-004346-42-HU (EUCTR)	25/03/2020	31/01/2020	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
75	EUCTR2018-004346-42-CZ (EUCTR)	24/03/2020	22/01/2020	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2019-001337-13-FR (EUCTR)	18/03/2020	02/03/2020	USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study	USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP	patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: STELARA Trade Name: STELARA 90 mg solution for injection in pre-filled syringe	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	146	Phase 4	France
77	EUCTR2018-002629-51-GB (EUCTR)	16/03/2020	08/01/2020	A 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 Tract	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER)	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	France;United States;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
78	EUCTR2017-002491-10-CZ (EUCTR)	10/03/2020	27/11/2019	Postauthorization Safety Study of Darvadstrocel Repeat Administration	Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 4	France;Czech Republic;Spain;Austria;Germany;United Kingdom
79	NCT03492944 (ClinicalTrials.gov)	March 6, 2020	12/2/2018	Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason	Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography	Crohn Disease	Drug: Ultrasound Microbubble Contrast Agent;Device: Ultrasound Imaging	Children's Hospital Medical Center, Cincinnati	NULL	Recruiting	10 Years	18 Years	All	25		United States
80	EUCTR2019-000886-19-NL (EUCTR)	06/03/2020	17/09/2019	A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection	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 Recurrence	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018	Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United States;France;Austria;Germany;Netherlands;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2017-001976-48-FR (EUCTR)	06/03/2020	09/07/2018	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 2	United States;Portugal;Taiwan;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;China;Japan;Korea, Republic of
82	NCT04188990 (ClinicalTrials.gov)	March 5, 2020	2/12/2019	Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition	Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition	Pancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal Cancer	Dietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current care	Hospital Galdakao-Usansolo	NULL	Not yet recruiting	18 Years	N/A	All	900	N/A	NULL
83	ChiCTR2000029323	2020-03-01	2020-01-25	Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial	Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial	Crohn's disease	Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab;	Renji Hospital, School of Medicine, Shanghai Jiaotong University	NULL	Pending	18	80	Both	Experimental group:30;Control group:30;		China
84	NCT04014517 (ClinicalTrials.gov)	March 1, 2020	8/7/2019	Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients	Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients	Crohn Disease	Other: Standard of Care;Dietary Supplement: Immunonutrition	Istituto Clinico Humanitas	NULL	Not yet recruiting	18 Years	N/A	All	350	N/A	NULL
85	EUCTR2019-002895-14-SK (EUCTR)	26/02/2020	10/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2018-004614-18-LV (EUCTR)	19/02/2020	12/12/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
87	EUCTR2019-002895-14-FR (EUCTR)	17/02/2020	08/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States
88	NCT04254783 (ClinicalTrials.gov)	February 16, 2020	3/2/2020	A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease	A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis (UC);Crohn's Disease	Drug: Risankizumab;Drug: Cytochrome P450 (CYP) Substrates	AbbVie	NULL	Recruiting	18 Years	80 Years	All	20	Phase 1	United States;Germany;Israel
89	EUCTR2019-002895-14-LT (EUCTR)	13/02/2020	19/12/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
90	NCT04173273 (ClinicalTrials.gov)	February 12, 2020	20/11/2019	A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease	A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease	Crohn's Disease	Drug: Etrasimod;Drug: Placebo	Arena Pharmaceuticals	NULL	Recruiting	18 Years	80 Years	All	1265	Phase 2;Phase 3	United States;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	EUCTR2019-000176-41-IT (EUCTR)	11/02/2020	05/11/2020	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment - -	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OPS-2071 Product Code: [OPS-2071] INN or Proposed INN: OPS-2071 Product Name: OPS-2071 Product Code: [OPS-2071] INN or Proposed INN: OPS-2071 Product Name: OPS-2071 Product Code: [OPS-2071] INN or Proposed INN: OPS-2071	Otsuka Pharmaceutical Development and Commercialization, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Hungary;Canada;Poland;Belgium;Germany;Italy
92	ChiCTR2000029543	2020-02-08	2020-02-03	A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease	A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease	Crohn's Disease	Gold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines;	The First Hospital Affiliated to Sun Yat sen University	NULL	Recruiting			Both	Target condition:350;Difficult condition:0		China
93	NCT03999580 (ClinicalTrials.gov)	February 7, 2020	24/6/2019	The 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 Children	Crohn Disease	Drug: vitamin D3	Jantchou Prevost	NULL	Recruiting	4 Years	18 Years	All	316	Phase 3	Canada
94	EUCTR2019-001673-93-AT (EUCTR)	05/02/2020	13/12/2019	A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.	An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials	Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
95	NCT03950336 (ClinicalTrials.gov)	February 4, 2020	13/5/2019	Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease Patients	Influence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's Patients	Healthy First Degree Relatives of Crohn's Disease Patients	Dietary Supplement: Prebiotics;Other: Low n-6 PUFA Diet;Dietary Supplement: Maltodextrin;Other: Control Diet	University of Alberta	NULL	Recruiting	15 Years	50 Years	All	32	N/A	Canada
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2019-002895-14-HU (EUCTR)	03/02/2020	04/02/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Switzerland;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
97	NCT03961815 (ClinicalTrials.gov)	February 3, 2020	8/5/2019	Open-label Extension Study of Brazikumab in Crohn's Disease	An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	Crohn's Disease	Drug: Brazikumab	Allergan	NULL	Enrolling by invitation	16 Years	80 Years	All	1000	Phase 3	United States
98	EUCTR2019-000852-32-NL (EUCTR)	30/01/2020	08/10/2019	A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.	A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study	Inflammatory Bowel Disease, Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Naltrexone hydrochloride	ErasmusMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	122	Phase 2	Netherlands
99	EUCTR2019-000886-19-FR (EUCTR)	20/01/2020	26/07/2019	A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection	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 Recurrence	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Millennium Pharmaceuticals, Inc (a wholly owned subsidiary	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	75	Phase 2	United States;France;Germany;United Kingdom
100	EUCTR2019-000176-41-PL (EUCTR)	17/01/2020	06/09/2019	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Otsuka Pharmaceutical Development & Commercialization, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Canada;Belgium;Poland;Germany;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2019-002895-14-GR (EUCTR)	14/01/2020	03/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
102	EUCTR2019-002895-14-CZ (EUCTR)	09/01/2020	09/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
103	NCT04224558 (ClinicalTrials.gov)	January 1, 2020	4/4/2018	Stem Cell Transplantation in Crohn's Disease	Autologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease	Crohn Disease	Drug: Mesna;Drug: Cyclophosphamide;Drug: Filgrastim;Procedure: Apheresis catheter placement;Procedure: Leukapheresis;Drug: Fludarabine;Drug: Methylprednisolone;Drug: Diphenhydramine;Drug: Acetaminophen;Drug: anti-thymocyte globulin (rabbit);Drug: lymphocyte immune globulin;Biological: Peripheral Blood Stem Cell Infusion;Drug: Cytoxan	Cedars-Sinai Medical Center	NULL	Not yet recruiting	16 Years	24 Years	All	15	Phase 1;Phase 2	United States
104	NCT04239248 (ClinicalTrials.gov)	January 2020	27/11/2019	Tasty&Healthy Dietary Approach for Crohn's Disease	Tasty&Healthy is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's Disease	Crohn Disease	Dietary Supplement: Tasty&Healthy intervention group;Dietary Supplement: EEN intervention group	Shaare Zedek Medical Center	NULL	Not yet recruiting	6 Years	24 Years	All	192	N/A	Israel
105	NCT04233463 (ClinicalTrials.gov)	January 2020	15/1/2020	The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease	The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized Study	Crohn Disease	Dietary Supplement: Modulen;Drug: Budesonide	Hillel Yaffe Medical Center	NULL	Not yet recruiting	18 Years	70 Years	All	50	N/A	Israel
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2018-004346-42-ES (EUCTR)	26/12/2019	11/11/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden
107	EUCTR2019-003662-40-DE (EUCTR)	18/12/2019	22/10/2019	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED	MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	82	Phase 4	Germany
108	EUCTR2017-001976-48-PT (EUCTR)	16/12/2019	22/05/2019	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 2	Portugal;United States;Taiwan;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;Japan;China;Korea, Republic of
109	EUCTR2018-005086-39-HR (EUCTR)	16/12/2019	17/01/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
110	EUCTR2019-003816-29-FR (EUCTR)	16/12/2019	14/10/2019	Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal	Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal - MIRACLE	Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2018-004346-42-DE (EUCTR)	10/12/2019	17/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
112	EUCTR2017-004294-14-FR (EUCTR)	02/12/2019	09/02/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
113	NCT03915262 (ClinicalTrials.gov)	December 2, 2019	9/4/2019	Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease	Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy	Crohn Disease	Biological: Search for exocrine pancreatic insufficiency at week 0 and 12	Hospices Civils de Lyon	NULL	Recruiting	18 Years	N/A	All	50		France
114	NCT04134065 (ClinicalTrials.gov)	December 1, 2019	17/10/2019	the Effect of Vitamin D in Crohn's Disease	the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease	Vitamin D Deficiency;Crohn Disease	Drug: Vitamin D;Drug: Placebo oral capsule	Nanjing University School of Medicine	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Not yet recruiting	20 Years	60 Years	All	30	Early Phase 1	NULL
115	NCT02677350 (ClinicalTrials.gov)	December 1, 2019	1/2/2016	AlloGeneic 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 Cells	Drug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)	Joshua M Hare	NULL	Withdrawn	18 Years	N/A	All	0	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	EUCTR2019-001087-30-AT (EUCTR)	28/11/2019	12/09/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan
117	EUCTR2017-001240-35-SI (EUCTR)	27/11/2019	12/11/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
118	EUCTR2019-000886-19-DE (EUCTR)	26/11/2019	29/07/2019	A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection	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 Recurrence	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018	Millennium Pharmaceuticals, Inc (A wholly owned subsidiary of Takeda Pharmaceutical Company Limited)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United States;France;Austria;Netherlands;Germany;United Kingdom
119	EUCTR2018-001895-39-HR (EUCTR)	21/11/2019	20/01/2020	A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease	A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2	Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]		Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	258	Phase 2	Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
120	EUCTR2019-003068-39-NL (EUCTR)	20/11/2019	04/11/2019	In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.	Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study	Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	UMC Utrecht	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2017-004293-33-FR (EUCTR)	12/11/2019	09/02/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Serbia;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
122	EUCTR2018-002629-51-AT (EUCTR)	12/11/2019	27/06/2019	A 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 Tract	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER)	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	France;United States;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
123	ChiCTR1900027370	2019-11-11	2019-11-10	The pathogenic genes and flora of Crohn's disease with anal fistula	The pathogenic genes and flora of Crohn's disease with anal fistula	Crohn's disease with anal fistula	CD anal fistula and CD without anal fistula:N/A;	Nanfang Hospital, Southern Medical University	NULL	Recruiting			Both	CD anal fistula and CD without anal fistula:50;	N/A	China
124	EUCTR2019-001087-30-HR (EUCTR)	11/11/2019	17/01/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
125	EUCTR2019-000886-19-GB (EUCTR)	06/11/2019	29/07/2019	A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection	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 Recurrence - TAK-018 for Prevention of the Recurrence of Postoperative Crohn’s Disease	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018	Millennium Pharmaceuticals, Inc (a wholly owned subsidiary	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United States;France;Austria;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2017-004292-31-FR (EUCTR)	05/11/2019	09/08/2019	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Belarus;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
127	EUCTR2018-004346-42-FR (EUCTR)	05/11/2019	10/07/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden
128	NCT04075825 (ClinicalTrials.gov)	November 4, 2019	22/8/2019	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study	Crohn's Disease;Complex Perianal Fistula	Biological: Darvadstrocel	Millennium Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	N/A	All	150	Phase 3	United States;Belgium;Czechia;France;Hungary;Israel;Italy;Poland;Spain
129	NCT04154735 (ClinicalTrials.gov)	November 2019	8/3/2019	Autologous Transplant Targeted Against Crohn's	Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease	Crohn's Disease	Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: Tacrolimus	Northwestern University	NULL	Withdrawn	18 Years	49 Years	All	0	Phase 2	United States
130	EUCTR2019-001087-30-DE (EUCTR)	31/10/2019	01/07/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2019-001087-30-BG (EUCTR)	30/10/2019	24/10/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
132	NCT03945019 (ClinicalTrials.gov)	October 28, 2019	8/5/2019	CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease	Crohn's Disease	Biological: CT-P13 SC (Infliximab);Other: Placebo SC	Celltrion	NULL	Recruiting	18 Years	75 Years	All	600	Phase 3	United States
133	EUCTR2018-005086-39-HU (EUCTR)	28/10/2019	08/04/2019	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
134	NCT03962998 (ClinicalTrials.gov)	October 27, 2019	22/5/2019	Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability	A 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 Disease	Crohn Disease	Drug: Lactulose /Rhamnose solution;Drug: MB-102	MediBeacon	NULL	Recruiting	18 Years	N/A	All	20	Early Phase 1	United States
135	EUCTR2019-002093-32-SE (EUCTR)	24/10/2019	28/06/2019	A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.	Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease.	None. Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial. Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated. MedDRA version: 20.1;Level: LLT;Classification code 10011603;Term: CT scan;System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]		Lument AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 2	Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	EUCTR2018-004614-18-NL (EUCTR)	21/10/2019	27/06/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
137	EUCTR2018-004614-18-DE (EUCTR)	15/10/2019	25/06/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
138	EUCTR2019-000333-39-CZ (EUCTR)	15/10/2019	03/09/2019	Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 INN or Proposed INN: DARVADSTROCEL Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	Millennium Pharmaceuticals, Inc (MPI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
139	EUCTR2017-004295-55-FR (EUCTR)	08/10/2019	09/02/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
140	EUCTR2018-005086-39-PL (EUCTR)	07/10/2019	06/05/2019	A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	NCT04131322 (ClinicalTrials.gov)	October 2019	10/10/2019	Loss 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 Study	Crohn Disease;Ulcerative Colitis	Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	NULL	Not yet recruiting	18 Years	N/A	All	216	Phase 4	NULL
142	EUCTR2018-001895-39-NL (EUCTR)	27/09/2019	03/06/2019	A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease	A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2	Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]		Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	258	Phase 2	Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany
143	NCT04102111 (ClinicalTrials.gov)	September 23, 2019	23/9/2019	A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease	Crohn Disease	Drug: JNJ-67864238;Drug: Placebo	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	75 Years	All	90	Phase 2	United States;Argentina;France;Germany;Italy;Poland;Russian Federation;Ukraine
144	ChiCTR1900026091	2019-09-19	2019-09-20	Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease	Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study	Crohn's disease	Case series:infliximab;	The First Affiliated Hospital of Sun Yat-sen University	NULL	Pending	9	58	Both	Case series:343;		China
145	EUCTR2018-004614-18-GB (EUCTR)	16/09/2019	20/06/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2018-004614-18-ES (EUCTR)	12/09/2019	04/07/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	Moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Lilly S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
147	EUCTR2018-004614-18-FR (EUCTR)	11/09/2019	20/06/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
148	EUCTR2018-004346-42-GB (EUCTR)	10/09/2019	30/05/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598 Trade Name: Humira ® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
149	NCT03885713 (ClinicalTrials.gov)	September 10, 2019	4/3/2019	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	NULL	Recruiting	18 Years	N/A	All	180	Phase 4	Spain
150	EUCTR2017-004588-11-NL (EUCTR)	10/09/2019	10/09/2019	Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.	Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial	The Chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Maastricht University Medical Centre	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	146	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2019-001087-30-PL (EUCTR)	09/09/2019	24/06/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
152	EUCTR2018-001895-39-BG (EUCTR)	05/09/2019	16/07/2019	A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease	A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2	Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]		Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	258	Phase 2	Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
153	EUCTR2019-001948-21-FR (EUCTR)	03/09/2019	15/05/2019	Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas.	Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas. - ADICROHN-II	Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: autologous ADIpose derived stromal vascular fraction Product Code: ADSVF Trade Name: vialebex 200mg Product Name: VIALEBEX Product Code: SERUM ALBUMINE 5% INN or Proposed INN: ALBUMINE HUMAINE Other descriptive name: HUMAN ALBUMIN AS MACROAGGREGATES Trade Name: serum physiologique 0.9 % Product Name: chlorure de sodium INN or Proposed INN: CHLORURE DE SODIUM Other descriptive name: SODIUM CHLORIDE	ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 2	France
154	EUCTR2018-004614-18-PL (EUCTR)	03/09/2019	09/07/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
155	EUCTR2019-001087-30-GR (EUCTR)	28/08/2019	26/07/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	EUCTR2019-001087-30-ES (EUCTR)	14/08/2019	10/09/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
157	EUCTR2019-001087-30-FR (EUCTR)	13/08/2019	14/06/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
158	EUCTR2019-001087-30-HU (EUCTR)	09/08/2019	10/08/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
159	EUCTR2019-001087-30-CZ (EUCTR)	06/08/2019	06/06/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSINA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
160	EUCTR2018-002629-51-FR (EUCTR)	31/07/2019	24/04/2019	A 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 Tract	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER)	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;France;Spain;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2019-001087-30-LV (EUCTR)	25/07/2019	04/06/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
162	EUCTR2018-004614-18-HU (EUCTR)	25/07/2019	11/06/2019	Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1	moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1100	Phase 3	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
163	NCT03926130 (ClinicalTrials.gov)	July 23, 2019	23/4/2019	A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease	Crohn's Disease	Drug: Mirikizumab;Drug: Ustekinumab;Drug: Placebo	Eli Lilly and Company	NULL	Recruiting	15 Years	80 Years	All	1150	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
164	EUCTR2017-000725-12-DE (EUCTR)	17/07/2019	28/02/2019	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
165	EUCTR2016-003191-50-FR (EUCTR)	17/07/2019	28/01/2019	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	959	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	EUCTR2017-001226-18-SI (EUCTR)	15/07/2019	06/03/2019	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
167	NCT04056442 (ClinicalTrials.gov)	July 7, 2019	13/8/2019	A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients	A Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients	Steroid Dependent Crohn's Disease	Drug: Cannabidiol , synthetic form;Drug: Placebo	Stero Biotechs Ltd.	NULL	Recruiting	18 Years	N/A	All	28	Phase 2	Israel
168	ChiCTR1900023696	2019-07-01	2019-06-08	Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial	Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial	Chron's disease	Group 1:EBD;Group 2:EBD combined with local injection of betamethasone;	The Sixth Affiliated Hospital of Sun Yat-sen University	NULL	Pending	18	75	Both	Group 1:45;Group 2:45;	N/A	China
169	NCT03914261 (ClinicalTrials.gov)	July 1, 2019	11/4/2019	Expanded Access to Risankizumab	Expanded Access to Risankizumab	Crohn's Disease;Ulcerative Colitis (UC)	Drug: Risankizumab	AbbVie	NULL	Available	18 Years	N/A	All			Belgium;Israel;Spain;Switzerland;United States
170	JPRN-JapicCTI-194830	01/7/2019	27/06/2019	Specified 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 disease	Intervention 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 Limited	NULL	pending			BOTH	300	NA	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	NCT04002180 (ClinicalTrials.gov)	July 1, 2019	26/6/2019	Specified 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 Disease	Drug: Vedolizumab (Genetical Recombination)	Takeda	NULL	Recruiting	N/A	N/A	All	300		Japan
172	NCT04089514 (ClinicalTrials.gov)	June 30, 2019	12/9/2019	A Real-world Study of Imraldi® Use	Pan-EU Real-World Experience With Imraldi®	Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC)	Drug: Adalimumab	Biogen	NULL	Recruiting	18 Years	N/A	All	1400		Germany;United Kingdom
173	EUCTR2019-002038-35-BE (EUCTR)	27/06/2019	07/06/2019	A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients	A prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Stelara INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB	UZ Leuven	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Belgium
174	EUCTR2019-000717-37-ES (EUCTR)	27/06/2019	28/06/2019	Loss of response of the Adalimumba biosimilar compared with the original drug	LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY. ADA-SWITCH Study - ADA-SWITCH Study	Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	136	Phase 4	Spain
175	EUCTR2017-004997-32-DE (EUCTR)	25/06/2019	14/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	NCT04254549 (ClinicalTrials.gov)	June 14, 2019	3/2/2020	Rifaximin in Patients With Diabetic Gastroparesis	Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.	Crohn Disease;Diabetic Gastroparesis	Drug: Rifaximin;Drug: Placebo	Mayo Clinic	NULL	Recruiting	18 Years	75 Years	All	40	Phase 2	United States
177	EUCTR2017-002195-13-GB (EUCTR)	05/06/2019	28/02/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
178	NCT03941418 (ClinicalTrials.gov)	June 1, 2019	5/5/2019	Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease	Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease	Ulcerative Colitis;Crohn Disease	Dietary Supplement: Boulardii;Dietary Supplement: Placebo	University Clinic Dr Dragisa Misovic-Dedinje	University Clinic Zvezdara	Not yet recruiting	18 Years	80 Years	All	150	N/A	NULL
179	NCT03677648 (ClinicalTrials.gov)	May 14, 2019	17/9/2018	A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease	A 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 Disease	Crohn's Disease	Drug: SHR0302;Drug: Placebos	Reistone Biopharma Company Limited	NULL	Recruiting	18 Years	75 Years	All	144	Phase 2	United States;China;Poland;Ukraine
180	EUCTR2017-003090-34-HU (EUCTR)	10/05/2019	25/03/2019	A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD	Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Phase 2	Hungary;Belgium;Austria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	EUCTR2016-003190-17-FR (EUCTR)	07/05/2019	14/03/2019	A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	579	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
182	ChiCTR1900022728	2019-05-01	2019-04-23	Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease	Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease	Crohn's disease	Gold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD;	The 7th Medical Center of the PLA General Hospital (Army general hospital)	NULL	Pending			Both	Target condition:310;Difficult condition:160		China
183	EUCTR2018-004967-30-GB (EUCTR)	30/04/2019	14/01/2019	Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over Study	IBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS	Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Imraldi Product Name: Imraldi INN or Proposed INN: adalimumab Trade Name: Humira Product Name: Humira INN or Proposed INN: adalimumab	University Hospital Southampton NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	United Kingdom
184	EUCTR2018-003594-95-NL (EUCTR)	30/04/2019	30/04/2019	Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy	Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response	Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Amsterdam UMC location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	Netherlands
185	NCT03733314 (ClinicalTrials.gov)	April 25, 2019	5/11/2018	A Study of E6011 in Participants With Active Crohn's Disease	Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease	Crohn's Disease	Drug: E6011;Drug: Placebo	EA Pharma Co., Ltd.	NULL	Recruiting	18 Years	64 Years	All	40	Phase 2	Czechia;Hungary;Japan;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2018-002629-51-SE (EUCTR)	23/04/2019	29/01/2019	A 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 Tract	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER)	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;France;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
187	EUCTR2017-001225-41-SI (EUCTR)	19/04/2019	06/03/2019	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	738	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
188	EUCTR2017-000725-12-GB (EUCTR)	17/04/2019	22/10/2018	A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).	A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.	Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)	TiGenix, S.A.U.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	554	Phase 3	United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom
189	EUCTR2017-003090-34-NL (EUCTR)	16/04/2019	19/12/2018	A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD	Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Netherlands BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Phase 2	Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of
190	EUCTR2017-001976-48-DK (EUCTR)	15/04/2019	29/01/2019	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Bouvet Island;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	EUCTR2018-002109-70-HU (EUCTR)	15/04/2019	20/11/2018	A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel disease	Early phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable	Active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		EA Pharma Co., Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Czech Republic;Hungary;Poland;Japan
192	EUCTR2018-002064-15-NL (EUCTR)	15/04/2019	15/04/2019	Patient preference model: treatment of perianal fistulas in Crohn's disease	Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial	Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab	Academic Medical Center	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 4	Netherlands
193	NCT03942120 (ClinicalTrials.gov)	April 8, 2019	7/5/2019	Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)	Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA	Crohn Disease	Drug: Ustekinumab	Janssen Korea, Ltd., Korea	NULL	Recruiting	18 Years	N/A	All	70		Korea, Republic of
194	EUCTR2018-001272-37-HR (EUCTR)	05/04/2019	17/05/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
195	NCT03816345 (ClinicalTrials.gov)	April 4, 2019	24/1/2019	Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer	A 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 Neoplasm	Biological: Nivolumab	National Cancer Institute (NCI)	NULL	Recruiting	18 Years	N/A	All	264	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	NCT03712826 (ClinicalTrials.gov)	April 2019	16/8/2018	Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease	Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease	Crohn Disease	Drug: Anti-TNF Drug;Drug: Ustekinumab	Hospices Civils de Lyon	NULL	Recruiting	18 Years	N/A	All	60	N/A	France
197	NCT03884439 (ClinicalTrials.gov)	March 18, 2019	4/3/2019	Infliximab 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 Colitis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	300		Japan
198	EUCTR2017-002195-13-PT (EUCTR)	18/03/2019	23/07/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
199	EUCTR2018-003303-19-PL (EUCTR)	15/03/2019	23/01/2019	A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.	A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease.	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Reistone Biopharma Company Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 2	United States;Poland;Ukraine;China
200	EUCTR2017-001226-18-IE (EUCTR)	08/03/2019	05/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	EUCTR2017-001225-41-IE (EUCTR)	08/03/2019	13/03/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
202	EUCTR2017-001240-35-IE (EUCTR)	08/03/2019	05/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
203	NCT03706456 (ClinicalTrials.gov)	March 6, 2019	11/10/2018	Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease	A 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 Disease	Complex Perianal Fistulas in Adult Patients With Crohn's Disease	Biological: Darvadstrocel	Takeda	NULL	Active, not recruiting	18 Years	N/A	All	22	Phase 3	Japan
204	NCT03901937 (ClinicalTrials.gov)	March 1, 2019	12/3/2019	The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease	Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China	Crohn Disease	Drug: ?-3 polyunsaturated fatty acid;Procedure: Intestinal surgery for Crohn's Disease	Sir Run Run Shaw Hospital	NULL	Recruiting	18 Years	75 Years	All	158	Phase 4	China
205	EUCTR2017-000617-23-GB (EUCTR)	28/02/2019	11/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	EUCTR2017-000575-88-GB (EUCTR)	28/02/2019	11/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1032	Phase 3	Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
207	EUCTR2017-000574-11-GR (EUCTR)	26/02/2019	27/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
208	EUCTR2017-000576-29-GR (EUCTR)	26/02/2019	25/02/2019	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
209	EUCTR2017-000617-23-GR (EUCTR)	26/02/2019	21/02/2019	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
210	EUCTR2018-001272-37-PT (EUCTR)	25/02/2019	30/07/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	EUCTR2018-001272-37-AT (EUCTR)	25/02/2019	21/09/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
212	EUCTR2017-003090-34-DE (EUCTR)	18/02/2019	15/11/2018	A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD	Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Phase 2	Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Denmark;Austria
213	EUCTR2016-005199-90-SK (EUCTR)	14/02/2019	14/02/2018	Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease.	An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study - RHB-104-04 and MAP (US2)	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		RedHill Biopharma Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Australia;Israel;New Zealand
214	NCT03681652 (ClinicalTrials.gov)	February 11, 2019	20/9/2018	Post-Operative Crohn's Disease Outcome in Children	Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study	Crohn Disease	Drug: Azathioprine;Drug: Anti-TNF Drug	Schneider Children's Medical Center, Israel	NULL	Recruiting	6 Years	18 Years	All	100		Israel
215	NCT03627091 (ClinicalTrials.gov)	February 6, 2019	24/7/2018	Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)	Crohn's Disease	Drug: Ontamalimab;Other: Placebo	Shire	NULL	Active, not recruiting	16 Years	80 Years	All	40	Phase 3	Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;United States;Australia;Argentina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	EUCTR2017-003090-34-AT (EUCTR)	05/02/2019	11/10/2018	A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD	Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Phase 2	Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
217	NCT03752970 (ClinicalTrials.gov)	February 5, 2019	22/11/2018	A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease	Crohn Disease	Drug: Spesolimab;Drug: Placebo	Boehringer Ingelheim	NULL	Recruiting	18 Years	75 Years	All	28	Phase 2	Austria;Belgium;Germany;Hungary;Korea, Republic of;Netherlands;Spain
218	EUCTR2017-004997-32-HU (EUCTR)	04/02/2019	04/04/2019	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
219	EUCTR2017-004295-55-PT (EUCTR)	04/02/2019	01/10/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
220	EUCTR2017-004997-32-NL (EUCTR)	30/01/2019	06/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	EUCTR2016-000634-21-FR (EUCTR)	28/01/2019	08/11/2018	A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease	A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	693	Phase 2	United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
222	NCT03650413 (ClinicalTrials.gov)	January 14, 2019	16/8/2018	An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis;Crohn's Disease	Drug: UTTR1147A	Genentech, Inc.	NULL	Recruiting	18 Years	80 Years	All	320	Phase 2	United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France
223	EUCTR2017-000575-88-HR (EUCTR)	11/01/2019	16/05/2019	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Serbia;Czechia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
224	EUCTR2017-000617-23-HR (EUCTR)	11/01/2019	16/05/2019	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
225	EUCTR2018-001272-37-FR (EUCTR)	10/01/2019	23/07/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	EUCTR2018-002629-51-NL (EUCTR)	08/01/2019	12/11/2018	A 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 Tract	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER)	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	France;United States;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
227	EUCTR2017-004997-32-GB (EUCTR)	04/01/2019	09/10/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
228	NCT04606017 (ClinicalTrials.gov)	January 1, 2019	25/10/2020	Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response in Patients With Crohn's Disease	Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response	Crohn Disease;Vitamin D Deficiency;Vitamin D Supplement	Drug: Caltrate Pill	Second Affiliated Hospital of Wenzhou Medical University	NULL	Completed	N/A	N/A	All	70		China
229	NCT03773237 (ClinicalTrials.gov)	December 31, 2018	12/11/2018	Intralipid Versus SMOFlipid in HPN Patients	Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.	Short Bowel Syndrome;Intestinal Fistula;Crohn Disease;Intestinal Obstruction	Dietary Supplement: SMOFLipid;Dietary Supplement: Intralipid	Mayo Clinic	NULL	Recruiting	18 Years	75 Years	All	100	N/A	United States
230	EUCTR2017-001225-41-HR (EUCTR)	31/12/2018	21/05/2019	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	EUCTR2018-002925-47-ES (EUCTR)	28/12/2018	16/11/2018	prediction of response to therapy in inflammatory bowel disease	Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches	Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Fundación de Investigación Biomédica del Hospital Universitario de La Princesa	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 4	Spain
232	EUCTR2017-001976-48-DE (EUCTR)	20/12/2018	22/08/2018	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Portugal;Czechia;Taiwan;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
233	EUCTR2017-001240-35-HR (EUCTR)	20/12/2018	21/05/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
234	NCT03782376 (ClinicalTrials.gov)	December 20, 2018	11/12/2018	A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease	A 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	Crohn Disease	Drug: 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 2	Janssen-Cilag Ltd.	NULL	Recruiting	18 Years	N/A	All	200	Phase 3	United States;Austria;France;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
235	EUCTR2017-001226-18-HR (EUCTR)	19/12/2018	21/05/2019	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	ChiCTR1800019958	2018-12-16	2018-12-09	Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease	Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease	Crohn's disease	Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;	Daping Hospital, Army Medical University (Third Military Medical University)	NULL	Recruiting	18	65	Both	Case series:60;		China
237	EUCTR2017-004997-32-IE (EUCTR)	14/12/2018	13/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
238	EUCTR2018-002001-65-GB (EUCTR)	13/12/2018	01/10/2018	A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s Disease	A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		University of Birmingham	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 1	United Kingdom
239	EUCTR2017-004295-55-BE (EUCTR)	13/12/2018	30/03/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
240	EUCTR2018-002629-51-ES (EUCTR)	12/12/2018	16/11/2018	A 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 Tract	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER)	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	France;United States;Spain;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
241	EUCTR2017-004997-32-ES (EUCTR)	10/12/2018	17/09/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Roche Farma, S.A por delegación de Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
242	NCT03759288 (ClinicalTrials.gov)	December 7, 2018	20/11/2018	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease	Crohn's Disease;IBD	Drug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira ®;Drug: Placebo	Allergan	NULL	Recruiting	16 Years	80 Years	All	1140	Phase 2;Phase 3	United States;Canada;Puerto Rico
243	NCT03574948 (ClinicalTrials.gov)	December 6, 2018	22/6/2018	5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores	Multicentric, 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 Scores	Crohn Disease;Ulcerative Colitis;Fatigue;Remission	Drug: 5-HTP;Drug: Placebo oral capsule	University Hospital, Ghent	NULL	Recruiting	18 Years	60 Years	All	180	Phase 2	Belgium
244	EUCTR2018-001272-37-DE (EUCTR)	04/12/2018	26/07/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
245	EUCTR2017-004294-14-DK (EUCTR)	30/11/2018	27/08/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
246	EUCTR2017-004295-55-DK (EUCTR)	30/11/2018	27/08/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
247	EUCTR2017-003090-34-BE (EUCTR)	28/11/2018	12/10/2018	A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease	Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD	Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	SCS Boehringer Ingelheim Comm.V	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Phase 2	Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
248	EUCTR2018-001272-37-GR (EUCTR)	28/11/2018	09/11/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma US, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany;Serbia
249	EUCTR2017-001976-48-ES (EUCTR)	23/11/2018	17/07/2018	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 2	United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
250	NCT03635112 (ClinicalTrials.gov)	November 19, 2018	31/7/2018	Efficacy and Safety of TD-1473 in Crohn's Disease	A 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	Crohn's Disease	Drug: Placebo;Drug: TD-1473	Theravance Biopharma	NULL	Recruiting	18 Years	N/A	All	160	Phase 2	United States;Australia;Austria;Bulgaria;Croatia;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
251	EUCTR2018-001272-37-GB (EUCTR)	15/11/2018	03/10/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - DIONE - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
252	EUCTR2017-000617-23-DE (EUCTR)	13/11/2018	28/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan
253	NCT03623932 (ClinicalTrials.gov)	November 13, 2018	4/7/2018	Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease	Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease	Crohn Disease	Drug: immunosuppressor/TNFalpha;Behavioral: Hypnosis	University Hospital, Grenoble	NULL	Recruiting	18 Years	65 Years	All	40	N/A	France
254	EUCTR2017-000575-88-DE (EUCTR)	13/11/2018	28/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan;Lithuania;Austria;Russian Federation;Israel;United States;Serbia
255	EUCTR2018-001272-37-ES (EUCTR)	11/11/2018	09/08/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
256	EUCTR2017-004293-33-SI (EUCTR)	06/11/2018	12/02/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
257	EUCTR2017-004295-55-SI (EUCTR)	06/11/2018	13/02/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
258	EUCTR2017-004294-14-SI (EUCTR)	06/11/2018	13/02/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	485	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
259	EUCTR2015-003759-23-NO (EUCTR)	02/11/2018	07/12/2020	A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease	A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand
260	EUCTR2018-001382-17-GB (EUCTR)	30/10/2018	24/06/2019	An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.	Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial - STATIC	Inactive Crohn’s Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	INN or Proposed INN: MESALAZINE	Alimentiv Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1580	Phase 4	Canada;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
261	EUCTR2017-004294-14-PT (EUCTR)	29/10/2018	16/07/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	485	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
262	EUCTR2017-005151-83-DE (EUCTR)	26/10/2018	09/07/2018	Treatment of Crohn's disease with Ustekinumab in clinical practice	INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUS	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: STELARA Product Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA Product Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Charité Universitätsmedizin Berlin	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	Germany
263	EUCTR2017-004209-41-BE (EUCTR)	25/10/2018	21/08/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
264	NCT03723447 (ClinicalTrials.gov)	October 23, 2018	26/10/2018	Intraoperative 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 Trial	Pain, Postoperative;Crohn Disease;Inflammatory Bowel Diseases;Colorectal Cancer;Gastrointestinal Cancer;Gastrointestinal Disease;Digestive System Disease;Pain;Pain, Neuropathic;Intestinal Disease	Drug: Liposomal bupivacaine;Drug: Bupivacaine /epinephrine/dexamethasone	Cedars-Sinai Medical Center	NULL	Active, not recruiting	18 Years	90 Years	All	100	Phase 4	United States
265	EUCTR2017-004294-14-NL (EUCTR)	22/10/2018	12/03/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
266	EUCTR2017-004295-55-NL (EUCTR)	22/10/2018	12/03/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
267	EUCTR2017-004293-33-NL (EUCTR)	22/10/2018	12/03/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Serbia;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
268	EUCTR2018-001272-37-HU (EUCTR)	16/10/2018	16/08/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
269	EUCTR2017-004209-41-DE (EUCTR)	16/10/2018	21/06/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
270	EUCTR2017-004293-33-FI (EUCTR)	10/10/2018	30/07/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
271	EUCTR2017-004294-14-FI (EUCTR)	10/10/2018	30/07/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
272	EUCTR2017-004295-55-FI (EUCTR)	10/10/2018	31/07/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
273	EUCTR2018-001272-37-BG (EUCTR)	09/10/2018	31/08/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease	A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease	Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
274	EUCTR2017-000617-23-PT (EUCTR)	08/10/2018	01/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
275	EUCTR2017-000576-29-BE (EUCTR)	08/10/2018	02/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	EUCTR2017-000617-23-BE (EUCTR)	08/10/2018	02/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
277	EUCTR2017-003359-43-DE (EUCTR)	04/10/2018	19/04/2018	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	Turkey;Austria;Hungary;Czech Republic;Canada;Belgium;United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Poland;Croatia;Georgia;Germany
278	EUCTR2017-000617-23-EE (EUCTR)	03/10/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	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;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
279	EUCTR2017-000574-11-EE (EUCTR)	03/10/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	Serbia;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
280	EUCTR2017-004209-41-NL (EUCTR)	01/10/2018	27/06/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira ® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
281	EUCTR2017-004209-41-BG (EUCTR)	26/09/2018	19/07/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one year	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira ® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	United States;Serbia;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
282	NCT03606499 (ClinicalTrials.gov)	September 26, 2018	20/7/2018	Real-world Effectiveness of Ustekinumab in Participants Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases	Effectiveness of Ustekinumab in Patients Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-Mediated Inflammatory Diseases in a Real-world Setting	Crohn Disease	Drug: Ustekinumab	Janssen Cilag S.A.S.	NULL	Recruiting	18 Years	N/A	All	125		France
283	EUCTR2017-003359-43-AT (EUCTR)	24/09/2018	20/04/2018	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
284	EUCTR2017-004295-55-DE (EUCTR)	21/09/2018	21/02/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
285	EUCTR2017-004294-14-BE (EUCTR)	20/09/2018	28/03/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
286	JPRN-JapicCTI-183950	20/9/2018	07/05/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	Crohn's Disease	Intervention 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.	NULL	recruiting	18		BOTH	2000	Phase 2;Phase 3	Japan, North America
287	EUCTR2017-000617-23-NL (EUCTR)	17/09/2018	17/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	Serbia;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
288	EUCTR2017-000575-88-NL (EUCTR)	17/09/2018	19/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1032	Phase 3	Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
289	EUCTR2017-000617-23-BG (EUCTR)	14/09/2018	10/07/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
290	EUCTR2017-000576-29-BG (EUCTR)	14/09/2018	24/07/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
291	EUCTR2017-001240-35-BE (EUCTR)	13/09/2018	02/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
292	EUCTR2017-001976-48-HU (EUCTR)	13/09/2018	05/07/2018	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 2	United States;Portugal;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Romania;Australia;Denmark;Germany;Korea, Republic of
293	EUCTR2017-001226-18-BE (EUCTR)	13/09/2018	02/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
294	EUCTR2017-001225-41-BE (EUCTR)	13/09/2018	19/12/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
295	EUCTR2017-001226-18-CZ (EUCTR)	12/09/2018	19/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	EUCTR2017-001225-41-CZ (EUCTR)	12/09/2018	20/04/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
297	EUCTR2017-004292-31-BE (EUCTR)	10/09/2018	23/03/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
298	EUCTR2017-002195-13-NL (EUCTR)	10/09/2018	30/04/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Latvia;Tunisia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
299	EUCTR2017-002195-13-HR (EUCTR)	07/09/2018	16/05/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;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
300	EUCTR2017-004292-31-DE (EUCTR)	06/09/2018	06/02/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
301	NCT03615378 (ClinicalTrials.gov)	August 30, 2018	16/7/2018	Maintenance Dosing of Vitamin D in Crohn's Disease	A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission	Crohns Disease;Vitamin D Deficiency	Dietary Supplement: 5000 IU D3;Dietary Supplement: 1000 IU D3;Dietary Supplement: Placebo	Cedars-Sinai Medical Center	NULL	Terminated	18 Years	N/A	All	10	Early Phase 1	United States
302	EUCTR2017-000576-29-PT (EUCTR)	27/08/2018	01/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1032	Phase 3	Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
303	EUCTR2017-004209-41-CZ (EUCTR)	27/08/2018	13/06/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
304	NCT03452501 (ClinicalTrials.gov)	August 26, 2018	26/2/2018	Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients	An 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 CD	Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis	Drug: Infliximab	Hikma Pharmaceuticals LLC	NULL	Active, not recruiting	18 Years	N/A	All	150		Saudi Arabia
305	EUCTR2017-004209-41-GB (EUCTR)	24/08/2018	22/06/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira ® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
306	EUCTR2017-004294-14-DE (EUCTR)	23/08/2018	20/02/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	485	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
307	EUCTR2017-001976-48-GB (EUCTR)	23/08/2018	26/06/2018	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
308	EUCTR2017-001976-48-PL (EUCTR)	23/08/2018	17/07/2018	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE	Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
309	NCT03467958 (ClinicalTrials.gov)	August 22, 2018	12/3/2018	An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease	Crohn Disease	Drug: Ozanimod	Celgene	NULL	Recruiting	12 Years	75 Years	All	1200	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
310	EUCTR2017-001240-35-BG (EUCTR)	22/08/2018	05/06/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
311	EUCTR2017-001225-41-BG (EUCTR)	22/08/2018	05/06/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
312	EUCTR2017-001226-18-BG (EUCTR)	22/08/2018	05/06/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
313	NCT03546868 (ClinicalTrials.gov)	August 14, 2018	10/5/2018	Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease	Phase 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 Disease	Drug: [18F]FSPG	Asan Foundation	NULL	Completed	19 Years	79 Years	All	20	Phase 2	Korea, Republic of
314	EUCTR2017-002195-13-PL (EUCTR)	13/08/2018	25/05/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Georgia;Germany;New Zealand;Japan
315	EUCTR2017-002195-13-LV (EUCTR)	10/08/2018	21/05/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Tunisia;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
316	EUCTR2017-004294-14-SE (EUCTR)	08/08/2018	08/03/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
317	EUCTR2017-004295-55-SE (EUCTR)	08/08/2018	08/03/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
318	EUCTR2017-004293-33-PT (EUCTR)	06/08/2018	27/03/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn¿s Disease	Moderately to Severely Active Crohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
319	EUCTR2017-004209-41-PL (EUCTR)	03/08/2018	20/06/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
320	EUCTR2017-002195-13-ES (EUCTR)	30/07/2018	21/05/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
321	EUCTR2017-004209-41-FR (EUCTR)	30/07/2018	14/06/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira ® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Russian Federation;United Kingdom;Italy;Serbia;United States;Spain;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
322	EUCTR2017-002195-13-GR (EUCTR)	27/07/2018	17/07/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;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
323	EUCTR2017-000576-29-EE (EUCTR)	25/07/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
324	EUCTR2017-000617-23-HU (EUCTR)	24/07/2018	15/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	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;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
325	EUCTR2017-000576-29-HU (EUCTR)	24/07/2018	15/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
326	NCT03449069 (ClinicalTrials.gov)	July 23, 2018	22/2/2018	Pediatric MSC-AFP Sub-study for Crohn's Fistula	A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study	Fistula in Ano;Crohn Disease	Drug: MSC-AFP	Mayo Clinic	NULL	Recruiting	12 Years	17 Years	All	5	Phase 1	United States
327	EUCTR2016-003191-50-SE (EUCTR)	22/07/2018	14/09/2017	A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1250	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
328	EUCTR2017-003359-43-HR (EUCTR)	19/07/2018	16/05/2019	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease	Moderate To Severe Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
329	EUCTR2017-001737-85-NL (EUCTR)	17/07/2018	03/04/2018	Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy	Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy - ADD UP	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: albendazole (Eskazole) Product Name: albendazole	academic medical centre	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	Netherlands
330	EUCTR2017-000617-23-ES (EUCTR)	16/07/2018	14/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
331	EUCTR2017-004294-14-GB (EUCTR)	13/07/2018	26/06/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	485	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
332	EUCTR2017-004292-31-GB (EUCTR)	13/07/2018	26/06/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand
333	EUCTR2017-000576-29-ES (EUCTR)	11/07/2018	21/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
334	EUCTR2018-001546-33-GB (EUCTR)	11/07/2018	14/05/2018	The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease	IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0	Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab	University Southampton Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
335	EUCTR2017-000576-29-SK (EUCTR)	10/07/2018	17/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306	Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
336	EUCTR2017-000617-23-SK (EUCTR)	10/07/2018	17/05/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan
337	EUCTR2016-003123-32-SE (EUCTR)	09/07/2018	08/09/2017	A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	855	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
338	EUCTR2017-004292-31-DK (EUCTR)	09/07/2018	09/04/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
339	NCT03860571 (ClinicalTrials.gov)	July 6, 2018	3/2/2019	Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers	A 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 Volunteers	Ulcerative Colitis;Crohn Disease	Drug: BT-11 Placebo;Drug: BT-11 Active	Landos Biopharma Inc.	NULL	Completed	18 Years	65 Years	All	70	Phase 1	United States
340	EUCTR2017-000575-88-AT (EUCTR)	06/07/2018	19/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1032	Phase 3	United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
341	EUCTR2017-000617-23-AT (EUCTR)	06/07/2018	19/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
342	EUCTR2017-001240-35-LT (EUCTR)	05/07/2018	23/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
343	EUCTR2017-002195-13-DE (EUCTR)	03/07/2018	01/03/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;North Macedonia;Colombia;Italy;France;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan;Taiwan;Saudi Arabia;Slovakia
344	NCT03662919 (ClinicalTrials.gov)	July 2, 2018	6/9/2018	One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study	PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study	Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, Ulcerative	Drug: Infliximab;Drug: Adalimumab	Biogen	NULL	Recruiting	6 Years	N/A	All	3000		France
345	NCT03467620 (ClinicalTrials.gov)	July 2018	5/3/2018	Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease	Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study	Crohn Disease;Inflammatory Bowel Diseases;Cannabis	Drug: Cannabidiol;Drug: Placebo oral capsule	University of Illinois at Chicago	NULL	Withdrawn	18 Years	N/A	All	0	Phase 2;Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
346	NCT03599622 (ClinicalTrials.gov)	June 29, 2018	11/7/2018	An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease	Granulomatous Colitis;Crohn's Disease;Crohn's Enteritis;Granulomatous Enteritis	Drug: BMS-986165;Other: Placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	75 Years	All	240	Phase 2	United States;Australia;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom
347	EUCTR2017-002195-13-LT (EUCTR)	28/06/2018	20/04/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
348	EUCTR2017-001225-41-DK (EUCTR)	27/06/2018	07/02/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
349	NCT03464097 (ClinicalTrials.gov)	June 27, 2018	26/2/2018	A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease	Crohn Disease	Drug: Ozanimod;Other: Placebo	Celgene	NULL	Recruiting	12 Years	75 Years	All	485	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
350	EUCTR2017-000574-11-BE (EUCTR)	27/06/2018	14/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
351	EUCTR2017-001226-18-DE (EUCTR)	26/06/2018	09/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
352	EUCTR2017-001225-41-DE (EUCTR)	26/06/2018	08/02/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
353	EUCTR2017-003359-43-SK (EUCTR)	26/06/2018	19/04/2018	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Georgia;Germany
354	EUCTR2017-001240-35-DE (EUCTR)	26/06/2018	28/02/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
355	NCT03559517 (ClinicalTrials.gov)	June 25, 2018	9/5/2018	Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)	Crohn's Disease	Biological: Ontamalimab;Other: Placebo	Shire	NULL	Terminated	16 Years	80 Years	All	30	Phase 3	United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
356	NCT03472690 (ClinicalTrials.gov)	June 25, 2018	8/3/2018	QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease	A 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 Disease	Crohn Disease	Biological: QBECO-SSI;Other: Placebo	Qu Biologics Inc.	NULL	Active, not recruiting	18 Years	N/A	All	20	Phase 2	Canada
357	EUCTR2017-001240-35-DK (EUCTR)	25/06/2018	10/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
358	EUCTR2017-003359-43-HU (EUCTR)	21/06/2018	25/04/2018	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand
359	EUCTR2017-004209-41-ES (EUCTR)	21/06/2018	21/05/2018	A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic	A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar	Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira ® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 3	Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
360	EUCTR2017-002195-13-CZ (EUCTR)	19/06/2018	20/04/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
361	EUCTR2017-004295-55-HR (EUCTR)	19/06/2018	07/12/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
362	EUCTR2017-004292-31-HR (EUCTR)	18/06/2018	07/12/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
363	EUCTR2017-002195-13-SK (EUCTR)	18/06/2018	26/04/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
364	EUCTR2017-004294-14-HR (EUCTR)	18/06/2018	07/12/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	535	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
365	EUCTR2017-000575-88-LT (EUCTR)	15/06/2018	20/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305	Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1032	Phase 3	United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
366	EUCTR2017-000617-23-LT (EUCTR)	15/06/2018	20/04/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	983	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
367	EUCTR2017-002195-13-BE (EUCTR)	15/06/2018	30/03/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
368	EUCTR2017-001240-35-EE (EUCTR)	14/06/2018	07/05/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
369	EUCTR2017-001226-18-EE (EUCTR)	14/06/2018	07/05/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
370	NCT04329481 (ClinicalTrials.gov)	June 12, 2018	29/3/2020	The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients	The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients	Ulcerative Colitis;Crohn Disease;Inflammatory Bowel Diseases	Dietary Supplement: Mycodigest supplement	Tel-Aviv Sourasky Medical Center	NULL	Recruiting	18 Years	70 Years	All	100	N/A	Israel
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
371	NCT03566823 (ClinicalTrials.gov)	June 11, 2018	9/5/2018	Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)	Crohn's Disease	Biological: Ontamalimab;Other: Placebo	Shire	NULL	Terminated	16 Years	80 Years	All	34	Phase 3	United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Turkey;Ukraine
372	NCT03142321 (ClinicalTrials.gov)	June 8, 2018	3/5/2017	Defining Predictors of RT Response to Vedolizumab in IBD	Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers	Crohn Disease of Small Intestine	Drug: Vedolizumab 300 MG Injection [Entyvio]	Washington University School of Medicine	NULL	Recruiting	18 Years	N/A	All	80	Phase 4	United States
373	EUCTR2017-004293-33-BG (EUCTR)	06/06/2018	20/02/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
374	EUCTR2017-004292-31-BG (EUCTR)	06/06/2018	20/02/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
375	EUCTR2017-004294-14-BG (EUCTR)	06/06/2018	20/02/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	485	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
376	EUCTR2017-001226-18-LT (EUCTR)	06/06/2018	23/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
377	EUCTR2017-001225-41-LT (EUCTR)	06/06/2018	23/03/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
378	EUCTR2017-004295-55-BG (EUCTR)	06/06/2018	20/02/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
379	NCT03477032 (ClinicalTrials.gov)	June 1, 2018	19/3/2018	FMT in Inflammatory Bowel Disease	Faecal Transplantation in Inflammatory Bowel Disease	Faecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic Colitis	Biological: Faecal Microbiota Transplantation	St Vincent's Hospital Melbourne	NULL	Recruiting	18 Years	65 Years	All	50		Australia
380	NCT03559660 (ClinicalTrials.gov)	May 30, 2018	5/6/2018	CUP 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 Disease	Drug: Certolizumab Pegol	UCB Biopharma S.P.R.L.	NULL	Available	18 Years	N/A	All			NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
381	EUCTR2017-003359-43-BE (EUCTR)	28/05/2018	06/03/2019	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
382	EUCTR2017-001226-18-DK (EUCTR)	28/05/2018	16/02/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
383	EUCTR2017-002195-13-AT (EUCTR)	28/05/2018	18/04/2018	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease	A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI	Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 2;Phase 3	Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
384	EUCTR2014-002311-41-NL (EUCTR)	25/05/2018	18/12/2017	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE	Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 4	France;Belgium;Germany;Netherlands;United Kingdom;Sweden
385	EUCTR2017-002258-36-NL (EUCTR)	25/05/2018	17/10/2017	Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrence	A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER)	Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin -EIR INN or Proposed INN: RIFAXIMIN Other descriptive name: RIFAXIMINA	ALFASIGMA S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Spain;Belgium;Germany;Netherlands;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
386	EUCTR2017-003359-43-LT (EUCTR)	24/05/2018	17/04/2018	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 2	Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
387	EUCTR2016-003153-15-BE (EUCTR)	24/05/2018	07/02/2018	This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease	Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Czechia;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
388	EUCTR2017-004295-55-ES (EUCTR)	23/05/2018	01/03/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	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;Mexico;Canada;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic
389	EUCTR2017-003359-43-PL (EUCTR)	23/05/2018	24/04/2018	A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease	A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease	Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	255	Phase 2	United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
390	EUCTR2017-004293-33-SE (EUCTR)	23/05/2018	08/03/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	EUCTR2017-004292-31-LV (EUCTR)	21/05/2018	31/01/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Belarus;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
392	EUCTR2017-004294-14-LV (EUCTR)	21/05/2018	31/01/2018	Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	485	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
393	EUCTR2017-001226-18-LV (EUCTR)	21/05/2018	07/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	855	Phase 3	Ukraine;Chile;Israel;Russian Federation;Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Colombia;Switzerland;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
394	EUCTR2017-004295-55-LV (EUCTR)	21/05/2018	31/01/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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
395	EUCTR2017-001240-35-HU (EUCTR)	18/05/2018	07/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
396	EUCTR2017-001225-41-NL (EUCTR)	18/05/2018	08/03/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	738	Phase 3	Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
397	EUCTR2017-004295-55-GB (EUCTR)	18/05/2018	27/06/2018	Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease	A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
398	EUCTR2017-001225-41-HU (EUCTR)	18/05/2018	07/03/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	747	Phase 3	Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
399	EUCTR2017-001226-18-HU (EUCTR)	18/05/2018	07/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
400	EUCTR2017-001240-35-NL (EUCTR)	18/05/2018	08/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
401	EUCTR2017-003649-10-GB (EUCTR)	15/05/2018	11/12/2017	A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease	A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE	Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 1	Spain;Poland;Belgium;Germany;United Kingdom
402	EUCTR2017-001225-41-PT (EUCTR)	14/05/2018	19/02/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	738	Phase 3	Canada;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Brazil;United Kingdom;Egypt
403	EUCTR2017-001226-18-PT (EUCTR)	14/05/2018	01/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	United States;Portugal;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
404	EUCTR2017-001240-35-PT (EUCTR)	14/05/2018	01/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	United States;Portugal;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
405	EUCTR2017-002231-41-NL (EUCTR)	14/05/2018	26/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
406	EUCTR2016-003123-32-HR (EUCTR)	14/05/2018	29/05/2018	A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	855	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
407	EUCTR2016-003191-50-HR (EUCTR)	14/05/2018	29/05/2018	A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1250	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan
408	EUCTR2017-001225-41-ES (EUCTR)	10/05/2018	10/05/2018	A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	738	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
409	EUCTR2017-001240-35-PL (EUCTR)	10/05/2018	09/03/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	501	Phase 3	Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
410	EUCTR2017-004292-31-ES (EUCTR)	10/05/2018	23/02/2018	Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease	Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
411	EUCTR2017-001240-35-ES (EUCTR)	10/05/2018	10/05/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 3	Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
412	EUCTR2017-001226-18-PL (EUCTR)	10/05/2018	12/03/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	645	Phase 3	Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
413	EUCTR2017-001226-18-ES (EUCTR)	09/05/2018	10/05/2018	A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy	Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	855	Phase 3	Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden
414	EUCTR2016-003179-23-BE (EUCTR)	07/05/2018	16/02/2018	This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)	Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany
415	EUCTR2016-003123-32-LT (EUCTR)	07/05/2018	23/01/2018	A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease	Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	855	Phase 3	Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
416	EUCTR2016-003191-50-LT (EUCTR)	07/05/2018	01/02/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1250	Phase 3	Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
417	EUCTR2016-003190-17-HR (EUCTR)	04/05/2018	16/05/2019	A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment	Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	579	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04151225
(ClinicalTrials.gov)

April 5, 2021

4/11/2019

Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease

A 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 Disease

Crohns Disease

Drug: GSK2330811;Drug: Placebo

GlaxoSmithKline

NULL

Withdrawn

18 Years

N/A

All

Phase 2

NULL

NCT03870334
(ClinicalTrials.gov)

March 2021

8/3/2019

Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: BT-11 1,000 mg;Drug: Placebo

Landos Biopharma Inc.

NULL

Not yet recruiting

18 Years

75 Years

All

130

Phase 2

NULL

NCT04118088
(ClinicalTrials.gov)

January 15, 2021

4/10/2019

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

Crohn's Disease;Complex Perianal Fistula

Biological: Darvadstrocel

Millennium Pharmaceuticals, Inc.

NULL

Recruiting

18 Years

N/A

All

Phase 4

Austria;Czechia;France;Germany;Spain

ChiCTR2000036845

2021-01-01

2020-08-25

A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease

Crohn's disease

Proctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ;

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

NULL

Pending

Both

Proctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60;

Phase 4

China

NCT04643483
(ClinicalTrials.gov)

January 2021

19/11/2020

A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease

A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: Certolizumab pegol;Drug: Adalimumab;Drug: Placebo

UCB Biopharma SRL

NULL

Not yet recruiting

6 Years

17 Years

All

150

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03992469
(ClinicalTrials.gov)

January 2021

18/6/2019

Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's Disease

Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease

Crohn's Disease

Drug: BFAHF-2;Drug: Placebo

Icahn School of Medicine at Mount Sinai

NULL

Not yet recruiting

18 Years

30 Years

All

Phase 1

United States

NCT04629196
(ClinicalTrials.gov)

January 2021

10/11/2020

Induction Optimization With Stelara for Crohn's Disease

Crohn Disease

Drug: Ustekinumab

NYU Langone Health

NULL

Not yet recruiting

18 Years

70 Years

All

113

Phase 4

United States

NCT04655807
(ClinicalTrials.gov)

December 16, 2020

30/11/2020

A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's Disease

Crohn Disease

Drug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: Ustekinumab

Janssen Research & Development, LLC

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 2

United States;France;Germany;Italy;Spain;Sweden

NCT03414788
(ClinicalTrials.gov)

December 7, 2020

8/1/2018

Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease

PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS

Inflammatory Bowel Disease

Biological: PF 06687234;Biological: [124I]IB PF 06687234

Pfizer

NULL

Withdrawn

18 Years

75 Years

All

Phase 1

United States

EUCTR2020-002674-26-GB
(EUCTR)

02/12/2020

26/11/2020

A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.

A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy.

Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

508

Phase 3

United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03747718
(ClinicalTrials.gov)

December 1, 2020

8/3/2018

Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children

A Study for Evaluation of Clinical Response to Single vs. Maintenance Fecal Microbiota Transplantation in Pediatric Patients With Refractory Crohn's Disease

Crohn Disease

Biological: Fecal Microbiota Transplantation;Other: Placebo

Stanford University

NULL

Not yet recruiting

2 Years

25 Years

All

Phase 1

United States

NCT04660136
(ClinicalTrials.gov)

December 1, 2020

2/12/2020

Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients

Crohn's Disease in Pediatric Patient

Biological: contrast enhanced ultrasound

Yonsei University

NULL

Recruiting

2 Years

18 Years

All

Phase 4

Korea, Republic of

NCT04263831
(ClinicalTrials.gov)

December 1, 2020

7/2/2020

LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE

Crohn Disease

Drug: Interleukin-2 (aldesleukin).

Boston Children's Hospital

NULL

Not yet recruiting

18 Years

80 Years

All

Phase 1;Phase 2

United States

NCT04530877
(ClinicalTrials.gov)

December 1, 2020

24/8/2020

Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease

Crohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal Healing

Biological: Infliximab;Dietary Supplement: Exclusive Enteral Nutrition

Children's Hospital of Fudan University

NULL

Not yet recruiting

1 Year

18 Years

All

Phase 4

NULL

NCT04073472
(ClinicalTrials.gov)

December 1, 2020

23/8/2019

Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's

A 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 Pouch

Crohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, Ileoanal

Drug: mesenchymal stem cells (MSCs)

The Cleveland Clinic

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04456517
(ClinicalTrials.gov)

December 2020

29/6/2020

Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea

Crohn's Disease;Inflammatory Bowel Disease

Drug: Ranolazine;Drug: Placebo

Vanderbilt University Medical Center

NULL

Not yet recruiting

18 Years

N/A

All

Phase 2

United States

EUCTR2020-002674-26-AT
(EUCTR)

23/11/2020

18/11/2020

A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

508

Phase 3

NCT04519671
(ClinicalTrials.gov)

November 19, 2020

17/8/2020

Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease

A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease

Perianal Crohn Disease;Perianal Fistula;Crohn Disease

Drug: Mesenchymal Stem Cells;Other: Placebo

The Cleveland Clinic

NULL

Recruiting

18 Years

75 Years

All

Phase 1;Phase 2

United States

EUCTR2017-003090-34-DK
(EUCTR)

12/11/2020

15/06/2020

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD

Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Austria;Denmark;Netherlands;Germany

NCT04112212
(ClinicalTrials.gov)

November 4, 2020

25/9/2019

NIR 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, Ulcerative

Drug: Vedolizumab -800CW;Device: Fluorescence endoscopy and spectroscopy

University Medical Center Groningen

NULL

Recruiting

18 Years

N/A

All

Phase 1

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-002674-26-NL
(EUCTR)

29/10/2020

15/09/2020

A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

508

Phase 3

United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

NCT04519684
(ClinicalTrials.gov)

October 28, 2020

17/8/2020

Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's Disease

A Phase IB/IIA Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch

Ileal Pouch;Crohn Disease

Drug: Mesenchymal stem cells;Other: Placebo

The Cleveland Clinic

NULL

Recruiting

18 Years

75 Years

All

Phase 1;Phase 2

United States

NCT04519697
(ClinicalTrials.gov)

October 28, 2020

17/8/2020

Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease

A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.

Rectovaginal Fistula;Crohn Disease;Crohn Disease of Vulva;Rectolabial; Fistula

Drug: Mesenchymal Stem Cells;Other: Placebo

The Cleveland Clinic

NULL

Recruiting

18 Years

75 Years

Female

Phase 1;Phase 2

United States

ChiCTR2000035737

2020-10-01

2020-08-16

Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial

Crohn's disease

Experimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience;

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

NULL

Pending

Both

Experimental group:45;Control group:45;

China

NCT04535882
(ClinicalTrials.gov)

October 1, 2020

28/8/2020

Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease Colitis

LRG Levels

Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels

Showa Inan General Hospital

NULL

Recruiting

N/A

All

100

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04308850
(ClinicalTrials.gov)

October 2020

24/2/2020

Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency

Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency,a Prospective Cohort Study

Crohn's Disease;Vitamin D Deficiency;Vitamin D Supplement

Drug: Vitamin D drops

Second Affiliated Hospital of Wenzhou Medical University

NULL

Not yet recruiting

N/A

All

Early Phase 1

China

NCT04276636
(ClinicalTrials.gov)

October 2020

17/2/2020

Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency

Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort Study

Crohn's Disease;Vitamin D Deficiency;Vitamin D Supplement

Drug: Caltrate Pill

Second Affiliated Hospital of Wenzhou Medical University

NULL

Not yet recruiting

N/A

All

Early Phase 1

China

NCT04276649
(ClinicalTrials.gov)

October 2020

17/2/2020

Exploring the Effects of Caltrate Supplement on the Chronic Course of Ulcerative Colitis Patients With Vitamin D Deficiency

Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort Study

Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement

Drug: Caltrate Pill

Second Affiliated Hospital of Wenzhou Medical University

NULL

Not yet recruiting

N/A

All

Early Phase 1

China

EUCTR2020-001811-26-NL
(EUCTR)

30/09/2020

08/07/2020

IBD under control with less medication

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study

Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB

University Medical Center Groningen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Netherlands

NCT04524611
(ClinicalTrials.gov)

September 30, 2020

20/8/2020

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

Crohn's Disease (CD)

Drug: Risankizumab;Drug: Ustekinumab

AbbVie

NULL

Recruiting

18 Years

80 Years

All

517

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04223518
(ClinicalTrials.gov)

September 20, 2020

6/1/2020

Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)

Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease

Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease

Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo

Monisha Hitesh Shah

NULL

Recruiting

6 Years

30 Years

All

Early Phase 1

United States

EUCTR2018-004614-18-DK
(EUCTR)

08/09/2020

05/08/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1

moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan

ChiCTR2000037094

2020-09-01

2020-08-26

Discovery and detection of a novel antigen for Crohn’s disease (CD)

Inflammatory Bowel Disease

Gold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA;

The First Affiliated Hospital of Anhui Medical University

NULL

Completed

Both

Target condition:100;Difficult condition:100

China

NCT04331639
(ClinicalTrials.gov)

September 2020

23/3/2020

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency

Dietary Supplement: vitamin D3

Boston Children's Hospital

NULL

Not yet recruiting

5 Years

25 Years

All

Phase 2

NULL

NCT04398836
(ClinicalTrials.gov)

September 2020

18/7/2019

Preoperative Nutrition for Crohn's Disease Patients

Malnutrition;Crohn Disease

Dietary Supplement: Exclusive Enteral Nutrition;Other: High energy / protein diet.;Other: Standard nutrition

Tel-Aviv Sourasky Medical Center

NULL

Not yet recruiting

18 Years

70 Years

All

144

Phase 3

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04502303
(ClinicalTrials.gov)

September 2020

4/8/2020

18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease

A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT

Crohn Disease

Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT

Peking Union Medical College Hospital

NULL

Not yet recruiting

18 Years

N/A

All

Phase 2

NULL

EUCTR2018-004614-18-HR
(EUCTR)

24/08/2020

23/11/2020

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden

EUCTR2017-002491-10-AT
(EUCTR)

19/08/2020

11/05/2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czech Republic;Spain;Austria;Germany;United Kingdom

EUCTR2019-002895-14-GB
(EUCTR)

05/08/2020

02/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Slovenia;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China

EUCTR2019-002895-14-NL
(EUCTR)

05/08/2020

23/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03943446
(ClinicalTrials.gov)

August 4, 2020

7/5/2019

TAK-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 Recurrence

Crohn Disease

Drug: TAK-018;Drug: TAK-018 Placebo

Millennium Pharmaceuticals, Inc.

NULL

Recruiting

18 Years

N/A

All

Phase 2

United States;Austria;France;Germany;United Kingdom;Netherlands

NCT04362735
(ClinicalTrials.gov)

August 1, 2020

19/4/2020

Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy

Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world Study

Crohn Disease

Drug: Vedolizumab

Pontifícia Universidade Católica do Paraná

Takeda

Not yet recruiting

18 Years

N/A

All

100

NULL

EUCTR2019-002895-14-PT
(EUCTR)

27/07/2020

06/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan

EUCTR2017-002491-10-FR
(EUCTR)

17/07/2020

09/03/2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czech Republic;Spain;Austria;Germany;United Kingdom

NCT04312659
(ClinicalTrials.gov)

July 15, 2020

3/3/2020

A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

Crohn Disease

Drug: Infliximab

Johnson & Johnson (China) Investment Ltd.

NULL

Recruiting

6 Years

17 Years

All

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-001673-93-HU
(EUCTR)

07/07/2020

09/06/2020

A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.

An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials

Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of

NCT03935451
(ClinicalTrials.gov)

July 1, 2020

23/4/2019

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study

IBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal Disorders

Drug: Apixaban 2.5 milligram;Drug: Placebo Oral Tablet

McMaster University

NULL

Not yet recruiting

18 Years

N/A

All

Early Phase 1

NULL

EUCTR2019-003335-37-DE
(EUCTR)

29/06/2020

27/11/2019

A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease.

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET

Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: JNJ-67864238
Product Code: JNJ-67864238
INN or Proposed INN: Not available
Other descriptive name: PTG-200

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Argentina;Poland;Russian Federation;Germany;Italy

EUCTR2017-002491-10-DE
(EUCTR)

22/06/2020

09/03/2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom

EUCTR2017-001240-35-FR
(EUCTR)

22/06/2020

09/03/2020

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies

Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04232553
(ClinicalTrials.gov)

June 22, 2020

15/1/2020

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

Crohn's Disease

Drug: Mirikizumab

Eli Lilly and Company

NULL

Recruiting

18 Years

N/A

All

778

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Romania;Russian Federation;Spain;Turkey;Ukraine

NCT04163016
(ClinicalTrials.gov)

June 19, 2020

24/10/2019

A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis

Drug: Pharmacokinetics of certolizumab pegol

UCB Biopharma S.P.R.L.

NULL

Recruiting

18 Years

N/A

Female

Phase 1

United States;Canada;Switzerland

EUCTR2018-004346-42-AT
(EUCTR)

18/06/2020

21/01/2020

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 , AGN-151-598
Trade Name: Humira ®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany

NCT04397263
(ClinicalTrials.gov)

June 10, 2020

18/5/2020

A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Crohns Disease

Drug: Guselkumab

Janssen Pharmaceutical K.K.

NULL

Recruiting

18 Years

N/A

All

Phase 3

Japan

JPRN-JapicCTI-205298

10/6/2020

26/05/2020

A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Intervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Janssen Pharmaceutical K.K.

NULL

pending

BOTH

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002687-27-NL
(EUCTR)

28/05/2020

18/05/2020

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2

Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

778

Phase 3

United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan

EUCTR2018-004346-42-BG
(EUCTR)

28/05/2020

08/01/2020

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany

EUCTR2019-002895-14-BG
(EUCTR)

21/05/2020

23/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan

EUCTR2018-004614-18-LT
(EUCTR)

20/05/2020

25/11/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan

EUCTR2019-001673-93-DE
(EUCTR)

19/05/2020

02/03/2020

A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.

An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolilmab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04362254
(ClinicalTrials.gov)

May 15, 2020

23/4/2020

A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Fistulising Crohn's Disease Who Have Completed Previous Spesolimab Trials

Crohn Disease

Drug: Spesolimab

Boehringer Ingelheim

NULL

Recruiting

18 Years

N/A

All

Phase 2

Austria;Germany

EUCTR2019-002895-14-ES
(EUCTR)

14/05/2020

15/05/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 2

NCT04372108
(ClinicalTrials.gov)

May 14, 2020

30/4/2020

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease

An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database

Crohn Disease

Drug: Ustekinumab;Drug: Other Biologic Therapies

Janssen Scientific Affairs, LLC

NULL

Recruiting

18 Years

N/A

All

1536

United States

EUCTR2019-000176-41-HU
(EUCTR)

07/05/2020

16/03/2020

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment

Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy

EUCTR2019-000886-19-AT
(EUCTR)

06/05/2020

06/09/2019

A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018

Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Austria;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000333-39-BE
(EUCTR)

04/05/2020

21/01/2020

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula

A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

EUCTR2019-002895-14-NO
(EUCTR)

04/05/2020

20/12/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;Belarus;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan

ChiCTR2000031344

2020-05-01

2020-03-28

Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study

Crohn's disease

Group 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection;

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

NULL

Pending

Both

Group 1:35;Group 2:35;

China

EUCTR2019-002687-27-HU
(EUCTR)

28/04/2020

09/03/2020

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2

Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

778

Phase 3

EUCTR2019-004219-29-NL
(EUCTR)

21/04/2020

04/02/2020

Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s Disease

Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ

Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Azithromycin
Product Name: Azithromycin
INN or Proposed INN: Azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: METRONIDAZOLE

Amsterdam UMC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Israel;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03905109
(ClinicalTrials.gov)

April 15, 2020

3/4/2019

Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease

A 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 Treatment

Crohn Disease

Drug: ABX464;Drug: Placebo

Abivax S.A.

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 2

Belgium

EUCTR2018-004346-42-BE
(EUCTR)

15/04/2020

03/03/2020

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Allergan Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany

NCT04225819
(ClinicalTrials.gov)

April 1, 2020

3/1/2020

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial

IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency

Dietary Supplement: Vitamin D3;Other: Placebo

Massachusetts General Hospital

NULL

Not yet recruiting

18 Years

N/A

All

100

N/A

NULL

EUCTR2018-004346-42-HU
(EUCTR)

25/03/2020

31/01/2020

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany

EUCTR2018-004346-42-CZ
(EUCTR)

24/03/2020

22/01/2020

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-001337-13-FR
(EUCTR)

18/03/2020

02/03/2020

USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study

USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP

patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: STELARA
Trade Name: STELARA 90 mg solution for injection in pre-filled syringe

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

146

Phase 4

France

EUCTR2018-002629-51-GB
(EUCTR)

16/03/2020

08/01/2020

A 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 Tract

A 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)

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

France;United States;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2017-002491-10-CZ
(EUCTR)

10/03/2020

27/11/2019

Postauthorization Safety Study of Darvadstrocel Repeat Administration

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Czech Republic;Spain;Austria;Germany;United Kingdom

NCT03492944
(ClinicalTrials.gov)

March 6, 2020

12/2/2018

Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography

Crohn Disease

Drug: Ultrasound Microbubble Contrast Agent;Device: Ultrasound Imaging

Children's Hospital Medical Center, Cincinnati

NULL

Recruiting

10 Years

18 Years

All

United States

EUCTR2019-000886-19-NL
(EUCTR)

06/03/2020

17/09/2019

A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection

Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018

Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Austria;Germany;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-001976-48-FR
(EUCTR)

06/03/2020

09/07/2018

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 2

United States;Portugal;Taiwan;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;China;Japan;Korea, Republic of

NCT04188990
(ClinicalTrials.gov)

March 5, 2020

2/12/2019

Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition

Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition

Pancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal Cancer

Dietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current care

Hospital Galdakao-Usansolo

NULL

Not yet recruiting

18 Years

N/A

All

900

N/A

NULL

ChiCTR2000029323

2020-03-01

2020-01-25

Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial

Crohn's disease

Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab;

Renji Hospital, School of Medicine, Shanghai Jiaotong University

NULL

Pending

Both

Experimental group:30;Control group:30;

China

NCT04014517
(ClinicalTrials.gov)

March 1, 2020

8/7/2019

Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients

Crohn Disease

Other: Standard of Care;Dietary Supplement: Immunonutrition

Istituto Clinico Humanitas

NULL

Not yet recruiting

18 Years

N/A

All

350

N/A

NULL

EUCTR2019-002895-14-SK
(EUCTR)

26/02/2020

10/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004614-18-LV
(EUCTR)

19/02/2020

12/12/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

EUCTR2019-002895-14-FR
(EUCTR)

17/02/2020

08/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States

NCT04254783
(ClinicalTrials.gov)

February 16, 2020

3/2/2020

A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Ulcerative Colitis (UC);Crohn's Disease

Drug: Risankizumab;Drug: Cytochrome P450 (CYP) Substrates

AbbVie

NULL

Recruiting

18 Years

80 Years

All

Phase 1

United States;Germany;Israel

EUCTR2019-002895-14-LT
(EUCTR)

13/02/2020

19/12/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan

NCT04173273
(ClinicalTrials.gov)

February 12, 2020

20/11/2019

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: Etrasimod;Drug: Placebo

Arena Pharmaceuticals

NULL

Recruiting

18 Years

80 Years

All

1265

Phase 2;Phase 3

United States;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000176-41-IT
(EUCTR)

11/02/2020

05/11/2020

Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071

Otsuka Pharmaceutical Development and Commercialization, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Hungary;Canada;Poland;Belgium;Germany;Italy

ChiCTR2000029543

2020-02-08

2020-02-03

A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease

Crohn's Disease

Gold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines;

The First Hospital Affiliated to Sun Yat sen University

NULL

Recruiting

Both

Target condition:350;Difficult condition:0

China

NCT03999580
(ClinicalTrials.gov)

February 7, 2020

24/6/2019

The 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 Children

Crohn Disease

Drug: vitamin D3

Jantchou Prevost

NULL

Recruiting

4 Years

18 Years

All

316

Phase 3

Canada

EUCTR2019-001673-93-AT
(EUCTR)

05/02/2020

13/12/2019

A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.

An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of

NCT03950336
(ClinicalTrials.gov)

February 4, 2020

13/5/2019

Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease Patients

Influence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's Patients

Healthy First Degree Relatives of Crohn's Disease Patients

Dietary Supplement: Prebiotics;Other: Low n-6 PUFA Diet;Dietary Supplement: Maltodextrin;Other: Control Diet

University of Alberta

NULL

Recruiting

15 Years

50 Years

All

N/A

Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002895-14-HU
(EUCTR)

03/02/2020

04/02/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Switzerland;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan

NCT03961815
(ClinicalTrials.gov)

February 3, 2020

8/5/2019

Open-label Extension Study of Brazikumab in Crohn's Disease

An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: Brazikumab

Allergan

NULL

Enrolling by invitation

16 Years

80 Years

All

1000

Phase 3

United States

EUCTR2019-000852-32-NL
(EUCTR)

30/01/2020

08/10/2019

A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.

A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study

Inflammatory Bowel Disease, Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Naltrexone hydrochloride

ErasmusMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

122

Phase 2

Netherlands

EUCTR2019-000886-19-FR
(EUCTR)

20/01/2020

26/07/2019

A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Millennium Pharmaceuticals, Inc (a wholly owned subsidiary

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Germany;United Kingdom

100

EUCTR2019-000176-41-PL
(EUCTR)

17/01/2020

06/09/2019

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Canada;Belgium;Poland;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2019-002895-14-GR
(EUCTR)

14/01/2020

03/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan

102

EUCTR2019-002895-14-CZ
(EUCTR)

09/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease

Arena Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan

103

NCT04224558
(ClinicalTrials.gov)

January 1, 2020

4/4/2018

Stem Cell Transplantation in Crohn's Disease

Autologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease

Crohn Disease

Drug: Mesna;Drug: Cyclophosphamide;Drug: Filgrastim;Procedure: Apheresis catheter placement;Procedure: Leukapheresis;Drug: Fludarabine;Drug: Methylprednisolone;Drug: Diphenhydramine;Drug: Acetaminophen;Drug: anti-thymocyte globulin (rabbit);Drug: lymphocyte immune globulin;Biological: Peripheral Blood Stem Cell Infusion;Drug: Cytoxan

Cedars-Sinai Medical Center

NULL

Not yet recruiting

16 Years

24 Years

All

Phase 1;Phase 2

United States

104

NCT04239248
(ClinicalTrials.gov)

January 2020

27/11/2019

Tasty&Healthy Dietary Approach for Crohn's Disease

Tasty&Healthy is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's Disease

Crohn Disease

Dietary Supplement: Tasty&Healthy intervention group;Dietary Supplement: EEN intervention group

Shaare Zedek Medical Center

NULL

Not yet recruiting

6 Years

24 Years

All

192

N/A

Israel

105

NCT04233463
(ClinicalTrials.gov)

January 2020

15/1/2020

The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized Study

Crohn Disease

Dietary Supplement: Modulen;Drug: Budesonide

Hillel Yaffe Medical Center

NULL

Not yet recruiting

18 Years

70 Years

All

N/A

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2018-004346-42-ES
(EUCTR)

26/12/2019

11/11/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden

107

EUCTR2019-003662-40-DE
(EUCTR)

18/12/2019

22/10/2019

Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)

MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen
INN or Proposed INN: ADALIMUMAB

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Germany

108

EUCTR2017-001976-48-PT
(EUCTR)

16/12/2019

22/05/2019

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 2

Portugal;United States;Taiwan;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;Japan;China;Korea, Republic of

109

EUCTR2018-005086-39-HR
(EUCTR)

16/12/2019

17/01/2020

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina

110

EUCTR2019-003816-29-FR
(EUCTR)

16/12/2019

14/10/2019

Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal

Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal - MIRACLE

Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2018-004346-42-DE
(EUCTR)

10/12/2019

17/06/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany

112

EUCTR2017-004294-14-FR
(EUCTR)

02/12/2019

09/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;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

113

NCT03915262
(ClinicalTrials.gov)

December 2, 2019

9/4/2019

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy

Crohn Disease

Biological: Search for exocrine pancreatic insufficiency at week 0 and 12

Hospices Civils de Lyon

NULL

Recruiting

18 Years

N/A

All

France

114

NCT04134065
(ClinicalTrials.gov)

December 1, 2019

17/10/2019

the Effect of Vitamin D in Crohn's Disease

the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease

Vitamin D Deficiency;Crohn Disease

Drug: Vitamin D;Drug: Placebo oral capsule

Nanjing University School of Medicine

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Not yet recruiting

20 Years

60 Years

All

Early Phase 1

NULL

115

NCT02677350
(ClinicalTrials.gov)

December 1, 2019

1/2/2016

AlloGeneic 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 Cells

Drug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)

Joshua M Hare

NULL

Withdrawn

18 Years

N/A

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

EUCTR2019-001087-30-AT
(EUCTR)

28/11/2019

12/09/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan

117

EUCTR2017-001240-35-SI
(EUCTR)

27/11/2019

12/11/2019

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

118

EUCTR2019-000886-19-DE
(EUCTR)

26/11/2019

29/07/2019

A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection

Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018

Millennium Pharmaceuticals, Inc (A wholly owned subsidiary of Takeda Pharmaceutical Company Limited)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Austria;Netherlands;Germany;United Kingdom

119

EUCTR2018-001895-39-HR
(EUCTR)

21/11/2019

20/01/2020

A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2

Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

258

Phase 2

Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands

120

EUCTR2019-003068-39-NL
(EUCTR)

20/11/2019

04/11/2019

In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.

Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study

Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

UMC Utrecht

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

EUCTR2017-004293-33-FR
(EUCTR)

12/11/2019

09/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Serbia;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

122

EUCTR2018-002629-51-AT
(EUCTR)

12/11/2019

27/06/2019

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

France;United States;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden

123

ChiCTR1900027370

2019-11-11

2019-11-10

The pathogenic genes and flora of Crohn's disease with anal fistula

Crohn's disease with anal fistula

CD anal fistula and CD without anal fistula:N/A;

Nanfang Hospital, Southern Medical University

NULL

Recruiting

Both

CD anal fistula and CD without anal fistula:50;

N/A

China

124

EUCTR2019-001087-30-HR
(EUCTR)

11/11/2019

17/01/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Japan

125

EUCTR2019-000886-19-GB
(EUCTR)

06/11/2019

29/07/2019

A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection

Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018

Millennium Pharmaceuticals, Inc (a wholly owned subsidiary

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Austria;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2017-004292-31-FR
(EUCTR)

05/11/2019

09/08/2019

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Belarus;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

127

EUCTR2018-004346-42-FR
(EUCTR)

05/11/2019

10/07/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

128

NCT04075825
(ClinicalTrials.gov)

November 4, 2019

22/8/2019

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study

Crohn's Disease;Complex Perianal Fistula

Biological: Darvadstrocel

Millennium Pharmaceuticals, Inc.

NULL

Recruiting

18 Years

N/A

All

150

Phase 3

United States;Belgium;Czechia;France;Hungary;Israel;Italy;Poland;Spain

129

NCT04154735
(ClinicalTrials.gov)

November 2019

8/3/2019

Autologous Transplant Targeted Against Crohn's

Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease

Crohn's Disease

Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: Tacrolimus

Northwestern University

NULL

Withdrawn

18 Years

49 Years

All

Phase 2

United States

130

EUCTR2019-001087-30-DE
(EUCTR)

31/10/2019

01/07/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2019-001087-30-BG
(EUCTR)

30/10/2019

24/10/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

132

NCT03945019
(ClinicalTrials.gov)

October 28, 2019

8/5/2019

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Biological: CT-P13 SC (Infliximab);Other: Placebo SC

Celltrion

NULL

Recruiting

18 Years

75 Years

All

600

Phase 3

United States

133

EUCTR2018-005086-39-HU
(EUCTR)

28/10/2019

08/04/2019

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina

134

NCT03962998
(ClinicalTrials.gov)

October 27, 2019

22/5/2019

Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability

A 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 Disease

Crohn Disease

Drug: Lactulose /Rhamnose solution;Drug: MB-102

MediBeacon

NULL

Recruiting

18 Years

N/A

All

Early Phase 1

United States

135

EUCTR2019-002093-32-SE
(EUCTR)

24/10/2019

28/06/2019

A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.

Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease.

None. Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial. Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated.
MedDRA version: 20.1;Level: LLT;Classification code 10011603;Term: CT scan;System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Lument AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

EUCTR2018-004614-18-NL
(EUCTR)

21/10/2019

27/06/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

137

EUCTR2018-004614-18-DE
(EUCTR)

15/10/2019

25/06/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

138

EUCTR2019-000333-39-CZ
(EUCTR)

15/10/2019

03/09/2019

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

139

EUCTR2017-004295-55-FR
(EUCTR)

08/10/2019

09/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

140

EUCTR2018-005086-39-PL
(EUCTR)

07/10/2019

06/05/2019

A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

NCT04131322
(ClinicalTrials.gov)

October 2019

10/10/2019

Loss 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 Study

Crohn Disease;Ulcerative Colitis

Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

NULL

Not yet recruiting

18 Years

N/A

All

216

Phase 4

NULL

142

EUCTR2018-001895-39-NL
(EUCTR)

27/09/2019

03/06/2019

A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

258

Phase 2

Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany

143

NCT04102111
(ClinicalTrials.gov)

September 23, 2019

23/9/2019

A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: JNJ-67864238;Drug: Placebo

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

75 Years

All

Phase 2

United States;Argentina;France;Germany;Italy;Poland;Russian Federation;Ukraine

144

ChiCTR1900026091

2019-09-19

2019-09-20

Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease

Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study

Crohn's disease

Case series:infliximab;

The First Affiliated Hospital of Sun Yat-sen University

NULL

Pending

Both

Case series:343;

China

145

EUCTR2018-004614-18-GB
(EUCTR)

16/09/2019

20/06/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2018-004614-18-ES
(EUCTR)

12/09/2019

04/07/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Lilly S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

147

EUCTR2018-004614-18-FR
(EUCTR)

11/09/2019

20/06/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

148

EUCTR2018-004346-42-GB
(EUCTR)

10/09/2019

30/05/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden

149

NCT03885713
(ClinicalTrials.gov)

September 10, 2019

4/3/2019

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

180

Phase 4

Spain

150

EUCTR2017-004588-11-NL
(EUCTR)

10/09/2019

Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.

Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial

The Chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Maastricht University Medical Centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

146

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2019-001087-30-PL
(EUCTR)

09/09/2019

24/06/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

152

EUCTR2018-001895-39-BG
(EUCTR)

05/09/2019

16/07/2019

A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

258

Phase 2

Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands

153

EUCTR2019-001948-21-FR
(EUCTR)

03/09/2019

15/05/2019

Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas.

Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas. - ADICROHN-II

Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: autologous ADIpose derived stromal vascular fraction
Product Code: ADSVF
Trade Name: vialebex 200mg
Product Name: VIALEBEX
Product Code: SERUM ALBUMINE 5%
INN or Proposed INN: ALBUMINE HUMAINE
Other descriptive name: HUMAN ALBUMIN AS MACROAGGREGATES
Trade Name: serum physiologique 0.9 %
Product Name: chlorure de sodium
INN or Proposed INN: CHLORURE DE SODIUM
Other descriptive name: SODIUM CHLORIDE

ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France

154

EUCTR2018-004614-18-PL
(EUCTR)

03/09/2019

09/07/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden

155

EUCTR2019-001087-30-GR
(EUCTR)

28/08/2019

26/07/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

EUCTR2019-001087-30-ES
(EUCTR)

14/08/2019

10/09/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

157

EUCTR2019-001087-30-FR
(EUCTR)

13/08/2019

14/06/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

158

EUCTR2019-001087-30-HU
(EUCTR)

09/08/2019

10/08/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

159

EUCTR2019-001087-30-CZ
(EUCTR)

06/08/2019

06/06/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSINA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan

160

EUCTR2018-002629-51-FR
(EUCTR)

31/07/2019

24/04/2019

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

United States;France;Spain;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2019-001087-30-LV
(EUCTR)

25/07/2019

04/06/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

162

EUCTR2018-004614-18-HU
(EUCTR)

25/07/2019

11/06/2019

Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1100

Phase 3

Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

163

NCT03926130
(ClinicalTrials.gov)

July 23, 2019

23/4/2019

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: Mirikizumab;Drug: Ustekinumab;Drug: Placebo

Eli Lilly and Company

NULL

Recruiting

15 Years

80 Years

All

1150

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom

164

EUCTR2017-000725-12-DE
(EUCTR)

17/07/2019

28/02/2019

A 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.

Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

165

EUCTR2016-003191-50-FR
(EUCTR)

17/07/2019

28/01/2019

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

959

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

EUCTR2017-001226-18-SI
(EUCTR)

15/07/2019

06/03/2019

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden

167

NCT04056442
(ClinicalTrials.gov)

July 7, 2019

13/8/2019

A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients

Steroid Dependent Crohn's Disease

Drug: Cannabidiol , synthetic form;Drug: Placebo

Stero Biotechs Ltd.

NULL

Recruiting

18 Years

N/A

All

Phase 2

Israel

168

ChiCTR1900023696

2019-07-01

2019-06-08

Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial

Chron's disease

Group 1:EBD;Group 2:EBD combined with local injection of betamethasone;

The Sixth Affiliated Hospital of Sun Yat-sen University

NULL

Pending

Both

Group 1:45;Group 2:45;

N/A

China

169

NCT03914261
(ClinicalTrials.gov)

July 1, 2019

11/4/2019

Expanded Access to Risankizumab

Crohn's Disease;Ulcerative Colitis (UC)

Drug: Risankizumab

AbbVie

NULL

Available

18 Years

N/A

All

Belgium;Israel;Spain;Switzerland;United States

170

JPRN-JapicCTI-194830

01/7/2019

27/06/2019

Specified 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 disease

Intervention 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 Limited

NULL

pending

BOTH

300

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

NCT04002180
(ClinicalTrials.gov)

July 1, 2019

26/6/2019

Specified 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 Disease

Drug: Vedolizumab (Genetical Recombination)

Takeda

NULL

Recruiting

N/A

All

300

Japan

172

NCT04089514
(ClinicalTrials.gov)

June 30, 2019

12/9/2019

A Real-world Study of Imraldi® Use

Pan-EU Real-World Experience With Imraldi®

Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC)

Drug: Adalimumab

Biogen

NULL

Recruiting

18 Years

N/A

All

1400

Germany;United Kingdom

173

EUCTR2019-002038-35-BE
(EUCTR)

27/06/2019

07/06/2019

A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients

A prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST

Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Stelara
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB

UZ Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Belgium

174

EUCTR2019-000717-37-ES
(EUCTR)

27/06/2019

28/06/2019

Loss of response of the Adalimumba biosimilar compared with the original drug

LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY. ADA-SWITCH Study - ADA-SWITCH Study

Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Phase 4

Spain

175

EUCTR2017-004997-32-DE
(EUCTR)

25/06/2019

14/12/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

NCT04254549
(ClinicalTrials.gov)

June 14, 2019

3/2/2020

Rifaximin in Patients With Diabetic Gastroparesis

Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.

Crohn Disease;Diabetic Gastroparesis

Drug: Rifaximin;Drug: Placebo

Mayo Clinic

NULL

Recruiting

18 Years

75 Years

All

Phase 2

United States

177

EUCTR2017-002195-13-GB
(EUCTR)

05/06/2019

28/02/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand

178

NCT03941418
(ClinicalTrials.gov)

June 1, 2019

5/5/2019

Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease

Ulcerative Colitis;Crohn Disease

Dietary Supplement: Boulardii;Dietary Supplement: Placebo

University Clinic Dr Dragisa Misovic-Dedinje

University Clinic Zvezdara

Not yet recruiting

18 Years

80 Years

All

150

N/A

NULL

179

NCT03677648
(ClinicalTrials.gov)

May 14, 2019

17/9/2018

A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: SHR0302;Drug: Placebos

Reistone Biopharma Company Limited

NULL

Recruiting

18 Years

75 Years

All

144

Phase 2

United States;China;Poland;Ukraine

180

EUCTR2017-003090-34-HU
(EUCTR)

10/05/2019

25/03/2019

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD

Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Austria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

EUCTR2016-003190-17-FR
(EUCTR)

07/05/2019

14/03/2019

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand

182

ChiCTR1900022728

2019-05-01

2019-04-23

Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease

Crohn's disease

Gold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD;

The 7th Medical Center of the PLA General Hospital (Army general hospital)

NULL

Pending

Both

Target condition:310;Difficult condition:160

China

183

EUCTR2018-004967-30-GB
(EUCTR)

30/04/2019

14/01/2019

Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over Study

IBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS

Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Imraldi
Product Name: Imraldi
INN or Proposed INN: adalimumab
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab

University Hospital Southampton NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United Kingdom

184

EUCTR2018-003594-95-NL
(EUCTR)

30/04/2019

Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy

Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response

Inflammatory bowel disease: Crohn's disease and Ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Amsterdam UMC location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

185

NCT03733314
(ClinicalTrials.gov)

April 25, 2019

5/11/2018

A Study of E6011 in Participants With Active Crohn's Disease

Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease

Crohn's Disease

Drug: E6011;Drug: Placebo

EA Pharma Co., Ltd.

NULL

Recruiting

18 Years

64 Years

All

Phase 2

Czechia;Hungary;Japan;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

EUCTR2018-002629-51-SE
(EUCTR)

23/04/2019

29/01/2019

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

United States;France;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden

187

EUCTR2017-001225-41-SI
(EUCTR)

19/04/2019

06/03/2019

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden

188

EUCTR2017-000725-12-GB
(EUCTR)

17/04/2019

22/10/2018

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom

189

EUCTR2017-003090-34-NL
(EUCTR)

16/04/2019

19/12/2018

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Netherlands BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of

190

EUCTR2017-001976-48-DK
(EUCTR)

15/04/2019

29/01/2019

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Bouvet Island;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

EUCTR2018-002109-70-HU
(EUCTR)

15/04/2019

20/11/2018

A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel disease

Early phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable

Active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

EA Pharma Co., Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Poland;Japan

192

EUCTR2018-002064-15-NL
(EUCTR)

15/04/2019

Patient preference model: treatment of perianal fistulas in Crohn's disease

Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial

Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab
Trade Name: Humira
Product Name: Adalimumab

Academic Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 4

Netherlands

193

NCT03942120
(ClinicalTrials.gov)

April 8, 2019

7/5/2019

Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)

Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA

Crohn Disease

Drug: Ustekinumab

Janssen Korea, Ltd., Korea

NULL

Recruiting

18 Years

N/A

All

Korea, Republic of

194

EUCTR2018-001272-37-HR
(EUCTR)

05/04/2019

17/05/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease

Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of

195

NCT03816345
(ClinicalTrials.gov)

April 4, 2019

24/1/2019

Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer

A 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 Neoplasm

Biological: Nivolumab

National Cancer Institute (NCI)

NULL

Recruiting

18 Years

N/A

All

264

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

NCT03712826
(ClinicalTrials.gov)

April 2019

16/8/2018

Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

Crohn Disease

Drug: Anti-TNF Drug;Drug: Ustekinumab

Hospices Civils de Lyon

NULL

Recruiting

18 Years

N/A

All

N/A

France

197

NCT03884439
(ClinicalTrials.gov)

March 18, 2019

4/3/2019

Infliximab 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 Colitis

Drug: Infliximab [infliximab biosimilar 3]

Pfizer

NULL

Recruiting

N/A

All

300

Japan

198

EUCTR2017-002195-13-PT
(EUCTR)

18/03/2019

23/07/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan

199

EUCTR2018-003303-19-PL
(EUCTR)

15/03/2019

23/01/2019

A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.

A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease.

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Reistone Biopharma Company Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 2

United States;Poland;Ukraine;China

200

EUCTR2017-001226-18-IE
(EUCTR)

08/03/2019

05/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

EUCTR2017-001225-41-IE
(EUCTR)

08/03/2019

13/03/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

202

EUCTR2017-001240-35-IE
(EUCTR)

08/03/2019

05/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

203

NCT03706456
(ClinicalTrials.gov)

March 6, 2019

11/10/2018

Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease

A 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 Disease

Complex Perianal Fistulas in Adult Patients With Crohn's Disease

Biological: Darvadstrocel

Takeda

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

Japan

204

NCT03901937
(ClinicalTrials.gov)

March 1, 2019

12/3/2019

The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease

Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China

Crohn Disease

Drug: ?-3 polyunsaturated fatty acid;Procedure: Intestinal surgery for Crohn's Disease

Sir Run Run Shaw Hospital

NULL

Recruiting

18 Years

75 Years

All

158

Phase 4

China

205

EUCTR2017-000617-23-GB
(EUCTR)

28/02/2019

11/04/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

EUCTR2017-000575-88-GB
(EUCTR)

28/02/2019

11/04/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305

Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1032

Phase 3

Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan

207

EUCTR2017-000574-11-GR
(EUCTR)

26/02/2019

27/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Ulcerative colitis or Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2453

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

208

EUCTR2017-000576-29-GR
(EUCTR)

26/02/2019

25/02/2019

Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

209

EUCTR2017-000617-23-GR
(EUCTR)

26/02/2019

21/02/2019

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan

210

EUCTR2018-001272-37-PT
(EUCTR)

25/02/2019

30/07/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

EUCTR2018-001272-37-AT
(EUCTR)

25/02/2019

21/09/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of

212

EUCTR2017-003090-34-DE
(EUCTR)

18/02/2019

15/11/2018

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD

Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Denmark;Austria

213

EUCTR2016-005199-90-SK
(EUCTR)

14/02/2019

14/02/2018

Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease.

An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study - RHB-104-04 and MAP (US2)

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Australia;Israel;New Zealand

214

NCT03681652
(ClinicalTrials.gov)

February 11, 2019

20/9/2018

Post-Operative Crohn's Disease Outcome in Children

Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study

Crohn Disease

Drug: Azathioprine;Drug: Anti-TNF Drug

Schneider Children's Medical Center, Israel

NULL

Recruiting

6 Years

18 Years

All

100

Israel

215

NCT03627091
(ClinicalTrials.gov)

February 6, 2019

24/7/2018

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Crohn's Disease

Drug: Ontamalimab;Other: Placebo

Shire

NULL

Active, not recruiting

16 Years

80 Years

All

Phase 3

Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom;United States;Australia;Argentina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

EUCTR2017-003090-34-AT
(EUCTR)

05/02/2019

11/10/2018

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of

217

NCT03752970
(ClinicalTrials.gov)

February 5, 2019

22/11/2018

A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease

Crohn Disease

Drug: Spesolimab;Drug: Placebo

Boehringer Ingelheim

NULL

Recruiting

18 Years

75 Years

All

Phase 2

Austria;Belgium;Germany;Hungary;Korea, Republic of;Netherlands;Spain

218

EUCTR2017-004997-32-HU
(EUCTR)

04/02/2019

04/04/2019

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

219

EUCTR2017-004295-55-PT
(EUCTR)

04/02/2019

01/10/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

220

EUCTR2017-004997-32-NL
(EUCTR)

30/01/2019

06/12/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

EUCTR2016-000634-21-FR
(EUCTR)

28/01/2019

08/11/2018

A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

693

Phase 2

United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of

222

NCT03650413
(ClinicalTrials.gov)

January 14, 2019

16/8/2018

An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Ulcerative Colitis;Crohn's Disease

Drug: UTTR1147A

Genentech, Inc.

NULL

Recruiting

18 Years

80 Years

All

320

Phase 2

United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France

223

EUCTR2017-000575-88-HR
(EUCTR)

11/01/2019

16/05/2019

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Serbia;Czechia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand

224

EUCTR2017-000617-23-HR
(EUCTR)

11/01/2019

16/05/2019

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

225

EUCTR2018-001272-37-FR
(EUCTR)

10/01/2019

23/07/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

EUCTR2018-002629-51-NL
(EUCTR)

08/01/2019

12/11/2018

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

France;United States;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden

227

EUCTR2017-004997-32-GB
(EUCTR)

04/01/2019

09/10/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

228

NCT04606017
(ClinicalTrials.gov)

January 1, 2019

25/10/2020

Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response in Patients With Crohn's Disease

Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response

Crohn Disease;Vitamin D Deficiency;Vitamin D Supplement

Drug: Caltrate Pill

Second Affiliated Hospital of Wenzhou Medical University

NULL

Completed

N/A

All

China

229

NCT03773237
(ClinicalTrials.gov)

December 31, 2018

12/11/2018

Intralipid Versus SMOFlipid in HPN Patients

Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.

Short Bowel Syndrome;Intestinal Fistula;Crohn Disease;Intestinal Obstruction

Dietary Supplement: SMOFLipid;Dietary Supplement: Intralipid

Mayo Clinic

NULL

Recruiting

18 Years

75 Years

All

100

N/A

United States

230

EUCTR2017-001225-41-HR
(EUCTR)

31/12/2018

21/05/2019

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

EUCTR2018-002925-47-ES
(EUCTR)

28/12/2018

16/11/2018

prediction of response to therapy in inflammatory bowel disease

Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches

Inflammatory bowel disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Fundación de Investigación Biomédica del Hospital Universitario de La Princesa

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 4

Spain

232

EUCTR2017-001976-48-DE
(EUCTR)

20/12/2018

22/08/2018

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Portugal;Czechia;Taiwan;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

233

EUCTR2017-001240-35-HR
(EUCTR)

20/12/2018

21/05/2019

Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

234

NCT03782376
(ClinicalTrials.gov)

December 20, 2018

11/12/2018

A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: 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 2

Janssen-Cilag Ltd.

NULL

Recruiting

18 Years

N/A

All

200

Phase 3

United States;Austria;France;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom

235

EUCTR2017-001226-18-HR
(EUCTR)

19/12/2018

21/05/2019

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

ChiCTR1800019958

2018-12-16

2018-12-09

Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease

Crohn's disease

Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;

Daping Hospital, Army Medical University (Third Military Medical University)

NULL

Recruiting

Both

Case series:60;

China

237

EUCTR2017-004997-32-IE
(EUCTR)

14/12/2018

13/12/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

238

EUCTR2018-002001-65-GB
(EUCTR)

13/12/2018

01/10/2018

A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s Disease

A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

University of Birmingham

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

United Kingdom

239

EUCTR2017-004295-55-BE
(EUCTR)

13/12/2018

30/03/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

240

EUCTR2018-002629-51-ES
(EUCTR)

12/12/2018

16/11/2018

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

France;United States;Spain;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

241

EUCTR2017-004997-32-ES
(EUCTR)

10/12/2018

17/09/2018

A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease

A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE

Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Roche Farma, S.A por delegación de Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

242

NCT03759288
(ClinicalTrials.gov)

December 7, 2018

20/11/2018

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease;IBD

Drug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira ®;Drug: Placebo

Allergan

NULL

Recruiting

16 Years

80 Years

All

1140

Phase 2;Phase 3

United States;Canada;Puerto Rico

243

NCT03574948
(ClinicalTrials.gov)

December 6, 2018

22/6/2018

5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores

Multicentric, 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 Scores

Crohn Disease;Ulcerative Colitis;Fatigue;Remission

Drug: 5-HTP;Drug: Placebo oral capsule

University Hospital, Ghent

NULL

Recruiting

18 Years

60 Years

All

180

Phase 2

Belgium

244

EUCTR2018-001272-37-DE
(EUCTR)

04/12/2018

26/07/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

245

EUCTR2017-004294-14-DK
(EUCTR)

30/11/2018

27/08/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

535

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

246

EUCTR2017-004295-55-DK
(EUCTR)

30/11/2018

27/08/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

247

EUCTR2017-003090-34-BE
(EUCTR)

28/11/2018

12/10/2018

A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD

Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

SCS Boehringer Ingelheim Comm.V

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of

248

EUCTR2018-001272-37-GR
(EUCTR)

28/11/2018

09/11/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma US, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany;Serbia

249

EUCTR2017-001976-48-ES
(EUCTR)

23/11/2018

17/07/2018

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 2

United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of

250

NCT03635112
(ClinicalTrials.gov)

November 19, 2018

31/7/2018

Efficacy and Safety of TD-1473 in Crohn's Disease

A 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

Crohn's Disease

Drug: Placebo;Drug: TD-1473

Theravance Biopharma

NULL

Recruiting

18 Years

N/A

All

160

Phase 2

United States;Australia;Austria;Bulgaria;Croatia;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

251

EUCTR2018-001272-37-GB
(EUCTR)

15/11/2018

03/10/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - DIONE - Efficacy and Safety of TD-1473 in Crohn’s Disease

Moderately-to-Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

252

EUCTR2017-000617-23-DE
(EUCTR)

13/11/2018

28/05/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

253

NCT03623932
(ClinicalTrials.gov)

November 13, 2018

4/7/2018

Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease

Crohn Disease

Drug: immunosuppressor/TNFalpha;Behavioral: Hypnosis

University Hospital, Grenoble

NULL

Recruiting

18 Years

65 Years

All

N/A

France

254

EUCTR2017-000575-88-DE
(EUCTR)

13/11/2018

28/05/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan;Lithuania;Austria;Russian Federation;Israel;United States;Serbia

255

EUCTR2018-001272-37-ES
(EUCTR)

11/11/2018

09/08/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

256

EUCTR2017-004293-33-SI
(EUCTR)

06/11/2018

12/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden

257

EUCTR2017-004295-55-SI
(EUCTR)

06/11/2018

13/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

258

EUCTR2017-004294-14-SI
(EUCTR)

06/11/2018

13/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

259

EUCTR2015-003759-23-NO
(EUCTR)

02/11/2018

07/12/2020

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand

260

EUCTR2018-001382-17-GB
(EUCTR)

30/10/2018

24/06/2019

An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.

Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial - STATIC

Inactive Crohn’s Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

INN or Proposed INN: MESALAZINE

Alimentiv Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1580

Phase 4

Canada;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

261

EUCTR2017-004294-14-PT
(EUCTR)

29/10/2018

16/07/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

262

EUCTR2017-005151-83-DE
(EUCTR)

26/10/2018

09/07/2018

Treatment of Crohn's disease with Ustekinumab in clinical practice

INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUS

Trade Name: STELARA
Product Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA
Product Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Charité Universitätsmedizin Berlin

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 4

Germany

263

EUCTR2017-004209-41-BE
(EUCTR)

25/10/2018

21/08/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

264

NCT03723447
(ClinicalTrials.gov)

October 23, 2018

26/10/2018

Intraoperative 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 Trial

Pain, Postoperative;Crohn Disease;Inflammatory Bowel Diseases;Colorectal Cancer;Gastrointestinal Cancer;Gastrointestinal Disease;Digestive System Disease;Pain;Pain, Neuropathic;Intestinal Disease

Drug: Liposomal bupivacaine;Drug: Bupivacaine /epinephrine/dexamethasone

Cedars-Sinai Medical Center

NULL

Active, not recruiting

18 Years

90 Years

All

100

Phase 4

United States

265

EUCTR2017-004294-14-NL
(EUCTR)

22/10/2018

12/03/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

266

EUCTR2017-004295-55-NL
(EUCTR)

22/10/2018

12/03/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

267

EUCTR2017-004293-33-NL
(EUCTR)

22/10/2018

12/03/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

268

EUCTR2018-001272-37-HU
(EUCTR)

16/10/2018

16/08/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

269

EUCTR2017-004209-41-DE
(EUCTR)

16/10/2018

21/06/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

270

EUCTR2017-004293-33-FI
(EUCTR)

10/10/2018

30/07/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

271

EUCTR2017-004294-14-FI
(EUCTR)

10/10/2018

30/07/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

272

EUCTR2017-004295-55-FI
(EUCTR)

10/10/2018

31/07/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

273

EUCTR2018-001272-37-BG
(EUCTR)

09/10/2018

31/08/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

274

EUCTR2017-000617-23-PT
(EUCTR)

08/10/2018

01/06/2018

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan

275

EUCTR2017-000576-29-BE
(EUCTR)

08/10/2018

02/05/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

EUCTR2017-000617-23-BE
(EUCTR)

08/10/2018

02/05/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan

277

EUCTR2017-003359-43-DE
(EUCTR)

04/10/2018

19/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease

Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600 -15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

Turkey;Austria;Hungary;Czech Republic;Canada;Belgium;United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Poland;Croatia;Georgia;Germany

278

EUCTR2017-000617-23-EE
(EUCTR)

03/10/2018

11/06/2018

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

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;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan

279

EUCTR2017-000574-11-EE
(EUCTR)

03/10/2018

11/06/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Ulcerative colitis or Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Serbia;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

280

EUCTR2017-004209-41-NL
(EUCTR)

01/10/2018

27/06/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira ®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

281

EUCTR2017-004209-41-BG
(EUCTR)

26/09/2018

19/07/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of

282

NCT03606499
(ClinicalTrials.gov)

September 26, 2018

20/7/2018

Real-world Effectiveness of Ustekinumab in Participants Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases

Effectiveness of Ustekinumab in Patients Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-Mediated Inflammatory Diseases in a Real-world Setting

Crohn Disease

Drug: Ustekinumab

Janssen Cilag S.A.S.

NULL

Recruiting

18 Years

N/A

All

125

France

283

EUCTR2017-003359-43-AT
(EUCTR)

24/09/2018

20/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany

284

EUCTR2017-004295-55-DE
(EUCTR)

21/09/2018

21/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

285

EUCTR2017-004294-14-BE
(EUCTR)

20/09/2018

28/03/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

286

JPRN-JapicCTI-183950

20/9/2018

07/05/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Crohn's Disease

Intervention 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.

NULL

recruiting

BOTH

2000

Phase 2;Phase 3

Japan, North America

287

EUCTR2017-000617-23-NL
(EUCTR)

17/09/2018

17/04/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

288

EUCTR2017-000575-88-NL
(EUCTR)

17/09/2018

19/04/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1032

Phase 3

Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan

289

EUCTR2017-000617-23-BG
(EUCTR)

14/09/2018

10/07/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

290

EUCTR2017-000576-29-BG
(EUCTR)

14/09/2018

24/07/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

291

EUCTR2017-001240-35-BE
(EUCTR)

13/09/2018

02/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

292

EUCTR2017-001976-48-HU
(EUCTR)

13/09/2018

05/07/2018

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 2

United States;Portugal;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Romania;Australia;Denmark;Germany;Korea, Republic of

293

EUCTR2017-001226-18-BE
(EUCTR)

13/09/2018

02/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

294

EUCTR2017-001225-41-BE
(EUCTR)

13/09/2018

19/12/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

295

EUCTR2017-001226-18-CZ
(EUCTR)

12/09/2018

19/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

296

EUCTR2017-001225-41-CZ
(EUCTR)

12/09/2018

20/04/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

297

EUCTR2017-004292-31-BE
(EUCTR)

10/09/2018

23/03/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan

298

EUCTR2017-002195-13-NL
(EUCTR)

10/09/2018

30/04/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Latvia;Tunisia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan

299

EUCTR2017-002195-13-HR
(EUCTR)

07/09/2018

16/05/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;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

300

EUCTR2017-004292-31-DE
(EUCTR)

06/09/2018

06/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

301

NCT03615378
(ClinicalTrials.gov)

August 30, 2018

16/7/2018

Maintenance Dosing of Vitamin D in Crohn's Disease

A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission

Crohns Disease;Vitamin D Deficiency

Dietary Supplement: 5000 IU D3;Dietary Supplement: 1000 IU D3;Dietary Supplement: Placebo

Cedars-Sinai Medical Center

NULL

Terminated

18 Years

N/A

All

Early Phase 1

United States

302

EUCTR2017-000576-29-PT
(EUCTR)

27/08/2018

01/06/2018

Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1032

Phase 3

Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina

303

EUCTR2017-004209-41-CZ
(EUCTR)

27/08/2018

13/06/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

304

NCT03452501
(ClinicalTrials.gov)

August 26, 2018

26/2/2018

Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

An 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 CD

Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis

Drug: Infliximab

Hikma Pharmaceuticals LLC

NULL

Active, not recruiting

18 Years

N/A

All

150

Saudi Arabia

305

EUCTR2017-004209-41-GB
(EUCTR)

24/08/2018

22/06/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

306

EUCTR2017-004294-14-DE
(EUCTR)

23/08/2018

20/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

307

EUCTR2017-001976-48-GB
(EUCTR)

23/08/2018

26/06/2018

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan

308

EUCTR2017-001976-48-PL
(EUCTR)

23/08/2018

17/07/2018

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

309

NCT03467958
(ClinicalTrials.gov)

August 22, 2018

12/3/2018

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ozanimod

Celgene

NULL

Recruiting

12 Years

75 Years

All

1200

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil

310

EUCTR2017-001240-35-BG
(EUCTR)

22/08/2018

05/06/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

311

EUCTR2017-001225-41-BG
(EUCTR)

22/08/2018

05/06/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

312

EUCTR2017-001226-18-BG
(EUCTR)

22/08/2018

05/06/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

313

NCT03546868
(ClinicalTrials.gov)

August 14, 2018

10/5/2018

Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease

Phase 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 Disease

Drug: [18F]FSPG

Asan Foundation

NULL

Completed

19 Years

79 Years

All

Phase 2

Korea, Republic of

314

EUCTR2017-002195-13-PL
(EUCTR)

13/08/2018

25/05/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Georgia;Germany;New Zealand;Japan

315

EUCTR2017-002195-13-LV
(EUCTR)

10/08/2018

21/05/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Tunisia;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

316

EUCTR2017-004294-14-SE
(EUCTR)

08/08/2018

08/03/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

317

EUCTR2017-004295-55-SE
(EUCTR)

08/08/2018

08/03/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

318

EUCTR2017-004293-33-PT
(EUCTR)

06/08/2018

27/03/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn¿s Disease

Moderately to Severely Active Crohn¿s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

319

EUCTR2017-004209-41-PL
(EUCTR)

03/08/2018

20/06/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

320

EUCTR2017-002195-13-ES
(EUCTR)

30/07/2018

21/05/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

321

EUCTR2017-004209-41-FR
(EUCTR)

30/07/2018

14/06/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Russian Federation;United Kingdom;Italy;Serbia;United States;Spain;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

322

EUCTR2017-002195-13-GR
(EUCTR)

27/07/2018

17/07/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 2;Phase 3

Serbia;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

323

EUCTR2017-000576-29-EE
(EUCTR)

25/07/2018

11/06/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

324

EUCTR2017-000617-23-HU
(EUCTR)

24/07/2018

15/05/2018

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

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;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan

325

EUCTR2017-000576-29-HU
(EUCTR)

24/07/2018

15/05/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

326

NCT03449069
(ClinicalTrials.gov)

July 23, 2018

22/2/2018

Pediatric MSC-AFP Sub-study for Crohn's Fistula

A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study

Fistula in Ano;Crohn Disease

Drug: MSC-AFP

Mayo Clinic

NULL

Recruiting

12 Years

17 Years

All

Phase 1

United States

327

EUCTR2016-003191-50-SE
(EUCTR)

22/07/2018

14/09/2017

A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

328

EUCTR2017-003359-43-HR
(EUCTR)

19/07/2018

16/05/2019

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

Moderate To Severe Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

329

EUCTR2017-001737-85-NL
(EUCTR)

17/07/2018

03/04/2018

Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy

Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy - ADD UP

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: albendazole (Eskazole)
Product Name: albendazole

academic medical centre

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 4

Netherlands

330

EUCTR2017-000617-23-ES
(EUCTR)

16/07/2018

14/05/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

331

EUCTR2017-004294-14-GB
(EUCTR)

13/07/2018

26/06/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

332

EUCTR2017-004292-31-GB
(EUCTR)

13/07/2018

26/06/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand

333

EUCTR2017-000576-29-ES
(EUCTR)

11/07/2018

21/05/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina

334

EUCTR2018-001546-33-GB
(EUCTR)

11/07/2018

14/05/2018

The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease

IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0

Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Flixabi
Product Name: Flixabi
INN or Proposed INN: Infliximab

University Southampton Hospital NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

335

EUCTR2017-000576-29-SK
(EUCTR)

10/07/2018

17/05/2018

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

336

EUCTR2017-000617-23-SK
(EUCTR)

10/07/2018

17/05/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

983

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan

337

EUCTR2016-003123-32-SE
(EUCTR)

09/07/2018

08/09/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

338

EUCTR2017-004292-31-DK
(EUCTR)

09/07/2018

09/04/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan

339

NCT03860571
(ClinicalTrials.gov)

July 6, 2018

3/2/2019

Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

A 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 Volunteers

Ulcerative Colitis;Crohn Disease

Drug: BT-11 Placebo;Drug: BT-11 Active

Landos Biopharma Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

340

EUCTR2017-000575-88-AT
(EUCTR)

06/07/2018

19/04/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

341

EUCTR2017-000617-23-AT
(EUCTR)

06/07/2018

19/04/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

342

EUCTR2017-001240-35-LT
(EUCTR)

05/07/2018

23/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

343

EUCTR2017-002195-13-DE
(EUCTR)

03/07/2018

01/03/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;North Macedonia;Colombia;Italy;France;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan;Taiwan;Saudi Arabia;Slovakia

344

NCT03662919
(ClinicalTrials.gov)

July 2, 2018

6/9/2018

One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study

Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, Ulcerative

Drug: Infliximab;Drug: Adalimumab

Biogen

NULL

Recruiting

6 Years

N/A

All

3000

France

345

NCT03467620
(ClinicalTrials.gov)

July 2018

5/3/2018

Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study

Crohn Disease;Inflammatory Bowel Diseases;Cannabis

Drug: Cannabidiol;Drug: Placebo oral capsule

University of Illinois at Chicago

NULL

Withdrawn

18 Years

N/A

All

Phase 2;Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

346

NCT03599622
(ClinicalTrials.gov)

June 29, 2018

11/7/2018

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

Granulomatous Colitis;Crohn's Disease;Crohn's Enteritis;Granulomatous Enteritis

Drug: BMS-986165;Other: Placebo

Bristol-Myers Squibb

NULL

Recruiting

18 Years

75 Years

All

240

Phase 2

United States;Australia;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom

347

EUCTR2017-002195-13-LT
(EUCTR)

28/06/2018

20/04/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan

348

EUCTR2017-001225-41-DK
(EUCTR)

27/06/2018

07/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

349

NCT03464097
(ClinicalTrials.gov)

June 27, 2018

26/2/2018

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ozanimod;Other: Placebo

Celgene

NULL

Recruiting

12 Years

75 Years

All

485

Phase 3

350

EUCTR2017-000574-11-BE
(EUCTR)

27/06/2018

14/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Ulcerative colitis or Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

351

EUCTR2017-001226-18-DE
(EUCTR)

26/06/2018

09/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

352

EUCTR2017-001225-41-DE
(EUCTR)

26/06/2018

08/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

353

EUCTR2017-003359-43-SK
(EUCTR)

26/06/2018

19/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Georgia;Germany

354

EUCTR2017-001240-35-DE
(EUCTR)

26/06/2018

28/02/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

355

NCT03559517
(ClinicalTrials.gov)

June 25, 2018

9/5/2018

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)

Crohn's Disease

Biological: Ontamalimab;Other: Placebo

Shire

NULL

Terminated

16 Years

80 Years

All

Phase 3

United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

356

NCT03472690
(ClinicalTrials.gov)

June 25, 2018

8/3/2018

QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease

A 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 Disease

Crohn Disease

Biological: QBECO-SSI;Other: Placebo

Qu Biologics Inc.

NULL

Active, not recruiting

18 Years

N/A

All

Phase 2

Canada

357

EUCTR2017-001240-35-DK
(EUCTR)

25/06/2018

10/03/2018

Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

358

EUCTR2017-003359-43-HU
(EUCTR)

21/06/2018

25/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand

359

EUCTR2017-004209-41-ES
(EUCTR)

21/06/2018

21/05/2018

A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

360

EUCTR2017-002195-13-CZ
(EUCTR)

19/06/2018

20/04/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

361

EUCTR2017-004295-55-HR
(EUCTR)

19/06/2018

07/12/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

362

EUCTR2017-004292-31-HR
(EUCTR)

18/06/2018

07/12/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan

363

EUCTR2017-002195-13-SK
(EUCTR)

18/06/2018

26/04/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan

364

EUCTR2017-004294-14-HR
(EUCTR)

18/06/2018

07/12/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

365

EUCTR2017-000575-88-LT
(EUCTR)

15/06/2018

20/04/2018

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1032

Phase 3

United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

366

EUCTR2017-000617-23-LT
(EUCTR)

15/06/2018

20/04/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

367

EUCTR2017-002195-13-BE
(EUCTR)

15/06/2018

30/03/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan

368

EUCTR2017-001240-35-EE
(EUCTR)

14/06/2018

07/05/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;United States;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

369

EUCTR2017-001226-18-EE
(EUCTR)

14/06/2018

07/05/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

370

NCT04329481
(ClinicalTrials.gov)

June 12, 2018

29/3/2020

The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients

Ulcerative Colitis;Crohn Disease;Inflammatory Bowel Diseases

Dietary Supplement: Mycodigest supplement

Tel-Aviv Sourasky Medical Center

NULL

Recruiting

18 Years

70 Years

All

100

N/A

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

371

NCT03566823
(ClinicalTrials.gov)

June 11, 2018

9/5/2018

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)

Crohn's Disease

Biological: Ontamalimab;Other: Placebo

Shire

NULL

Terminated

16 Years

80 Years

All

Phase 3

United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Turkey;Ukraine

372

NCT03142321
(ClinicalTrials.gov)

June 8, 2018

3/5/2017

Defining Predictors of RT Response to Vedolizumab in IBD

Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers

Crohn Disease of Small Intestine

Drug: Vedolizumab 300 MG Injection [Entyvio]

Washington University School of Medicine

NULL

Recruiting

18 Years

N/A

All

Phase 4

United States

373

EUCTR2017-004293-33-BG
(EUCTR)

06/06/2018

20/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

374

EUCTR2017-004292-31-BG
(EUCTR)

06/06/2018

20/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand

375

EUCTR2017-004294-14-BG
(EUCTR)

06/06/2018

20/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

376

EUCTR2017-001226-18-LT
(EUCTR)

06/06/2018

23/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

377

EUCTR2017-001225-41-LT
(EUCTR)

06/06/2018

23/03/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

378

EUCTR2017-004295-55-BG
(EUCTR)

06/06/2018

20/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

379

NCT03477032
(ClinicalTrials.gov)

June 1, 2018

19/3/2018

FMT in Inflammatory Bowel Disease

Faecal Transplantation in Inflammatory Bowel Disease

Faecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic Colitis

Biological: Faecal Microbiota Transplantation

St Vincent's Hospital Melbourne

NULL

Recruiting

18 Years

65 Years

All

Australia

380

NCT03559660
(ClinicalTrials.gov)

May 30, 2018

5/6/2018

CUP 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 Disease

Drug: Certolizumab Pegol

UCB Biopharma S.P.R.L.

NULL

Available

18 Years

N/A

All

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

381

EUCTR2017-003359-43-BE
(EUCTR)

28/05/2018

06/03/2019

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany

382

EUCTR2017-001226-18-DK
(EUCTR)

28/05/2018

16/02/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

383

EUCTR2017-002195-13-AT
(EUCTR)

28/05/2018

18/04/2018

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 2;Phase 3

384

EUCTR2014-002311-41-NL
(EUCTR)

25/05/2018

18/12/2017

A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE

Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 4

France;Belgium;Germany;Netherlands;United Kingdom;Sweden

385

EUCTR2017-002258-36-NL
(EUCTR)

25/05/2018

17/10/2017

Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrence

A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER)

Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin -EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA

ALFASIGMA S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Spain;Belgium;Germany;Netherlands;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

EUCTR2017-003359-43-LT
(EUCTR)

24/05/2018

17/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

255

Phase 2

Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany

387

EUCTR2016-003153-15-BE
(EUCTR)

24/05/2018

07/02/2018

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Czechia;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

388

EUCTR2017-004295-55-ES
(EUCTR)

23/05/2018

01/03/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

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;Mexico;Canada;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic

389

EUCTR2017-003359-43-PL
(EUCTR)

23/05/2018

24/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany

390

EUCTR2017-004293-33-SE
(EUCTR)

23/05/2018

08/03/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

391

EUCTR2017-004292-31-LV
(EUCTR)

21/05/2018

31/01/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

392

EUCTR2017-004294-14-LV
(EUCTR)

21/05/2018

31/01/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

393

EUCTR2017-001226-18-LV
(EUCTR)

21/05/2018

07/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

Ukraine;Chile;Israel;Russian Federation;Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Colombia;Switzerland;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden

394

EUCTR2017-004295-55-LV
(EUCTR)

21/05/2018

31/01/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

395

EUCTR2017-001240-35-HU
(EUCTR)

18/05/2018

07/03/2018

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

396

EUCTR2017-001225-41-NL
(EUCTR)

18/05/2018

08/03/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

397

EUCTR2017-004295-55-GB
(EUCTR)

18/05/2018

27/06/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

398

EUCTR2017-001225-41-HU
(EUCTR)

18/05/2018

07/03/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

399

EUCTR2017-001226-18-HU
(EUCTR)

18/05/2018

07/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

400

EUCTR2017-001240-35-NL
(EUCTR)

18/05/2018

08/03/2018

Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

401

EUCTR2017-003649-10-GB
(EUCTR)

15/05/2018

11/12/2017

A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease

A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE

Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

Spain;Poland;Belgium;Germany;United Kingdom

402

EUCTR2017-001225-41-PT
(EUCTR)

14/05/2018

19/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

Canada;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Brazil;United Kingdom;Egypt

403

EUCTR2017-001226-18-PT
(EUCTR)

14/05/2018

01/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

United States;Portugal;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

404

EUCTR2017-001240-35-PT
(EUCTR)

14/05/2018

01/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

United States;Portugal;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

405

EUCTR2017-002231-41-NL
(EUCTR)

14/05/2018

26/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

406

EUCTR2016-003123-32-HR
(EUCTR)

14/05/2018

29/05/2018

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

407

EUCTR2016-003191-50-HR
(EUCTR)

14/05/2018

29/05/2018

A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan

408

EUCTR2017-001225-41-ES
(EUCTR)

10/05/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden

409

EUCTR2017-001240-35-PL
(EUCTR)

10/05/2018

09/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

410

EUCTR2017-004292-31-ES
(EUCTR)

10/05/2018

23/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

411

EUCTR2017-001240-35-ES
(EUCTR)

10/05/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden

412

EUCTR2017-001226-18-PL
(EUCTR)

10/05/2018

12/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

413

EUCTR2017-001226-18-ES
(EUCTR)

09/05/2018

10/05/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

414

EUCTR2016-003179-23-BE
(EUCTR)

07/05/2018

16/02/2018

This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)

Small Bowel Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany

415

EUCTR2016-003123-32-LT
(EUCTR)

07/05/2018

23/01/2018

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

855

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

416

EUCTR2016-003191-50-LT
(EUCTR)

07/05/2018

01/02/2018

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

417

EUCTR2016-003190-17-HR
(EUCTR)

04/05/2018

16/05/2019

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

418

EUCTR2017-004292-31-CZ
(EUCTR)

03/05/2018

31/01/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan

419

EUCTR2016-002918-43-DK
(EUCTR)

03/05/2018

15/02/2018

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;France;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden

420

EUCTR2017-004294-14-CZ
(EUCTR)

03/05/2018

01/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

421

EUCTR2016-000522-18-BE
(EUCTR)

02/05/2018

08/01/2018

Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy

Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

PIBDNet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 4

France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom

422

EUCTR2017-003649-10-BE
(EUCTR)

02/05/2018

27/02/2018

Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

United States;Poland;Spain;Belgium;Germany;United Kingdom

423

ChiCTR1800015174

2018-05-01

2018-03-12

Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease

Crohn's disease

control group:placebo;Vitamin D:800IU Vitamin D;

Gudangdong General Hospital, Guangdong Academy of Medical Sciences

NULL

Pending

Both

control group:32;Vitamin D:32;

China

424

EUCTR2017-003649-10-DE
(EUCTR)

30/04/2018

07/02/2018

Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;Poland;Belgium;Spain;Germany;United Kingdom

425

EUCTR2017-004293-33-GR
(EUCTR)

27/04/2018

28/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

426

EUCTR2017-004295-55-GR
(EUCTR)

27/04/2018

01/03/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

427

EUCTR2017-004294-14-GR
(EUCTR)

27/04/2018

28/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

Russian Federation;Switzerland;Australia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand

428

EUCTR2017-000574-11-HR
(EUCTR)

27/04/2018

27/08/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

429

EUCTR2017-004293-33-PL
(EUCTR)

26/04/2018

19/03/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

430

EUCTR2017-004292-31-PL
(EUCTR)

26/04/2018

20/04/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

431

EUCTR2017-004294-14-PL
(EUCTR)

26/04/2018

20/03/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

535

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

432

EUCTR2017-004295-55-PL
(EUCTR)

26/04/2018

20/03/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

433

EUCTR2017-004294-14-ES
(EUCTR)

25/04/2018

02/03/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

434

EUCTR2017-004293-33-ES
(EUCTR)

25/04/2018

02/03/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

435

EUCTR2017-003359-43-ES
(EUCTR)

25/04/2018

27/04/2018

A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

255

Phase 2

Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

436

EUCTR2016-000522-18-CZ
(EUCTR)

24/04/2018

25/04/2018

Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Azathioprin
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

PIBDNet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 4

France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom

437

EUCTR2017-000574-11-PT
(EUCTR)

23/04/2018

22/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

438

EUCTR2017-001226-18-SK
(EUCTR)

17/04/2018

15/11/2017

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

439

EUCTR2017-001225-41-SK
(EUCTR)

17/04/2018

15/11/2017

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

440

EUCTR2017-001240-35-SK
(EUCTR)

17/04/2018

15/11/2017

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

441

NCT03466411
(ClinicalTrials.gov)

April 13, 2018

8/3/2018

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Guselkumab Dose 4;Drug: Guselkumab Dose 5;Drug: Guselkumab;Drug: Ustekinumab;Drug: Placebo

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

N/A

All

2000

Phase 2;Phase 3

United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Netherlands;New Zealand;North Macedonia;Poland;Portugal;Puerto Rico;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;India;Ireland;Macedonia, The Former Yugoslav Republic of;Slovenia;South Africa

442

EUCTR2017-000574-11-DE
(EUCTR)

10/04/2018

25/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2453

Phase 3

443

NCT03105102
(ClinicalTrials.gov)

April 9, 2018

4/4/2017

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

Crohn's Disease

Drug: Placebo for Risankizumab SC;Drug: Risankizumab IV;Drug: Placebo for Risankizumab IV;Drug: Risankizumab SC

AbbVie

NULL

Enrolling by invitation

18 Years

80 Years

All

1250

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey

444

EUCTR2016-004112-35-SE
(EUCTR)

04/04/2018

21/06/2017

A 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 disease

Low-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study

Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA

SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

Sweden

445

NCT03464136
(ClinicalTrials.gov)

March 29, 2018

7/3/2018

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

Crohn Disease

Biological: Placebo for Ustekinumab;Biological: Placebo for Adalimumab;Biological: Ustekinumab (6 mg/kg);Biological: Ustekinumab (90 mg);Biological: Adalimumab (40 mg)

Janssen Scientific Affairs, LLC

NULL

Active, not recruiting

18 Years

N/A

All

386

Phase 3

United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

446

EUCTR2016-000522-18-GB
(EUCTR)

28/03/2018

05/12/2017

Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.

Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL

Paediatric Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

PIBD net

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 4

France;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom

447

EUCTR2017-001240-35-LV
(EUCTR)

28/03/2018

07/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

448

EUCTR2017-001225-41-GB
(EUCTR)

27/03/2018

15/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

449

NCT03478956
(ClinicalTrials.gov)

March 27, 2018

26/3/2018

A 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 Disease

A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease

Ulcerative Colitis;Crohn's Disease

Drug: Etrolizumab

Hoffmann-La Roche

NULL

Active, not recruiting

4 Years

17 Years

All

Phase 1

Belgium;Poland;Spain;United Kingdom;Germany;United States

450

EUCTR2017-001226-18-GB
(EUCTR)

26/03/2018

06/03/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

451

EUCTR2017-001240-35-GB
(EUCTR)

26/03/2018

06/03/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

452

EUCTR2017-004293-33-AT
(EUCTR)

23/03/2018

14/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

453

EUCTR2017-003017-25-PL
(EUCTR)

23/03/2018

19/12/2017

Clinical Study to Evaluate the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE)

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: JNJ-40346527 -AAC
Product Code: PRV-6527 (JNJ-40346527)
Other descriptive name: JNJ-40346527 -AAC

Provention Bio, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Poland;Ukraine;Austria;Russian Federation;Germany

454

EUCTR2017-004295-55-AT
(EUCTR)

23/03/2018

14/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

455

EUCTR2017-004294-14-AT
(EUCTR)

23/03/2018

14/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

456

NCT03345823
(ClinicalTrials.gov)

March 21, 2018

15/11/2017

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Crohn's Disease

Drug: Upadacitinib;Drug: Placebo for Upadacitinib

AbbVie

NULL

Enrolling by invitation

18 Years

75 Years

All

747

Phase 3

United 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

457

NCT03854305
(ClinicalTrials.gov)

March 20, 2018

23/2/2019

Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease

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 CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's

Crohn's Disease

Drug: PRV-6527;Drug: Placebo

Provention Bio, Inc.

NULL

Active, not recruiting

18 Years

75 Years

All

Phase 2

Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine

458

EUCTR2017-002182-21-NL
(EUCTR)

20/03/2018

28/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom

459

EUCTR2017-003017-25-DE
(EUCTR)

20/03/2018

22/02/2018

Clinical 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 Disease

Moderately to severely Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Provention Bio, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany

460

EUCTR2017-004294-14-SK
(EUCTR)

16/03/2018

30/01/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

461

EUCTR2017-004295-55-SK
(EUCTR)

16/03/2018

30/01/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

462

EUCTR2016-002918-43-SK
(EUCTR)

16/03/2018

15/02/2018

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden

463

EUCTR2017-004293-33-SK
(EUCTR)

16/03/2018

30/01/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

464

EUCTR2017-001225-41-SE
(EUCTR)

15/03/2018

12/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

465

EUCTR2017-000574-11-NL
(EUCTR)

15/03/2018

02/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

466

EUCTR2017-001240-35-SE
(EUCTR)

15/03/2018

15/02/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

467

EUCTR2017-003017-25-ES
(EUCTR)

14/03/2018

15/12/2017

Clinical Study to Evaluate the Efficacy and Safety of PRV-6527, an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease

Provention Bio, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany

468

EUCTR2017-000574-11-IE
(EUCTR)

13/03/2018

04/09/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

469

EUCTR2017-001240-35-AT
(EUCTR)

12/03/2018

28/02/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

501

Phase 3

470

EUCTR2017-004293-33-LT
(EUCTR)

12/03/2018

01/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

471

EUCTR2017-001226-18-SE
(EUCTR)

12/03/2018

16/02/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

472

EUCTR2017-001226-18-AT
(EUCTR)

12/03/2018

28/02/2018

A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

645

Phase 3

473

EUCTR2017-004294-14-LT
(EUCTR)

12/03/2018

01/02/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

474

EUCTR2017-004295-55-LT
(EUCTR)

12/03/2018

01/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

475

EUCTR2017-001225-41-LV
(EUCTR)

09/03/2018

14/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

738

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

476

EUCTR2017-004295-55-HU
(EUCTR)

08/03/2018

30/01/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

477

NCT03440385
(ClinicalTrials.gov)

March 7, 2018

14/2/2018

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ozanimod;Other: Placebo

Celgene

NULL

Recruiting

12 Years

75 Years

All

600

Phase 3

United States;Australia;Austria;Bulgaria;Canada;China;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;Brazil

478

NCT03709628
(ClinicalTrials.gov)

March 7, 2018

11/4/2018

A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Crohn Disease

Drug: EB8018 (First-in-class FimH blocker)

Enterome

NULL

Active, not recruiting

18 Years

N/A

All

Phase 1

Austria;France;Germany;Italy

479

EUCTR2017-000574-11-GB
(EUCTR)

06/03/2018

21/09/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

480

EUCTR2017-004293-33-HU
(EUCTR)

06/03/2018

29/01/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

481

EUCTR2017-004294-14-HU
(EUCTR)

06/03/2018

30/01/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

485

Phase 3

482

NCT03329209
(ClinicalTrials.gov)

March 5, 2018

30/10/2017

A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants

An Open-Label, Single-Center, Phase 1 Study to Determine the Pharmacokinetics of Single Intravenous Dose of Vedolizumab 300 mg in Healthy Adult Chinese Subjects

Colitis, Ulcerative;Crohn Disease

Drug: Vedolizumab

Takeda

NULL

Completed

18 Years

45 Years

All

Phase 1

China

483

JPRN-jRCTs021200013

28/02/2018

31/07/2020

A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.

A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST

Crohn's disease
Crohn's disease;D003424

Ustekinumab monotherapy for 32 weeks.

Moroi Rintao

NULL

Recruiting

>= 18age old

<= 75age old

Both

Phase 3

Japan

484

NCT03440372
(ClinicalTrials.gov)

February 27, 2018

14/2/2018

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ozanimod;Other: Placebo

Celgene

NULL

Recruiting

12 Years

75 Years

All

600

Phase 3

United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Moldova, Republic of;Norway;Poland;Romania;Russian Federation;Saudi Arabia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil

485

NCT03283085
(ClinicalTrials.gov)

February 27, 2018

12/9/2017

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Crohn's Disease;Ulcerative Colitis

Drug: 25 mg Ontamalimab;Drug: 75 mg Ontamalimab

Shire

NULL

Recruiting

16 Years

80 Years

All

451

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

486

JPRN-UMIN000030884

2018/02/27

20/02/2018

Crohn's disease

Ustekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.

Tohoku University Hospital, Division of Gastroenterology

NULL

Recruiting

18years-old

75years-old

Male and Female

Phase 3

Japan

487

NCT03801928
(ClinicalTrials.gov)

February 23, 2018

11/12/2018

Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA

Inflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC)

Drug: Inflectra

Pfizer

NULL

Completed

18 Years

N/A

All

118

United States;Canada

488

EUCTR2016-003179-23-AT
(EUCTR)

19/02/2018

16/02/2018

This 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)

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

489

EUCTR2017-001225-41-AT
(EUCTR)

19/02/2018

07/02/2018

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

747

Phase 3

490

EUCTR2016-003153-15-AT
(EUCTR)

19/02/2018

06/02/2018

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

491

NCT03351647
(ClinicalTrials.gov)

February 14, 2018

30/10/2017

Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease

Identification 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 Antibodies

Crohn Disease

Biological: Evaluation of biological predictive factors of clinical response to ustekinumab

Hospices Civils de Lyon

NULL

Unknown status

18 Years

All

France

492

EUCTR2017-003017-25-AT
(EUCTR)

06/02/2018

11/12/2017

Clinical 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 Disease

Provention Bio, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany

493

EUCTR2016-003123-32-IE
(EUCTR)

06/02/2018

25/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

494

EUCTR2016-003191-50-IE
(EUCTR)

06/02/2018

25/07/2017

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

495

EUCTR2016-003190-17-IE
(EUCTR)

06/02/2018

25/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

496

EUCTR2017-002258-36-BE
(EUCTR)

05/02/2018

02/10/2017

Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ALFASIGMA S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Spain;Belgium;Netherlands;Germany

497

NCT03395184
(ClinicalTrials.gov)

February 2, 2018

5/12/2017

Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE

Crohn's Disease

Drug: Placebo PF-06651600;Drug: Placebo PF-06700841;Drug: PF-06651600;Drug: PF-06700841

Pfizer

NULL

Recruiting

18 Years

75 Years

All

250

Phase 2

United 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

498

NCT03358706
(ClinicalTrials.gov)

February 2, 2018

27/11/2017

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.

Crohn Disease;Ulcerative Colitis

Drug: 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 mg

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

75 Years

All

Phase 1

United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark

499

EUCTR2016-003190-17-BE
(EUCTR)

01/02/2018

14/02/2018

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

500

NCT03059849
(ClinicalTrials.gov)

February 1, 2018

13/2/2017

Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

Crohn Disease;Ulcerative Colitis

Drug: Adalimumab

McMaster University

NULL

Withdrawn

18 Years

80 Years

All

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

501

EUCTR2016-003123-32-BE
(EUCTR)

01/02/2018

08/08/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

502

EUCTR2016-003191-50-BE
(EUCTR)

01/02/2018

14/02/2018

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

912

Phase 3

Belarus;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

503

NCT03185000
(ClinicalTrials.gov)

February 2018

13/4/2017

Treg Immunotherapy in Crohn's Disease

A Double-blind, Placebo Controlled, First Into Human Clinical Trial of T Regulatory Cells (TR004) for Inflammatory Bowel Disease Using (ex Vivo) Treg Expansion

Crohn Disease

Drug: TR004 (Treg immunotherapy);Other: Placebo

King's College London

Guy's and St Thomas' NHS Foundation Trust;Medical Research Council;Imperial College London;St. George's Hospital, London;Miltenyi biotech

Not yet recruiting

18 Years

80 Years

All

Phase 1;Phase 2

NULL

504

EUCTR2017-000574-11-LT
(EUCTR)

30/01/2018

31/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

505

EUCTR2017-000574-11-HU
(EUCTR)

23/01/2018

27/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Ulcerative colitis or Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

506

EUCTR2017-002231-41-PL
(EUCTR)

17/01/2018

13/10/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom

507

EUCTR2017-002182-21-PL
(EUCTR)

17/01/2018

13/10/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom

508

EUCTR2016-003190-17-GR
(EUCTR)

16/01/2018

15/11/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Belarus;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

509

EUCTR2016-003123-32-GR
(EUCTR)

16/01/2018

08/11/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

940

Phase 3

Belarus;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

510

EUCTR2016-003191-50-GR
(EUCTR)

16/01/2018

16/11/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

912

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

511

EUCTR2016-003191-50-NL
(EUCTR)

15/01/2018

08/08/2017

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

512

EUCTR2017-002231-41-BE
(EUCTR)

10/01/2018

14/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

513

EUCTR2017-002182-21-BE
(EUCTR)

10/01/2018

14/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

514

EUCTR2016-003123-32-DE
(EUCTR)

09/01/2018

19/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

515

EUCTR2016-003191-50-DE
(EUCTR)

09/01/2018

20/07/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

516

EUCTR2016-003190-17-DE
(EUCTR)

09/01/2018

19/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand

517

EUCTR2017-003017-25-HU
(EUCTR)

08/01/2018

13/11/2017

Clinical 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 Disease

Provention Bio, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany

518

EUCTR2017-000725-12-IT
(EUCTR)

08/01/2018

09/11/2020

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: [Cx601]

TIGENIX S.A.U

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

326

Phase 3

United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany

519

EUCTR2017-000574-11-BG
(EUCTR)

04/01/2018

24/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil

520

EUCTR2016-003190-17-LT
(EUCTR)

29/12/2017

17/10/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Serbia;Portugal;United States;Belarus;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

521

EUCTR2016-000522-18-NL
(EUCTR)

28/12/2017

03/07/2017

Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

PIBDNet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 4

France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom

522

EUCTR2017-000574-11-AT
(EUCTR)

22/12/2017

30/10/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

523

EUCTR2016-003179-23-DE
(EUCTR)

19/12/2017

14/02/2017

This 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)

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

524

NCT03104413
(ClinicalTrials.gov)

December 18, 2017

4/4/2017

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Crohn's Disease

Drug: placebo for risankizumab IV;Drug: risankizumab SC;Drug: risankizumab IV

AbbVie

NULL

Active, not recruiting

16 Years

80 Years

All

618

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey

525

EUCTR2017-002182-21-FR
(EUCTR)

18/12/2017

15/12/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

526

EUCTR2017-002231-41-DE
(EUCTR)

18/12/2017

14/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

527

EUCTR2017-002182-21-DE
(EUCTR)

18/12/2017

13/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

528

EUCTR2017-000574-11-SK
(EUCTR)

13/12/2017

21/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2453

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Germany;Netherlands

529

NCT03345849
(ClinicalTrials.gov)

December 7, 2017

15/11/2017

A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Crohn's Disease

Drug: Upadacitinib;Drug: Placebo for Upadacitinib

AbbVie

NULL

Recruiting

18 Years

75 Years

All

501

Phase 3

530

EUCTR2017-002258-36-ES
(EUCTR)

04/12/2017

03/10/2017

Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rifaximin delayed release 400 mg film coated tablet
Product Code: Rifaximin -EIR
INN or Proposed INN: RIFAXIMIN
Other descriptive name: RIFAXIMINA

ALFASIGMA S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Spain;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

531

NCT02974322
(ClinicalTrials.gov)

December 1, 2017

23/11/2016

A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

A 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 Disease

Crohn Disease

Drug: GED-0301;Drug: Placebo

Celgene

NULL

Withdrawn

12 Years

N/A

All

Phase 3

United 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

532

NCT03345836
(ClinicalTrials.gov)

November 29, 2017

15/11/2017

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Crohn's Disease

Other: Matching placebo for upadacitinib;Drug: upadacitinib

AbbVie

NULL

Recruiting

18 Years

75 Years

All

645

Phase 3

533

NCT02559713
(ClinicalTrials.gov)

November 29, 2017

23/9/2015

Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

An 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 Therapeutically

Colitis, Ulcerative;Crohn's Disease

Drug: Vedolizumab

Takeda

NULL

Completed

18 Years

N/A

Female

Phase 4

United States

534

EUCTR2016-003153-15-DE
(EUCTR)

28/11/2017

13/04/2017

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Czech Republic;Canada;Belgium;Spain;Poland;Austria;Germany;United Kingdom;Italy

535

EUCTR2016-003191-50-GB
(EUCTR)

28/11/2017

24/07/2017

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

536

EUCTR2016-003123-32-GB
(EUCTR)

28/11/2017

20/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

537

EUCTR2016-003190-17-GB
(EUCTR)

28/11/2017

20/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Belarus;Portugal;Hong Kong;Taiwan

538

NCT03362736
(ClinicalTrials.gov)

November 27, 2017

30/11/2017

An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease

An Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ustekinumab

Janssen Research & Development, LLC

NULL

No longer available

18 Years

N/A

All

Brazil

539

EUCTR2017-002258-36-DE
(EUCTR)

21/11/2017

01/08/2017

Post-operative endoscopic Crohn’s disease recurrence
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ALFASIGMA S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Spain;Belgium;Netherlands;Germany

540

EUCTR2017-000725-12-FR
(EUCTR)

16/11/2017

25/11/2019

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

326

Phase 3

United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

541

EUCTR2017-002182-21-GB
(EUCTR)

16/11/2017

11/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

542

EUCTR2017-002231-41-GB
(EUCTR)

15/11/2017

11/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

543

EUCTR2016-003190-17-EE
(EUCTR)

13/11/2017

30/08/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

544

EUCTR2016-003190-17-BG
(EUCTR)

08/11/2017

28/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

579

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand

545

EUCTR2016-003191-50-BG
(EUCTR)

08/11/2017

27/07/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

546

EUCTR2016-003123-32-BG
(EUCTR)

08/11/2017

28/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

855

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

547

EUCTR2016-003190-17-NL
(EUCTR)

07/11/2017

10/08/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Serbia;Portugal;United States;Belarus;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

548

EUCTR2016-002763-34-NL
(EUCTR)

06/11/2017

14/08/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden

549

EUCTR2016-001367-36-NL
(EUCTR)

06/11/2017

14/08/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

550

EUCTR2017-002545-30-GB
(EUCTR)

06/11/2017

07/06/2018

Controlled trial to assess low intensity autologous stem cell transplant in refractory Crohn's Disease

Autologous Stem cell Transplantation In refractory Crohn's disease - Low Intensity Therapy Evaluation - ASTIClite

Refractory Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Trade Name: Filgrastim
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Fludarabine
Product Name: Fludarabine
INN or Proposed INN: Fludarabine phosphate
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin

Barts Health NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

551

NCT03357471
(ClinicalTrials.gov)

November 3, 2017

23/11/2017

Study 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 Disease

A 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 Disease

Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease

Drug: e-Device

UCB Biopharma S.P.R.L.

NULL

Completed

18 Years

N/A

All

Phase 3

United States

552

NCT03167437
(ClinicalTrials.gov)

October 30, 2017

24/5/2017

Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn s Disease

An Open-Label, Phase I/II Pilot Study to Assess the Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn s Disease

Crohn's Disease

Drug: Vorinostat

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Recruiting

18 Years

65 Years

All

Phase 1;Phase 2

United States

553

EUCTR2016-003123-32-ES
(EUCTR)

25/10/2017

20/10/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

940

Phase 3

Belarus;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

554

EUCTR2017-002231-41-HU
(EUCTR)

25/10/2017

19/09/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

555

EUCTR2016-003191-50-ES
(EUCTR)

25/10/2017

20/10/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

912

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

556

EUCTR2017-002182-21-HU
(EUCTR)

25/10/2017

12/09/2017

An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom

Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

557

NCT03495973
(ClinicalTrials.gov)

October 25, 2017

28/3/2018

Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease

Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)

Crohn Disease

Drug: Ustekinumab

Janssen-Cilag Ltd.

NULL

Active, not recruiting

18 Years

N/A

All

110

Sweden

558

EUCTR2016-003190-17-ES
(EUCTR)

25/10/2017

20/10/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Belarus;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

559

NCT03220243
(ClinicalTrials.gov)

October 19, 2017

14/7/2017

Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Rectovaginal Fistulizing Crohn's Disease

Fistula Vagina;Crohn Disease

Drug: MSC-AFP

Mayo Clinic

NULL

Completed

18 Years

65 Years

Female

Phase 1

United States

560

EUCTR2015-001924-40-HR
(EUCTR)

13/10/2017

02/11/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease

Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

561

EUCTR2014-005376-29-HU
(EUCTR)

13/10/2017

30/08/2017

An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of Crohn's disease versus subject with longer exisiting Crohn's disease

An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio

Academic Medical Center, Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 4

Hungary;Belgium;Netherlands

562

EUCTR2016-003123-32-EE
(EUCTR)

10/10/2017

28/08/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

563

EUCTR2016-003191-50-EE
(EUCTR)

10/10/2017

10/08/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

959

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

564

NCT03194529
(ClinicalTrials.gov)

October 9, 2017

19/6/2017

FMT in Pediatric Crohn's Disease

Safety of FMT in Maintenance of Pediatric Crohn's Disease

Crohn Disease;Pediatric Crohns Disease

Biological: FMT

Children's Hospital Los Angeles

NULL

Completed

7 Years

21 Years

All

Phase 1;Phase 2

United States

565

EUCTR2016-002918-43-PT
(EUCTR)

09/10/2017

11/08/2017

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

France;Portugal;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

566

EUCTR2016-003190-17-CZ
(EUCTR)

02/10/2017

19/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand

567

EUCTR2016-003123-32-SK
(EUCTR)

15/09/2017

23/05/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

940

Phase 3

568

NCT03279081
(ClinicalTrials.gov)

September 15, 2017

21/7/2017

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 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 Weeks

Crohn's Disease

Drug: Cx601;Other: Placebo

Tigenix S.A.U.

NULL

Recruiting

18 Years

N/A

All

554

Phase 3

United States;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;United Kingdom

569

EUCTR2016-003191-50-CZ
(EUCTR)

13/09/2017

21/07/2017

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

570

EUCTR2017-000725-12-BE
(EUCTR)

12/09/2017

01/06/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Israel;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

571

EUCTR2017-000725-12-HU
(EUCTR)

07/09/2017

10/07/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy

572

EUCTR2017-000725-12-PL
(EUCTR)

03/09/2017

28/07/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Belgium;Poland;Israel;Germany;United Kingdom;Italy

573

JPRN-JapicCTI-184152

01/9/2017

11/10/2018

Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease

Crohn's disease

Intervention name : Budesonide ( Zentacort Capsules 3mg )
INN of the intervention : Budesonide
Dosage And administration of the intervention : Oral

ZERIA Pharmaceutical Co., Ltd.

NULL

recruiting

BOTH

200

NULL

574

NCT02872506
(ClinicalTrials.gov)

September 2017

16/8/2016

Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection

Quality of Life

Drug: Anti TNF;Procedure: ileocecal resection

University Hospital, Lille

NULL

Withdrawn

18 Years

N/A

All

N/A

NULL

575

EUCTR2016-003191-50-PT
(EUCTR)

28/08/2017

21/07/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

576

EUCTR2016-003123-32-PT
(EUCTR)

28/08/2017

21/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

577

EUCTR2016-003190-17-PT
(EUCTR)

28/08/2017

21/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand

578

EUCTR2016-003190-17-AT
(EUCTR)

25/08/2017

31/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

579

EUCTR2016-003123-32-AT
(EUCTR)

25/08/2017

31/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

855

Phase 3

Norway;Japan;New Zealand;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany

580

EUCTR2016-003191-50-SK
(EUCTR)

23/08/2017

31/05/2017

A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

581

ChiCTR-INR-17012532

2017-08-23

2017-09-01

The use of indocyanine green fluorescent angiography to guide the surgical treatment of Crohn's disease

The use of indocyanine green fluorescent angiography to guide the surgical treatment of Crohn's disease: a single-center randomized single-blind cohort study

Crohn's disease

Intervention group:Indocyanine green fluorescent angiography;control group:Physiological saline;

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

NULL

Recruiting

Both

Intervention group:40;control group:40;

China

582

EUCTR2016-003190-17-SK
(EUCTR)

23/08/2017

24/05/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

583

EUCTR2016-003153-15-CZ
(EUCTR)

21/08/2017

13/04/2017

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Perianal Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Austria;Germany;Italy;United Kingdom

584

EUCTR2016-003191-50-LV
(EUCTR)

18/08/2017

25/07/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

959

Phase 3

Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

585

EUCTR2017-000725-12-CZ
(EUCTR)

08/08/2017

26/04/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

554

Phase 3

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

586

NCT03234907
(ClinicalTrials.gov)

August 3, 2017

26/7/2017

Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: Vedolizumab IV;Drug: Placebo

Takeda

NULL

Completed

18 Years

80 Years

All

215

Phase 3

China

587

EUCTR2016-003191-50-AT
(EUCTR)

03/08/2017

31/07/2017

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

588

EUCTR2016-003153-15-GB
(EUCTR)

01/08/2017

10/04/2017

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Czechia;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany

589

NCT03162432
(ClinicalTrials.gov)

August 1, 2017

15/5/2017

High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade

IBD;Ulcerative Colitis;Crohn Disease

Drug: Vitamin D3

Boston Children's Hospital

NULL

Completed

7 Years

25 Years

All

Phase 3

United States

590

EUCTR2015-000852-12-BE
(EUCTR)

31/07/2017

24/03/2016

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE

Fistulizing Crohn’s Disease (CD)
MedDRA version: 18.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
INN or Proposed INN: vedolizumab

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 4

France;United States;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

591

EUCTR2016-003190-17-LV
(EUCTR)

31/07/2017

01/08/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

Belarus;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

592

EUCTR2016-003123-32-LV
(EUCTR)

31/07/2017

01/08/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

940

Phase 3

Belarus;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

593

EUCTR2017-000725-12-ES
(EUCTR)

26/07/2017

06/06/2017

A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).

Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue
Product Code: Cx601
INN or Proposed INN: To be determined
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

326

Phase 3

United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy

594

EUCTR2016-003190-17-DK
(EUCTR)

25/07/2017

19/07/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

579

Phase 3

595

EUCTR2016-003191-50-DK
(EUCTR)

19/07/2017

18/07/2017

A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

596

NCT02330211
(ClinicalTrials.gov)

July 17, 2017

29/12/2014

Fecal Microbiota Transplant (FMT) in Pediatric Active Crohn's Colitis

A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Crohn's Colitis

Inflammatory Bowel Diseases;Crohn Disease

Biological: Fecal Microbiota Transplant;Biological: Placebo

Stacy A. Kahn

NULL

Completed

5 Years

30 Years

All

Phase 1;Phase 2

United States

597

EUCTR2016-003153-15-IT
(EUCTR)

17/07/2017

20/11/2020

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn¿s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn¿s Disease - This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as

Perianal Fistulizing Crohn¿s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

GILEAD SCIENCES INCORPORATED

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany

598

EUCTR2015-000609-38-GB
(EUCTR)

17/07/2017

10/05/2018

A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy

A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

Allergan Limited

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

599

NCT03169894
(ClinicalTrials.gov)

July 14, 2017

24/5/2017

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease

Phase 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 Disease

Drug: MDGN-002

Aevi Genomic Medicine, LLC, a Cerecor company

NULL

Recruiting

18 Years

65 Years

All

Phase 1

United States

600

NCT03219359
(ClinicalTrials.gov)

July 12, 2017

13/7/2017

Autologous Stem Cell Transplant for Crohn's Disease

Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD)

Crohn Disease

Procedure: Autologous stem cell transplant;Drug: Cyclophosphamide;Drug: Thymoglobulin;Drug: Methylprednisolone;Drug: Vedolizumab

Icahn School of Medicine at Mount Sinai

NULL

Recruiting

18 Years

N/A

All

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

601

EUCTR2016-001956-22-DE
(EUCTR)

04/07/2017

28/10/2016

A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease

A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

France;United States;Canada;Poland;Belgium;Germany

602

JPRN-UMIN000028139

2017/07/04

07/07/2017

Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease

Crohn's disease

Treatment with Ustekinumab

Graduate School of Medical Sciences, Kyushu University

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

603

EUCTR2016-002918-43-DE
(EUCTR)

03/07/2017

13/02/2017

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden

604

NCT03014219
(ClinicalTrials.gov)

July 2017

4/1/2017

Phase 1 Crohn's Pediatric Sub-study of MSC AFP

A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study

Perianal Fistula

Drug: Only 1 arm: treatment with MSC-AFP

William A. Faubion, M.D.

NULL

Withdrawn

12 Years

17 Years

All

Phase 1

United States

605

EUCTR2016-002763-34-HR
(EUCTR)

26/06/2017

12/09/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

606

EUCTR2016-001367-36-HR
(EUCTR)

26/06/2017

12/09/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

Serbia;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

607

EUCTR2015-001924-40-PT
(EUCTR)

26/06/2017

01/03/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden

608

JPRN-jRCTs041180126

17/06/2017

23/03/2019

CD Alfacalcidol study

The study of effect of Alfacalcidol treatment on Crohn's disease

Crohn's disease

administration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level.

Nakamura Masanao

NULL

Recruiting

>= 18age old

Not applicable

Both

Phase 2

Japan

609

NCT03267238
(ClinicalTrials.gov)

June 16, 2017

24/7/2017

Fecal Microbial Transplantation in Patients With Crohn's Disease

Crohn Disease

Biological: Fecal Microbial Transplantation

Stony Brook University

NULL

Active, not recruiting

7 Years

N/A

All

Early Phase 1

United States

610

NCT03235180
(ClinicalTrials.gov)

June 16, 2017

27/7/2017

Ultrasound Evaluation of Crohn's Disease

Crohn Disease

Drug: Sulfur Hexafluoride;Device: Ultrasound Elastography;Device: Ultrasound Vascularity;Device: Magnetic Resonance Enterography (MRE)

Mayo Clinic

NULL

Enrolling by invitation

18 Years

N/A

All

100

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

611

EUCTR2015-001924-40-BE
(EUCTR)

14/06/2017

06/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Netherlands;Latvia;Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark

612

EUCTR2016-002918-43-NL
(EUCTR)

14/06/2017

02/03/2017

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;France;Belgium;Spain;Germany;Netherlands;Italy;United Kingdom;Sweden

613

NCT02764762
(ClinicalTrials.gov)

June 12, 2017

5/5/2016

Triple 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 Complications

Crohn Disease

Drug: Vedolizumab;Drug: Adalimumab;Drug: Methotrexate

Takeda

NULL

Active, not recruiting

18 Years

65 Years

All

Phase 4

United States;Canada

614

EUCTR2015-001924-40-IT
(EUCTR)

12/06/2017

23/02/2018

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Other descriptive name: GED-0301
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Other descriptive name: GED-0301

CELGENE CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden

615

EUCTR2016-003153-15-HU
(EUCTR)

08/06/2017

13/04/2017

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Perianal Fistulizing Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

616

EUCTR2016-003153-15-PL
(EUCTR)

07/06/2017

19/04/2017

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy;United Kingdom

617

NCT03393247
(ClinicalTrials.gov)

June 1, 2017

8/7/2017

The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study

Crohn Disease

Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14

Sixth Affiliated Hospital, Sun Yat-sen University

NULL

Unknown status

14 Years

60 Years

All

160

N/A

China

618

EUCTR2015-003759-23-CZ
(EUCTR)

01/06/2017

30/06/2016

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

619

EUCTR2016-001367-36-NO
(EUCTR)

31/05/2017

09/11/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

620

EUCTR2016-002763-34-SE
(EUCTR)

24/05/2017

27/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

621

EUCTR2016-001367-36-SE
(EUCTR)

24/05/2017

27/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

622

JPRN-UMIN000025961

2017/05/21

01/03/2017

The study of effect of Alfacalcidol treatment on Crohn's disease

The study of effect of Alfacalcidol treatment on Crohn's disease - The study of effect of Alfacalcidol treatment on Crohn's disease

Crohn's disease

Oral treatment of Alfacalcidol 1 microgram/day for 3 month

Nagoya University Hospital

NULL

Recruiting

18years-old

Not applicable

Male and Female

Not selected

Japan

623

NCT03155945
(ClinicalTrials.gov)

May 18, 2017

11/5/2017

Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain

A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain

Crohn's Disease;Abdominal Pain

Drug: APD371

Arena Pharmaceuticals

NULL

Completed

18 Years

80 Years

All

Phase 2

United States

624

EUCTR2015-001924-40-GB
(EUCTR)

17/05/2017

27/01/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

625

NCT03105128
(ClinicalTrials.gov)

May 10, 2017

4/4/2017

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SC

AbbVie

NULL

Active, not recruiting

16 Years

80 Years

All

931

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Finland;France;Hungary;Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

626

EUCTR2016-000612-14-HR
(EUCTR)

10/05/2017

07/06/2017

BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity

Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3

United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina

627

EUCTR2016-001367-36-IS
(EUCTR)

09/05/2017

27/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of

628

EUCTR2016-002763-34-IS
(EUCTR)

09/05/2017

27/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

629

EUCTR2015-001924-40-GR
(EUCTR)

05/05/2017

20/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

630

EUCTR2016-002763-34-GR
(EUCTR)

05/05/2017

03/01/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

631

EUCTR2016-003153-15-ES
(EUCTR)

03/05/2017

04/05/2017

This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Israel;Germany;Italy;United Kingdom

632

EUCTR2016-002204-84-BE
(EUCTR)

02/05/2017

06/02/2017

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Product Name: LY3074828
INN or Proposed INN: Not assigned
Other descriptive name: LY3074828

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Netherlands;Japan;Moldova, Republic of

633

EUCTR2016-003179-23-PL
(EUCTR)

27/04/2017

01/03/2017

This 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)

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Germany

634

EUCTR2016-002204-84-PL
(EUCTR)

27/04/2017

20/01/2017

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of

635

EUCTR2016-003179-23-HU
(EUCTR)

26/04/2017

06/03/2017

This 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)

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

636

EUCTR2016-002204-84-NL
(EUCTR)

25/04/2017

08/12/2016

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of

637

EUCTR2015-001924-40-NL
(EUCTR)

24/04/2017

08/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden

638

NCT02994836
(ClinicalTrials.gov)

April 21, 2017

24/10/2016

GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )

Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation

Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis

Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus)

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

194

Phase 4

Spain

639

EUCTR2015-001924-40-FR
(EUCTR)

20/04/2017

27/03/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

640

NCT03107793
(ClinicalTrials.gov)

April 19, 2017

28/3/2017

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

Crohn Disease

Drug: Ustekinumab

Janssen-Cilag Ltd.

NULL

Active, not recruiting

18 Years

N/A

All

500

Phase 3

Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Portugal;Slovakia;Spain;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

641

EUCTR2016-002939-15-NL
(EUCTR)

18/04/2017

22/02/2017

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study).

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Netherlands;Germany;Norway

642

NCT03108326
(ClinicalTrials.gov)

April 15, 2017

30/3/2017

Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease

Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome

Crohn Disease

Biological: Stelara , Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra

Ced Service GmbH

NULL

Recruiting

18 Years

80 Years

All

900

Germany

643

EUCTR2016-003179-23-GB
(EUCTR)

13/04/2017

09/02/2017

This 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)

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

644

EUCTR2015-001924-40-DE
(EUCTR)

12/04/2017

06/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

645

EUCTR2015-001924-40-HU
(EUCTR)

07/04/2017

09/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

646

EUCTR2015-003759-23-HU
(EUCTR)

07/04/2017

28/02/2017

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease

Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

647

EUCTR2015-001924-40-ES
(EUCTR)

07/04/2017

10/03/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

648

EUCTR2016-003179-23-CZ
(EUCTR)

06/04/2017

15/02/2017

This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)

Small Bowel Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

649

EUCTR2016-002939-15-DE
(EUCTR)

05/04/2017

02/11/2016

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway

650

EUCTR2016-003179-23-FR
(EUCTR)

04/04/2017

This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)

Small Bowel Crohn’s Disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Italy;United States;Spain;Ukraine;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

651

EUCTR2015-001924-40-DK
(EUCTR)

04/04/2017

07/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

652

EUCTR2016-002918-43-BE
(EUCTR)

03/04/2017

02/02/2017

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;France;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden

653

EUCTR2015-001924-40-LV
(EUCTR)

31/03/2017

02/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

654

EUCTR2016-001367-36-GR
(EUCTR)

31/03/2017

03/01/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

655

EUCTR2016-002763-34-BE
(EUCTR)

31/03/2017

08/08/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

656

EUCTR2016-001367-36-BE
(EUCTR)

31/03/2017

08/08/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden

657

EUCTR2016-000612-14-GR
(EUCTR)

31/03/2017

02/02/2017

BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Moderately to severely active Crohn’s disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

286

Phase 3

United States;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina

658

EUCTR2015-001963-37-FI
(EUCTR)

30/03/2017

23/02/2017

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

659

EUCTR2015-001924-40-FI
(EUCTR)

30/03/2017

28/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

660

EUCTR2016-002939-15-HU
(EUCTR)

29/03/2017

06/01/2017

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Germany;Netherlands;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

661

NCT03090139
(ClinicalTrials.gov)

March 28, 2017

22/3/2017

Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets

Indicators 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 Diseases

Drug: Anti-TNF Therapy

Takeda

NULL

Completed

18 Years

N/A

All

1731

Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey

662

EUCTR2016-002763-34-DE
(EUCTR)

27/03/2017

27/01/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Slovakia;India;Serbia;France

663

EUCTR2016-001367-36-DE
(EUCTR)

27/03/2017

27/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

664

EUCTR2016-002763-34-BG
(EUCTR)

23/03/2017

12/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

665

EUCTR2016-001367-36-BG
(EUCTR)

23/03/2017

12/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

666

EUCTR2016-002204-84-AT
(EUCTR)

22/03/2017

11/11/2016

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Product Name: LY3074828
INN or Proposed INN: LY3074828
Other descriptive name: LY3074828

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of

667

EUCTR2015-001924-40-CZ
(EUCTR)

21/03/2017

01/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden

668

NCT03009396
(ClinicalTrials.gov)

March 18, 2017

26/12/2016

Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study

Crohn Disease

Drug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine

RedHill Biopharma Limited

NULL

Completed

18 Years

76 Years

All

Phase 3

United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia

669

EUCTR2015-001924-40-SK
(EUCTR)

16/03/2017

03/02/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden

670

NCT03027193
(ClinicalTrials.gov)

March 15, 2017

19/1/2017

A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers

A 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 Volunteers

Crohn Disease;Mycobacterium Avium Subspecies Paratuberculosis

Biological: ChAdOx2 HAV;Biological: MVA HAV

University of Oxford

NULL

Completed

18 Years

50 Years

All

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

671

EUCTR2016-002918-43-SE
(EUCTR)

15/03/2017

19/01/2017

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden

672

EUCTR2015-001179-36-BG
(EUCTR)

14/03/2017

17/01/2017

Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.

A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

324

Phase 3

Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand

673

EUCTR2016-001367-36-PT
(EUCTR)

13/03/2017

05/01/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

Norway;United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Iceland;New Zealand;Japan;Sweden

674

EUCTR2016-002763-34-PT
(EUCTR)

13/03/2017

05/01/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;United States;Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

675

EUCTR2016-002939-15-NO
(EUCTR)

09/03/2017

20/03/2019

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Norway;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

676

EUCTR2016-000786-24-IT
(EUCTR)

07/03/2017

30/11/2016

Efficacy and safety of thalidomide in pediatric patients with Crohn's disease

Thalidomide, a novel immunological treatment to modify the natural history of paediatric Crohn's disease: a new proposal from a well-established paediatric research network - Talidomide in Crohn disease in Pediatrics

Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

IRCCS Burlo Garofolo

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

124

Phase 3

Italy

677

EUCTR2016-002918-43-GB
(EUCTR)

28/02/2017

10/01/2017

Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Phase 3

Portugal;Belgium;Spain;Netherlands;Germany;United Kingdom

678

JPRN-UMIN000026330

2017/02/27

28/02/2017

Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease

Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients

Crohn disease

Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)

University of Toyama

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

Not selected

Japan

679

EUCTR2016-003797-40-BE
(EUCTR)

23/02/2017

28/10/2016

A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions

A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations

Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Belgium;Germany

680

EUCTR2015-001924-40-AT
(EUCTR)

21/02/2017

18/01/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

681

EUCTR2016-003179-23-ES
(EUCTR)

21/02/2017

20/02/2017

This 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)

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Israel;Germany;Italy;United Kingdom

682

EUCTR2016-003797-40-DE
(EUCTR)

21/02/2017

09/11/2016

A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions

A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations

Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: APD334
INN or Proposed INN: Not yet available
Other descriptive name: APD334

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Belgium;Germany

683

EUCTR2016-002763-34-SK
(EUCTR)

16/02/2017

12/01/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

684

EUCTR2016-001367-36-SK
(EUCTR)

16/02/2017

12/01/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

685

EUCTR2016-002939-15-SK
(EUCTR)

16/02/2017

12/01/2017

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

686

EUCTR2016-002763-34-HU
(EUCTR)

08/02/2017

08/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

687

EUCTR2016-001367-36-CZ
(EUCTR)

08/02/2017

16/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

688

EUCTR2016-001367-36-HU
(EUCTR)

08/02/2017

08/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease (CD)
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

689

EUCTR2016-002763-34-CZ
(EUCTR)

08/02/2017

16/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

690

EUCTR2016-002939-15-AT
(EUCTR)

07/02/2017

05/01/2017

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Germany;Netherlands;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

691

EUCTR2016-002204-84-CZ
(EUCTR)

02/02/2017

13/10/2016

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of

692

JPRN-jRCTs031180415

01/02/2017

22/03/2019

A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease

Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease

Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)

AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults).
FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
A-FMT arm : Patient undergoes FMT two days after AFM therapy.

Ishikawa Dai

NULL

Recruiting

>= 6age old

Not applicable

Both

120

N/A

Japan

693

EUCTR2016-002204-84-GB
(EUCTR)

01/02/2017

30/09/2016

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of

694

JPRN-UMIN000025846

2017/02/01

01/02/2017

A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease

ulcerative colitis, Crohn's disease

Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks

Juntendo university school of medicineDepartment of gastroenterology

NULL

Recruiting

16years-old

Not applicable

Male and Female

Not selected

Japan

695

NCT03755583
(ClinicalTrials.gov)

February 1, 2017

18/11/2018

Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease

Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease

Crohn Disease;Enteral Nutrition;Gastrointestinal Microbiome

Dietary Supplement: Exclusive Enteral Nutrition

Children's Hospital of Fudan University

NULL

Completed

1 Year

17 Years

All

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

696

EUCTR2016-001367-36-ES
(EUCTR)

31/01/2017

01/02/2017

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

697

EUCTR2016-002763-34-ES
(EUCTR)

31/01/2017

30/01/2017

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Moderately to Severely Active Crohn's Disease (CD)
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

698

EUCTR2016-001367-36-AT
(EUCTR)

31/01/2017

15/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

699

EUCTR2016-002763-34-AT
(EUCTR)

31/01/2017

15/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

700

EUCTR2015-001179-36-CZ
(EUCTR)

30/01/2017

15/11/2016

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

324

Phase 3

Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

701

EUCTR2016-000612-14-GB
(EUCTR)

25/01/2017

29/09/2016

BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

286

Phase 3

Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina

702

EUCTR2015-001925-18-FI
(EUCTR)

25/01/2017

22/12/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

Serbia;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

703

EUCTR2016-001956-22-BE
(EUCTR)

25/01/2017

26/10/2016

A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease

A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Moderately to severely active Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

France;United States;Canada;Poland;Belgium;Germany

704

EUCTR2016-002939-15-CZ
(EUCTR)

24/01/2017

01/11/2016

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease.

A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - English A six week efficacy, safety and tolerability study of V565 in Crohn’s disease (HarbOR study)

Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway

705

NCT04272788
(ClinicalTrials.gov)

January 24, 2017

11/2/2020

Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease

Crohn Disease

Drug: Infliximab

Second Affiliated Hospital of Wenzhou Medical University

NULL

Completed

18 Years

N/A

All

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

706

EUCTR2016-002939-15-GB
(EUCTR)

19/01/2017

24/07/2020

A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: V565
Product Code: V565
INN or Proposed INN: not applied for
Other descriptive name: V565

VHsquared Ltd

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 2

United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway

707

EUCTR2016-002204-84-HU
(EUCTR)

19/01/2017

09/11/2016

A Crohn's Disease study

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of

708

EUCTR2016-003321-42-NL
(EUCTR)

18/01/2017

08/12/2016

Stepwise extention of the adalimumab injection interval in patients with stable Crohn's disease.

Lengthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients: the LADI study.

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira (adalimumab)
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Radboud University Medical Centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

709

EUCTR2016-000612-14-DE
(EUCTR)

18/01/2017

05/09/2016

BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

130

Phase 3

United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina

710

NCT02968108
(ClinicalTrials.gov)

January 18, 2017

24/10/2016

A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

A Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ustekinumab

Janssen Research & Development, LLC

NULL

Active, not recruiting

2 Years

17 Years

All

Phase 1

United States;Belgium;Canada;France;Germany;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

711

EUCTR2016-000634-21-PL
(EUCTR)

13/01/2017

11/10/2016

A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500 -AAA
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

654

Phase 2

France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of;United States;Ukraine;Russian Federation;United Kingdom;Italy

712

EUCTR2015-001179-36-SK
(EUCTR)

13/01/2017

21/11/2016

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

324

Phase 3

Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand

713

EUCTR2016-001956-22-PL
(EUCTR)

12/01/2017

01/12/2016

A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease

A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

United States;France;Canada;Belgium;Poland;Germany

714

EUCTR2016-000522-18-DE
(EUCTR)

05/01/2017

01/08/2016

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Product Name: Methotrexat
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

PIBD-Net

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 3

France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom

715

EUCTR2016-000678-40-BG
(EUCTR)

05/01/2017

01/11/2016

Program 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 treatment

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Not Recruiting

Female: yes
Male: yes

385

Phase 4

Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

716

EUCTR2016-002763-34-GB
(EUCTR)

04/01/2017

21/12/2016

A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden

717

EUCTR2016-001367-36-GB
(EUCTR)

04/01/2017

19/12/2016

A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1320

Phase 3

718

NCT02862132
(ClinicalTrials.gov)

January 2017

31/7/2016

Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

Predicting 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 Disease

Drug: Vedolizumab

Shaare Zedek Medical Center

NULL

Recruiting

N/A

18 Years

All

120

N/A

United States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom

719

NCT03056664
(ClinicalTrials.gov)

January 2017

24/8/2015

The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease

The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease

Crohn's Disease;Fistula

Procedure: Routine drainage surgery;Biological: MSC injection 01;Biological: MSC injection 02;Other: placebo

Sixth Affiliated Hospital, Sun Yat-sen University

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 2;Phase 3

NULL

720

NCT03012542
(ClinicalTrials.gov)

January 2017

4/1/2017

Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease

Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome

Crohn Disease

Dietary Supplement: Diet 1;Dietary Supplement: Diet 2

University of Washington

NULL

Unknown status

18 Years

N/A

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

721

EUCTR2015-000555-24-FR
(EUCTR)

28/12/2016

03/01/2017

Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.

Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Academic Medical Center Amsterdam

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France;Spain;Netherlands

722

EUCTR2015-003759-23-DE
(EUCTR)

16/12/2016

25/05/2016

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT 494) in Subjects with Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;New Zealand

723

NCT02891226
(ClinicalTrials.gov)

December 14, 2016

1/9/2016

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)

Crohn's Disease

Drug: Mirikizumab;Drug: Placebo

Eli Lilly and Company

NULL

Active, not recruiting

18 Years

75 Years

All

180

Phase 2

United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France

724

EUCTR2016-000612-14-CZ
(EUCTR)

14/12/2016

24/10/2016

BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 3

United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina

725

NCT02231814
(ClinicalTrials.gov)

December 2016

27/8/2014

Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease

Dietary 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 Study

Crohn's Disease

Dietary Supplement: Crohns Disease Exclusion Diet + PEN;Other: Crohns Disease Exclusion Diet

Prof. Arie Levine

NULL

Recruiting

18 Years

55 Years

All

N/A

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

726

NCT02976129
(ClinicalTrials.gov)

December 2016

23/11/2016

A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease

Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease

Crohn's Disease

Drug: V565;Drug: Placebo

VHsquared Ltd.

NULL

Unknown status

18 Years

80 Years

All

126

Phase 2

United States;Austria;Canada;Czechia;Germany;Hungary;Netherlands;Norway;Poland;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic

727

EUCTR2015-003759-23-GB
(EUCTR)

24/11/2016

24/05/2016

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand

728

NCT03183661
(ClinicalTrials.gov)

November 16, 2016

8/6/2017

A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial

Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)

Crohn Disease

Biological: ALLO-ASC-CD

Anterogen Co., Ltd.

NULL

Enrolling by invitation

18 Years

65 Years

All

N/A

NULL

729

EUCTR2016-000634-21-HU
(EUCTR)

11/11/2016

12/09/2016

A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

693

Phase 2

United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of

730

EUCTR2016-000634-21-GB
(EUCTR)

11/11/2016

03/08/2016

A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

654

Phase 2

United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

731

EUCTR2016-000634-21-DE
(EUCTR)

08/11/2016

07/07/2016

A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: JNJ-64304500
INN or Proposed INN: JNJ-64304500
Other descriptive name: JNJ-64304500 -AAA
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 2

United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of

732

EUCTR2015-003759-23-DK
(EUCTR)

04/11/2016

24/05/2016

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;New Zealand

733

EUCTR2015-003759-23-NL
(EUCTR)

03/11/2016

06/06/2016

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand

734

JPRN-UMIN000024566

2016/11/01

01/11/2016

Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.

Crohn'disease

Dose 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 Hospital

NULL

Pending

16years-old

Not applicable

Male and Female

Not applicable

Japan

735

NCT02760615
(ClinicalTrials.gov)

November 1, 2016

2/5/2016

Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

An 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 Disease

Colitis, Ulcerative;Crohn Disease

Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab

Takeda

NULL

Withdrawn

18 Years

55 Years

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

736

NCT02998827
(ClinicalTrials.gov)

November 2016

24/11/2016

Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients

Crohn Disease

Drug: Thalidomide;Drug: infliximab , azathioprine;Other: enteral nutrition

Sixth Affiliated Hospital, Sun Yat-sen University

NULL

Enrolling by invitation

N/A

Female

N/A

NULL

737

JPRN-UMIN000023735

2016/10/31

31/10/2016

Does 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

Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study - TRADE study

Crohn's disease

EW or EOW injection of adalimumab

Saitama Medical Center, Saitama Medical University

NULL

Complete: follow-up complete

15years-old

75years-old

Male and Female

Not selected

Japan

738

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)

Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

739

EUCTR2015-003759-23-BE
(EUCTR)

11/10/2016

14/07/2016

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

740

EUCTR2015-000852-12-NL
(EUCTR)

05/10/2016

30/05/2016

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Fistulizing Crohn’s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 4

France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

741

NCT02956538
(ClinicalTrials.gov)

October 2016

13/10/2016

Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide

Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study

Crohn Disease

Drug: Thalidomide;Drug: placebo(for thalidomide)

Sixth Affiliated Hospital, Sun Yat-sen University

NULL

Recruiting

18 Years

50 Years

Both

Phase 0

China

742

NCT02883452
(ClinicalTrials.gov)

September 29, 2016

25/8/2016

A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis

An 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 Colitis

Crohn's Disease;Ulcerative Colitis (Part 2 Only)

Biological: CT-P13

Celltrion

NULL

Completed

18 Years

75 Years

All

181

Phase 1

Korea, Republic of

743

EUCTR2016-003073-18-GB
(EUCTR)

29/09/2016

16/09/2016

A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body

A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)

The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Celgene International II Sàrl

NULL

Not Recruiting

Female: no
Male: yes

Phase 1

United Kingdom

744

EUCTR2015-001963-37-GR
(EUCTR)

28/09/2016

01/06/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Active Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

745

NCT02871635
(ClinicalTrials.gov)

September 28, 2016

15/8/2016

BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

Crohn Disease

Drug: BI 695501;Drug: HUMIRA

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

All

147

Phase 3

United States;Belarus;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Israel;Poland;Russian Federation;Serbia;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

746

EUCTR2014-004904-31-BE
(EUCTR)

21/09/2016

29/07/2016

A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 4

Belgium;Netherlands

747

EUCTR2015-003759-23-ES
(EUCTR)

19/09/2016

11/08/2016

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease

Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Puerto Rico;Canada;Spain;Australia;Israel;New Zealand

748

EUCTR2015-003759-23-SK
(EUCTR)

05/09/2016

23/06/2016

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;New Zealand

749

NCT02820493
(ClinicalTrials.gov)

September 2016

17/5/2016

Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression

Crohn Disease

Drug: vedolizumab

Universita degli Studi di Genova

NULL

Withdrawn

18 Years

80 Years

All

Phase 4

NULL

750

JPRN-UMIN000023871

2016/08/25

01/09/2016

Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)

Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) - Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)

Crohn's disease

Administration of Adalimumab 80 mg every 2 weeks.
Administration of Adalimumab 40 mg every week.

Fukuoka University Chikushi Hospital

NULL

Complete: follow-up complete

16years-old

Not applicable

Male and Female

100

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

751

NCT02877134
(ClinicalTrials.gov)

August 25, 2016

19/8/2016

Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: JNJ-64304500;Drug: Placebo;Drug: Ustekinumab

Janssen Research & Development, LLC

NULL

Active, not recruiting

18 Years

N/A

All

390

Phase 2

United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Czechia;Italy;Serbia

752

EUCTR2016-000678-40-EE
(EUCTR)

22/08/2016

20/06/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

753

EUCTR2016-000678-40-LV
(EUCTR)

19/08/2016

10/05/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

754

EUCTR2015-000555-24-ES
(EUCTR)

11/08/2016

15/07/2016

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Academic Medical Center Amsterdam

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Spain;Netherlands

755

NCT02630966
(ClinicalTrials.gov)

August 10, 2016

11/12/2015

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Crohn's Disease

Drug: Vedolizumab;Drug: Placebo

Takeda

NULL

Completed

18 Years

80 Years

All

Phase 4

United States;Canada;France;Italy;Netherlands;Spain;United Kingdom;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

756

NCT02743806
(ClinicalTrials.gov)

August 1, 2016

15/4/2016

Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease

Colitis, Ulcerative;Crohn Disease

Drug: Vedolizumab

Takeda

NULL

Active, not recruiting

18 Years

90 Years

All

331

Phase 4

Australia;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

757

NCT02897661
(ClinicalTrials.gov)

August 2016

14/8/2016

Washed Microbiota Transplantation Improves Nutritional Status of Patients With Crohn's Disease

Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease

Crohn's Diseases

Procedure: WMT;Dietary Supplement: EEN

The Second Hospital of Nanjing Medical University

NULL

Recruiting

18 Years

65 Years

All

N/A

China

758

NCT02641392
(ClinicalTrials.gov)

July 25, 2016

23/12/2015

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Crohn's Disease

Drug: GED-0301;Other: Placebo

Celgene

NULL

Terminated

12 Years

N/A

All

310

Phase 3

United 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

759

EUCTR2015-000852-12-ES
(EUCTR)

20/07/2016

NCT02630966

TITLE A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn?s Disease SUMMARY The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV. The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. - ENTERPRISE

Fistulizing Crohn?s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 4

France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom

760

EUCTR2015-000481-58-NL
(EUCTR)

14/07/2016

15/02/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

761

EUCTR2015-000852-12-FR
(EUCTR)

13/07/2016

15/03/2019

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 4

United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom

762

EUCTR2016-000205-36-DE
(EUCTR)

11/07/2016

14/03/2016

A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD).

A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE

Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis)
MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: FE 999301

University Hospital Schleswig-Holstein (UKSH)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

763

EUCTR2016-001638-84-NL
(EUCTR)

08/07/2016

17/05/2016

Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study

Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study - ThiLDA-study

Crohn's disease & Colitis Ulcerosa;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Allopurinol Sandoz 100 mg, tabletten
INN or Proposed INN: ALLOPURINOL
INN or Proposed INN: ALLOPURINOL

Meander Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Netherlands

764

EUCTR2016-000678-40-HU
(EUCTR)

07/07/2016

19/05/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Hungary;Czech Republic;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of

765

EUCTR2015-000852-12-GB
(EUCTR)

07/07/2016

30/03/2016

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
INN or Proposed INN: vedolizumab

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United States;France;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

766

JPRN-UMIN000019958

2016/07/02

27/11/2015

Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments

Crohn's disease, ulcerative colitis

Patients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.

Iwate Medical UniversityKochi Medical School HospitalKeio University School of Medicine

NULL

Complete: follow-up continuing

15years-old

Not applicable

Male and Female

100

Not applicable

Japan

767

NCT02806206
(ClinicalTrials.gov)

July 2016

15/6/2016

Prucalopride Prior to Small Bowel Capsule Endoscopy

The Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled Trial

Gastrointestinal Hemorrhage;Crohn Disease;Celiac Disease;Intestinal Diseases;Inflammatory Bowel Diseases

Drug: Prucalopride;Drug: Placebo

University of British Columbia

NULL

Not yet recruiting

19 Years

N/A

Both

122

Phase 4

Canada

768

EUCTR2015-000482-31-BE
(EUCTR)

30/06/2016

14/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study

Ulcerative Colitis Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

769

EUCTR2015-000481-58-BE
(EUCTR)

30/06/2016

14/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden

770

JPRN-UMIN000022270

2016/06/30

01/07/2016

Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease

Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease - ADA2 study

Crohn's disease

double dose of adalimumab

Saitama Medical Center

NULL

Complete: follow-up complete

15years-old

80years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

771

EUCTR2016-000678-40-CZ
(EUCTR)

27/06/2016

18/05/2016

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

385

Phase 4

Serbia;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

772

EUCTR2015-001963-37-BG
(EUCTR)

23/06/2016

13/04/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

773

EUCTR2015-000555-24-NL
(EUCTR)

16/06/2016

10/02/2016

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB

Academic Medical Center Amsterdam

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

774

EUCTR2015-000481-58-DE
(EUCTR)

14/06/2016

09/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

775

EUCTR2015-000482-31-HR
(EUCTR)

13/06/2016

06/07/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

776

EUCTR2016-001278-13-FI
(EUCTR)

08/06/2016

15/04/2016

Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis

Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD

Ulcerative colitis and Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

Taina Sipponen

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Finland

777

EUCTR2015-001925-18-GR
(EUCTR)

01/06/2016

06/04/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

France;Australia;Denmark;Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

778

EUCTR2015-000481-58-DK
(EUCTR)

31/05/2016

17/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

779

EUCTR2015-000482-31-DK
(EUCTR)

31/05/2016

17/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

780

EUCTR2015-000481-58-ES
(EUCTR)

29/05/2016

20/04/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn s Disease

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn?s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn?s Disease

Crohn s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

781

EUCTR2015-000482-31-ES
(EUCTR)

29/05/2016

18/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study

Ulcerative ColitisCrohn?s Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium

782

EUCTR2015-000482-31-NL
(EUCTR)

25/05/2016

27/01/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

783

NCT02782663
(ClinicalTrials.gov)

May 18, 2016

23/5/2016

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

Crohn's Disease (CD)

Drug: ABT-494

AbbVie

NULL

Active, not recruiting

18 Years

75 Years

All

107

Phase 2

United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Romania;Slovakia;Spain;United Kingdom

784

EUCTR2015-002025-19-IT
(EUCTR)

17/05/2016

05/11/2020

An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally

A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: RPC1063
Product Code: [RPC1063]
INN or Proposed INN: Ozanimod
Product Name: RPC0163
Product Code: [RPC0163]
INN or Proposed INN: Ozanimod

CELGENE INTERNATIONAL II SàRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Canada;Poland;Ukraine;Italy

785

EUCTR2015-000609-38-DE
(EUCTR)

10/05/2016

28/01/2016

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

Allergan Limited

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

786

EUCTR2015-000482-31-HU
(EUCTR)

09/05/2016

22/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

787

EUCTR2015-001925-18-HR
(EUCTR)

09/05/2016

06/07/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

788

EUCTR2015-000481-58-HU
(EUCTR)

09/05/2016

22/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

824

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden

789

EUCTR2015-000482-31-DE
(EUCTR)

09/05/2016

09/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

790

EUCTR2015-001963-37-HR
(EUCTR)

05/05/2016

21/06/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

791

EUCTR2015-000482-31-LT
(EUCTR)

04/05/2016

18/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Colombia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden;Australia;Bosnia and Herzegovina;Russian Federation;Italy

792

EUCTR2015-000481-58-LT
(EUCTR)

04/05/2016

18/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden

793

EUCTR2015-001963-37-BE
(EUCTR)

03/05/2016

10/02/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

794

ChiCTR-OPC-16008655

2016-05-01

2016-06-16

Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China

Crohn‘s Disease

1:Thalidomide 75-100mg qd;2:Thalidomide 150-200mg qd;3:Thalidomide 75-100mg qd+MTX 20-25mg /W;

Peking Union Medical College Hospital

NULL

Recruiting

Both

1:90;2:90;3:90;

China

795

EUCTR2015-000609-38-BE
(EUCTR)

21/04/2016

25/02/2016

Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

796

EUCTR2015-001925-18-BG
(EUCTR)

20/04/2016

18/03/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

797

EUCTR2015-004618-10-BE
(EUCTR)

19/04/2016

20/11/2015

PhArmaCo-kinetics of InFliximab during treatment Induction

Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis

Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Inflectra

CUB- Hopital Erasme

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Belgium

798

JPRN-JapicCTI-163220

15/4/2016

08/04/2016

Vedolizumab Subcutaneous Long-Term Open-Label Extension Study

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease

Ulcerative colitis or Crohn's disease

Intervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to disease worsening or need for rescue medications will receive vedolizumab SC 108 mg QW.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Takeda Pharmaceutical Company Limited

NULL

complete

BOTH

692

Phase 3

Japan, Refer to Othersection

799

NCT02620046
(ClinicalTrials.gov)

April 15, 2016

19/11/2015

Vedolizumab Subcutaneous Long-Term Open-Label Extension Study

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease

Colitis, Ulcerative;Crohn Disease

Drug: Vedolizumab SC

Takeda

NULL

Active, not recruiting

18 Years

80 Years

All

692

Phase 3

United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic

800

EUCTR2015-001963-37-DK
(EUCTR)

15/04/2016

22/02/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

Sweden;Norway;Germany;New Zealand;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

801

EUCTR2015-001963-37-SK
(EUCTR)

14/04/2016

07/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

802

EUCTR2015-001925-18-SK
(EUCTR)

14/04/2016

30/11/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

803

EUCTR2015-000482-31-CZ
(EUCTR)

13/04/2016

21/01/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

804

EUCTR2015-000481-58-CZ
(EUCTR)

13/04/2016

21/01/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

805

EUCTR2015-001249-10-IS
(EUCTR)

12/04/2016

02/03/2016

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Germany;Iceland;United Kingdom;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

806

NCT02749630
(ClinicalTrials.gov)

April 11, 2016

12/4/2016

A 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 Disease

Ulcerative Colitis;Crohn's Disease

Drug: Placebo;Drug: UTTR1147A

Genentech, Inc.

NULL

Completed

18 Years

80 Years

All

Phase 1

Germany;United Kingdom;Canada

807

EUCTR2015-001963-37-ES
(EUCTR)

08/04/2016

03/02/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn?s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn?s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

808

NCT02750800
(ClinicalTrials.gov)

April 7, 2016

13/4/2016

Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis

Biological: Adalimumab;Behavioral: AbbVie Care 2.0

AbbVie

NULL

Completed

18 Years

99 Years

All

427

Hungary

809

EUCTR2015-000481-58-SE
(EUCTR)

05/04/2016

17/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

810

EUCTR2015-000482-31-SE
(EUCTR)

05/04/2016

16/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

811

NCT02685683
(ClinicalTrials.gov)

April 4, 2016

15/2/2016

Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease

A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease

Crohn's Disease

Drug: GED-0301

Celgene

NULL

Terminated

18 Years

N/A

All

Phase 2

Italy

812

EUCTR2015-000609-38-HU
(EUCTR)

04/04/2016

24/02/2016

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

Allergan Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

342

Phase 2

United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

813

EUCTR2015-001925-18-CZ
(EUCTR)

01/04/2016

22/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

814

JPRN-UMIN000020029

2016/04/01

01/12/2015

The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection

The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation

Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.

Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more.

Saitama Medical University

NULL

Recruiting

16years-old

Not applicable

Male and Female

300

Not selected

Japan

815

EUCTR2015-001963-37-CZ
(EUCTR)

01/04/2016

22/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn's disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

816

EUCTR2015-000481-58-BG
(EUCTR)

31/03/2016

16/02/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

817

EUCTR2015-000609-38-BG
(EUCTR)

30/03/2016

15/02/2016

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

Allergan Limited

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

818

EUCTR2015-001925-18-PT
(EUCTR)

28/03/2016

10/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

819

EUCTR2015-001963-37-PT
(EUCTR)

28/03/2016

10/02/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

820

EUCTR2015-001925-18-BE
(EUCTR)

25/03/2016

20/01/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

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;Serbia;Portugal;United States;Estonia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

821

EUCTR2015-000609-38-NL
(EUCTR)

24/03/2016

02/02/2016

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

822

EUCTR2015-000482-31-BG
(EUCTR)

23/03/2016

16/02/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: Entyvio
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

823

EUCTR2015-001963-37-IT
(EUCTR)

23/03/2016

23/02/2018

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: Mongersen

CELGENE CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

824

EUCTR2015-000482-31-GB
(EUCTR)

21/03/2016

08/03/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

825

EUCTR2015-001963-37-GB
(EUCTR)

15/03/2016

29/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

Portugal;United States;Serbia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Pakistan;Finland;Oman;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

826

EUCTR2015-000481-58-GB
(EUCTR)

14/03/2016

08/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

824

Phase 3

827

EUCTR2012-002702-51-NO
(EUCTR)

07/03/2016

03/02/2016

Discontinuation 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 study

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
Trade Name: Inflectra
Product Name: Inflectra
Product Code: EMEA/H/C/002778

Department of medical gastroenterology, Herlev Hospital

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 4

Finland;Denmark;Norway;Sweden

828

EUCTR2015-001925-18-ES
(EUCTR)

07/03/2016

04/01/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s disease

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn?s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

829

EUCTR2015-000609-38-IT
(EUCTR)

04/03/2016

21/02/2018

A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to SevereCrohn's Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - nd

Product Name: MEDI2070
Product Code: MEDI2070
Other descriptive name: anticorpo monoclonale anti-IL-23

MEDIMMUNE, LLC

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of

830

EUCTR2015-001925-18-DK
(EUCTR)

04/03/2016

06/01/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

831

NCT02538354
(ClinicalTrials.gov)

March 2016

20/8/2015

The Effect of Riboflavin in Crohn's Disease

The Effect of Riboflavin Supplementation on Faecalibacterium Prausnitzii in Crohn's Disease

Crohn Disease

Dietary Supplement: Riboflavin supplementation

University Medical Center Groningen

NULL

Completed

18 Years

65 Years

All

N/A

Netherlands

832

NCT02769494
(ClinicalTrials.gov)

March 2016

9/3/2016

The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease

Crohn's Disease;Oral Ulcer

Drug: Mesalazine Sustained-Release Tablets;Drug: Riboflavin Sodium Phosphate Injection

Xijing Hospital of Digestive Diseases

NULL

Recruiting

18 Years

65 Years

Both

Phase 3

China

833

EUCTR2015-000609-38-ES
(EUCTR)

29/02/2016

08/02/2016

A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn?s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

834

EUCTR2015-001963-37-DE
(EUCTR)

26/02/2016

11/01/2016

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

835

EUCTR2015-001925-18-GB
(EUCTR)

24/02/2016

18/11/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

836

EUCTR2015-001963-37-LV
(EUCTR)

18/02/2016

01/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

837

EUCTR2015-001925-18-LV
(EUCTR)

18/02/2016

01/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

838

EUCTR2015-001963-37-HU
(EUCTR)

15/02/2016

17/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

839

EUCTR2015-001925-18-HU
(EUCTR)

15/02/2016

17/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

840

EUCTR2015-000609-38-CZ
(EUCTR)

15/02/2016

29/01/2016

Product Name: MEDI2070
Product Code: MEDI2070
INN or Proposed INN: Not assigned
Other descriptive name: Anti-IL-23 monoclonal antibody

MedImmune Limited

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

841

EUCTR2015-001963-37-SE
(EUCTR)

10/02/2016

17/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

842

EUCTR2015-001925-18-DE
(EUCTR)

09/02/2016

07/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

843

EUCTR2015-001925-18-AT
(EUCTR)

29/01/2016

22/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

844

EUCTR2015-001963-37-AT
(EUCTR)

29/01/2016

22/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

845

EUCTR2015-002025-19-PL
(EUCTR)

28/01/2016

21/12/2015

An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 0.25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063

Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Canada;Poland;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

846

EUCTR2015-001925-18-SE
(EUCTR)

27/01/2016

25/11/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

847

NCT02925351
(ClinicalTrials.gov)

January 25, 2016

8/9/2016

Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases

The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases

Autoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu Arteritis

Procedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission Tomography

Jonsson Comprehensive Cancer Center

NULL

Completed

18 Years

N/A

All

Early Phase 1

United States

848

EUCTR2015-000481-58-SK
(EUCTR)

22/01/2016

05/01/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease

Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

824

Phase 3

849

EUCTR2015-000482-31-SK
(EUCTR)

22/01/2016

05/01/2016

Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease

Ulcerative ColitisCrohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Trade Name: ENTYVIO
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

692

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden

850

EUCTR2015-001678-17-NL
(EUCTR)

14/01/2016

A Pilot Study of FFP104 in Subjects with Crohn’s Disease

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects with Moderate to Severely Active Crohn’s Disease

Moderate to Severely Active Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: FFP104

Fast Forward Pharmaceuticals, B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

851

NCT02574637
(ClinicalTrials.gov)

January 5, 2016

24/9/2015

Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Crohn's Disease

Drug: Brazikumab IV Infusion;Drug: Brazikumab SC Injection;Drug: Placebo

Allergan

NULL

Terminated

18 Years

80 Years

All

Phase 2

United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Russian Federation;Spain;Bulgaria;Czech Republic;Korea, Republic of;Poland;Turkey;United Kingdom

852

NCT02611817
(ClinicalTrials.gov)

January 4, 2016

19/11/2015

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Crohn's Disease

Drug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mg

Takeda

NULL

Completed

18 Years

80 Years

All

644

Phase 3

United 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

853

JPRN-JapicCTI-163386

04/1/2016

28/09/2016

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Crohn's Disease

Intervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50

Takeda Pharmaceutical Company Limited

NULL

complete

BOTH

644

Phase 3

Japan, Refer to Othersection

854

ChiCTR-IIR-16007751

2016-01-01

2016-01-13

Clinical study of acupuncture and moxibustion treatment for Cohn's disease

Molecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease

Crohn's disease

Acupuncture 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 Meridian

NULL

Recruiting

Both

Acupuncture Group:40;Placebo acupuncture group:40;Drug Group:40;

I (Phase 1 study)

China

855

ChiCTR1800020305

2016-01-01

2018-12-23

A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease

Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI

crohn's disease;K50.900

Group 2:infliximab + azathioprine;Group 1:infliximab alone;

Department of Gastroenterology, Nanfang Hospital, Southern Medical University

NULL

Recruiting

Both

Group 2:41;Group 1:45;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

856

NCT02465944
(ClinicalTrials.gov)

January 2016

18/5/2015

A Pilot Study of FFP104 in Subjects With Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: FFP104;Drug: Placebo

Fast Forward Pharmaceuticals

NULL

Recruiting

18 Years

75 Years

Both

Phase 1;Phase 2

Belgium;Netherlands

857

NCT02680756
(ClinicalTrials.gov)

January 2016

9/2/2016

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

A 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 Disease

Anemia, Iron-Deficiency;Inflammatory Bowel Disease;Crohn's Disease

Drug: Ferric Maltol;Drug: Ferric Carboxy Maltose

Shield Therapeutics

NULL

Completed

18 Years

N/A

All

250

Phase 3

United States;Belgium;France;Germany;Hungary;Spain

858

NCT02532738
(ClinicalTrials.gov)

January 2016

23/8/2015

The Efficiency of MSC in Refractory Crohn's Disease

A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease

Crohn's Disease

Drug: Routine Treatment of CD;Biological: MSC treatment 01;Biological: MSC treatment 02;Other: NS

Sixth Affiliated Hospital, Sun Yat-sen University

Third Affiliated Hospital, Sun Yat-Sen University;Nanfang Hospital of Southern Medical University

Not yet recruiting

18 Years

65 Years

Both

Phase 2;Phase 3

NULL

859

EUCTR2015-002025-19-HU
(EUCTR)

30/12/2015

29/10/2015

An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Canada;Poland;Ukraine

860

EUCTR2015-001963-37-EE
(EUCTR)

29/12/2015

07/12/2015

A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1414

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

861

EUCTR2015-001925-18-EE
(EUCTR)

29/12/2015

07/12/2015

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1064

Phase 3

862

EUCTR2015-001249-10-GB
(EUCTR)

11/12/2015

06/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease

Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;Italy;New Zealand;United Kingdom

863

NCT02596893
(ClinicalTrials.gov)

December 8, 2015

3/11/2015

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

A 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

Crohn Disease

Drug: GED-0301;Drug: Placebo

Celgene

NULL

Terminated

18 Years

N/A

All

701

Phase 3

United 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

864

EUCTR2015-001678-17-BE
(EUCTR)

01/12/2015

10/09/2015

A Pilot Study of FFP104 in Subjects with Crohn’s Disease

Moderate to Severely Active Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: FFP104

Fast Forward Pharmaceuticals, B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands

865

NCT02678052
(ClinicalTrials.gov)

December 1, 2015

4/2/2016

OTIS Vedolizumab Pregnancy Exposure Registry

Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry

Colitis, Ulcerative;Crohn's Disease

Drug: Vedolizumab;Biological: Other Biological Agent

Takeda

NULL

Active, not recruiting

18 Years

44 Years

Female

300

United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

866

NCT02620007
(ClinicalTrials.gov)

December 2015

30/11/2015

Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease

Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease

Crohn Disease;Adherent-invasive E. Coli

Drug: Ciprofloxacin;Drug: Rifaximin;Drug: Ciprofloxacin Placebo;Drug: Rifaximin Placebo

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

80 Years

All

Phase 2

France

867

NCT02636517
(ClinicalTrials.gov)

December 2015

16/12/2015

Fecal Microbiome Transplant

Fecal Microbiome Transplant in Pediatric C. Difficile

Clostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis

Biological: Fecal Microbiota Transplant

Children's Hospital of Philadelphia

NULL

Active, not recruiting

3 Years

21 Years

All

N/A

United States

868

EUCTR2014-003240-12-NL
(EUCTR)

27/11/2015

21/04/2015

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

869

EUCTR2014-002311-41-DE
(EUCTR)

25/11/2015

21/08/2015

Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 4

France;Australia;Netherlands;Germany;United Kingdom;Sweden

870

EUCTR2015-001249-10-IT
(EUCTR)

11/11/2015

21/02/2018

An investigational study to assess the safety and effectiveness of a newinvestgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, MulticenterStudy Evaluating the Safety and Efficacy of GS-5745 in Subjects withModerately to Severely Active Crohn's Disease - GS-US-395-1663

Product Name: GS-5745
Product Code: nessuno

GILEAD SCIENCES INCORPORATED

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

871

EUCTR2015-001249-10-DE
(EUCTR)

02/11/2015

14/08/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand

872

NCT02330653
(ClinicalTrials.gov)

November 2015

29/12/2014

Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis

A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's Colitis

Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease

Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo

Stacy A. Kahn

NULL

Completed

5 Years

30 Years

All

Phase 1;Phase 2

United States

873

NCT02926300
(ClinicalTrials.gov)

November 2015

11/11/2015

Long-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 Disease

Crohn's Disease

Biological: stem cells

Kang Stem Biotech Co., Ltd.

NULL

Recruiting

19 Years

70 Years

All

Phase 1;Phase 2a

Korea, Republic of

874

NCT02622763
(ClinicalTrials.gov)

November 2015

1/12/2015

Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment

Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease

Crohn's Disease

Biological: Tolerogenic Dendritic Cells

Fundacion Clinic per a la Recerca Biomédica

NULL

Terminated

18 Years

65 Years

All

Phase 1

Spain

875

EUCTR2015-001834-15-NL
(EUCTR)

30/10/2015

11/08/2015

A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease

An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: BI 655066 10 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

876

EUCTR2014-003240-12-NO
(EUCTR)

19/10/2015

08/04/2015

Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden

877

EUCTR2014-005666-29-GB
(EUCTR)

16/10/2015

11/09/2015

A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's disease

A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease. - A study of Thetanix in young people with stable Crohn's disease

Crohn's disease in young persons
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

4D Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United Kingdom

878

EUCTR2014-004108-31-CZ
(EUCTR)

13/10/2015

02/06/2015

Study 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.

Moderately Active Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United Kingdom;Hungary;Czech Republic;Ukraine;Ireland;Russian Federation

879

EUCTR2012-002702-51-FI
(EUCTR)

12/10/2015

30/09/2015

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

Department of medical gastroenterology, Herlev Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Finland;Denmark;Norway;Sweden

880

NCT02531113
(ClinicalTrials.gov)

October 9, 2015

20/8/2015

Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

A 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 Therapy

Crohn's Disease

Drug: RPC1063

Celgene

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Canada;Hungary;Poland;Ukraine;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

881

EUCTR2014-003509-13-BE
(EUCTR)

06/10/2015

10/07/2015

Effect of Vedolizumab IV in subjects with Crohn's Disease

An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease

Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Czech Republic;Hungary;Canada;Poland;Belgium

882

EUCTR2015-001249-10-CZ
(EUCTR)

01/10/2015

14/08/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand

883

NCT02520843
(ClinicalTrials.gov)

October 2015

5/8/2015

An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF

An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction

Crohn Disease

Drug: stromal vascular fraction (SVF)

Assistance Publique Hopitaux De Marseille

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

France

884

EUCTR2013-003199-11-BE
(EUCTR)

25/09/2015

27/07/2015

CURE

Changing the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURE

Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Adalimumab
Product Name: Humira

GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

France;Belgium

885

EUCTR2015-001834-15-DE
(EUCTR)

24/09/2015

14/08/2015

A long term extension trial of BI 655066/ABBV-066 (risankizumab) in patients with moderately to severely active Crohn's disease

An open label, single group, long term safety extension trial of BI 655066/ABBV-066 (risankizumab), in patients with moderately to severely active Crohn's disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

886

EUCTR2015-001834-15-ES
(EUCTR)

24/09/2015

18/06/2015

A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease

An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease

Crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Boehringer Ingelheim España, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of

887

EUCTR2015-001249-10-HU
(EUCTR)

22/09/2015

10/08/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand

888

EUCTR2015-001249-10-ES
(EUCTR)

16/09/2015

11/09/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn?s Disease

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand

889

EUCTR2015-001954-14-NL
(EUCTR)

14/09/2015

25/08/2015

Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”

SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research

ulcerative colitis and Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion
Product Name: Inflectra 100 mg powder for concentrate for solution for infusion
Trade Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Code: EMEA/H/C/000240

Santeon

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

890

EUCTR2014-003824-36-DE
(EUCTR)

10/09/2015

25/03/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

891

EUCTR2014-003855-76-DE
(EUCTR)

09/09/2015

25/03/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

892

EUCTR2014-003824-36-NL
(EUCTR)

03/09/2015

02/04/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Product Name: Etrolizumab
Product Code: Ro 549-0261/F08-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden

893

EUCTR2014-003855-76-NL
(EUCTR)

03/09/2015

16/04/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

894

EUCTR2015-001834-15-BE
(EUCTR)

01/09/2015

01/07/2015

A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease

An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Belgium;Germany;Netherlands;Korea, Republic of

895

NCT02522169
(ClinicalTrials.gov)

September 2015

3/5/2015

TOPIT; 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 Disease

Verbessertes 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 Disease

Pediatric Crohns Disease

Drug: Infliximab

Klinikum Westbrandenburg GmbH

NULL

Not yet recruiting

6 Years

17 Years

Both

120

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

896

NCT03010787
(ClinicalTrials.gov)

September 2015

12/12/2016

A First Time in Human Study in Healthy Volunteers and Patients

A 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 Ileostomy

Crohn's Disease

Drug: V565;Drug: Placebo

VHsquared Ltd.

NULL

Completed

18 Years

65 Years

All

Phase 1

United Kingdom

897

EUCTR2014-004108-31-HU
(EUCTR)

27/08/2015

28/04/2015

Moderately Active Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

Czech Republic;Hungary;Slovakia;Belgium;Spain;Ukraine;Ireland;Russian Federation;Netherlands;Germany;United Kingdom

898

EUCTR2014-003240-12-PL
(EUCTR)

21/08/2015

09/06/2015

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

899

EUCTR2014-002311-41-SE
(EUCTR)

21/08/2015

01/07/2015

A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy

Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Imurel 25 mg
Product Name: Imurel
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE
Trade Name: Puri-Nethol 50 mg
Product Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Metoject
Product Name: Metotrexat
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 4

France;Netherlands;Germany;United Kingdom;Sweden

900

EUCTR2014-003509-13-PL
(EUCTR)

18/08/2015

12/06/2015

Effect of Vedolizumab IV in subjects with Crohn's Disease

Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Czech Republic;Hungary;Canada;Belgium;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

901

NCT02499783
(ClinicalTrials.gov)

August 17, 2015

14/7/2015

Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

A 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 Protein

Crohn's Disease

Biological: adalimumab;Other: placebo

AbbVie

NULL

Completed

18 Years

70 Years

All

205

Phase 3

China

902

EUCTR2014-003855-76-SE
(EUCTR)

12/08/2015

27/01/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

903

EUCTR2014-003824-36-SE
(EUCTR)

12/08/2015

27/01/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

904

EUCTR2012-002702-51-SE
(EUCTR)

10/08/2015

10/06/2015

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima

Department of medical gastroenterology S, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 4

Finland;Denmark;Norway;Sweden

905

EUCTR2014-004887-39-PL
(EUCTR)

08/08/2015

07/07/2015

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

906

NCT02538679
(ClinicalTrials.gov)

August 7, 2015

20/8/2015

A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques

A 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 Surgery

Crohn's Disease;Inflammatory Bowel Disease;Postoperative Pain

Other: Placebo;Drug: US TAP Bupivacaine/Epinephrine;Drug: Lap TAP Bupivacaine/Epinephrine

Cedars-Sinai Medical Center

NULL

Completed

18 Years

90 Years

All

127

N/A

NULL

907

EUCTR2014-003824-36-RO
(EUCTR)

05/08/2015

05/10/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Croatia;Romania;Germany;New Zealand;Sweden

908

NCT02452151
(ClinicalTrials.gov)

August 2015

20/5/2015

Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial

Santeon 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 Disease

Drug: Infliximab -Biosimilar;Drug: Infliximab -Innovator

Onze Lieve Vrouwe Gasthuis

Santeon

Not yet recruiting

18 Years

N/A

Both

300

Phase 4

NULL

909

NCT02389790
(ClinicalTrials.gov)

August 2015

10/3/2015

Extension Study of MT-1303 in Subjects With Crohn's Disease

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

Crohn's Disease

Drug: MT-1303

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

18 Years

65 Years

All

Phase 2

Czechia;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine;Czech Republic

910

EUCTR2014-003855-76-BE
(EUCTR)

29/07/2015

19/05/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

911

EUCTR2015-001179-36-PL
(EUCTR)

24/07/2015

01/06/2015

Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

RedHill Biopharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

324

Phase 3

Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand

912

EUCTR2014-003824-36-BE
(EUCTR)

17/07/2015

27/05/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

913

EUCTR2014-003240-12-IT
(EUCTR)

16/07/2015

28/02/2018

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABBVIE DEUTSCHLAND GMBH & CO. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

914

EUCTR2014-002311-41-GB
(EUCTR)

14/07/2015

30/06/2015

A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapy

Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Trade Name: Remicade
Product Name: INFLIXIMAB
Trade Name: Imuran
Product Name: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Mercaptopurine
Product Name: Mercaptopurine

University of Edinburgh

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

France;Belgium;Germany;United Kingdom;Sweden

915

EUCTR2014-003855-76-LV
(EUCTR)

02/07/2015

02/03/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

916

EUCTR2014-003824-36-LV
(EUCTR)

02/07/2015

26/02/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

917

NCT02269358
(ClinicalTrials.gov)

July 2015

30/9/2014

Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

Phase 4, Open Lable Non Randomized un Controlled Study. Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

Crohn's Disease

Drug: METHOTREXATE

Prof. Arie Levine

NULL

Completed

8 Years

18 Years

All

Phase 4

Israel

918

EUCTR2014-003855-76-AT
(EUCTR)

30/06/2015

26/05/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

919

EUCTR2014-005376-29-NL
(EUCTR)

29/06/2015

08/01/2015

An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.

An open-label observational phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD

Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio

Academic Medical Center, Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 4

Netherlands

920

EUCTR2012-004222-25-GR
(EUCTR)

25/06/2015

26/06/2015

Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease

A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors

Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 2;Phase 3

United States;Morocco;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Tunisia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

921

EUCTR2014-003509-13-CZ
(EUCTR)

25/06/2015

27/04/2015

Effect of Vedolizumab IV in subjects with Crohn's Disease

Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Czech Republic;Canada;Belgium;Poland

922

EUCTR2014-003855-76-HR
(EUCTR)

24/06/2015

01/10/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

923

EUCTR2014-003824-36-HR
(EUCTR)

24/06/2015

01/10/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

924

EUCTR2014-003240-12-ES
(EUCTR)

24/06/2015

27/03/2015

Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

925

EUCTR2014-003824-36-SK
(EUCTR)

23/06/2015

04/05/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A Phase III, Randomized, Double-Blind, Placebo-Controlled, MulticenterStudy to Evaluate the Efficacy and Safety of Etrolizumab as an Inductionand Maintenance Treatment for Patients with Moderately to Severely ActiveCrohn´s Disease

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

926

EUCTR2014-003855-76-SK
(EUCTR)

23/06/2015

07/05/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

An open-label extension and safety monitoring study of patients with moderately to severely active Crohn`s disease previously enrolled in the Etrolizumab phase III protocol GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

927

EUCTR2014-003240-12-DE
(EUCTR)

22/06/2015

25/03/2015

Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

928

EUCTR2014-003240-12-SK
(EUCTR)

22/06/2015

09/04/2015

Crohn's Disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

929

EUCTR2014-003240-12-BE
(EUCTR)

19/06/2015

18/03/2015

Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

930

EUCTR2014-003824-36-HU
(EUCTR)

15/06/2015

23/03/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

931

EUCTR2014-003855-76-HU
(EUCTR)

15/06/2015

23/03/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden

932

EUCTR2014-001050-41-DE
(EUCTR)

12/06/2015

15/12/2014

Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2

A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease - REACT2

Trade Name: Humira
Product Name: Humira

Robarts Clinical Trials

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 4

United States;Canada;Germany;United Kingdom

933

EUCTR2014-003240-12-DK
(EUCTR)

10/06/2015

31/03/2015

Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Denmark;Australia;Norway;Netherlands;Germany;New Zealand;Sweden

934

NCT02403323
(ClinicalTrials.gov)

June 8, 2015

26/3/2015

Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144

Crohn Disease

Drug: Etrolizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

N/A

All

900

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Luxembourg;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic

935

EUCTR2013-004034-15-BE
(EUCTR)

04/06/2015

05/01/2015

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

936

EUCTR2014-005376-29-BE
(EUCTR)

02/06/2015

03/02/2015

An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD

Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab

Academic Medical Center, Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 4

Belgium;Netherlands

937

EUCTR2014-001645-24-PL
(EUCTR)

29/05/2015

06/05/2015

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

Treatment of active Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

938

EUCTR2014-003824-36-AT
(EUCTR)

27/05/2015

21/04/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

939

EUCTR2014-003824-36-ES
(EUCTR)

27/05/2015

27/03/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE

Crohn`s Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Lithuania;Turkey;Austria;Russian Federation;Israel;Switzerland;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Latvia;New Zealand;Korea, Republic of;Serbia;United States;Estonia;Slovakia;Spain;Ukraine

940

EUCTR2014-003855-76-ES
(EUCTR)

27/05/2015

27/03/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Switzerland;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Latvia;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

941

EUCTR2014-003824-36-CZ
(EUCTR)

20/05/2015

31/03/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Mexico;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden

942

EUCTR2014-004904-31-NL
(EUCTR)

19/05/2015

26/01/2015

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

943

EUCTR2014-003509-13-HU
(EUCTR)

15/05/2015

13/04/2015

Vedolizumab IV in subjects with Crohn's Disease

Crohn's Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Czech Republic;Hungary;Canada;Belgium;Poland

944

EUCTR2010-020137-10-LT
(EUCTR)

13/05/2015

12/03/2015

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

945

EUCTR2014-003240-12-HU
(EUCTR)

11/05/2015

25/03/2015

Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

946

EUCTR2014-003855-76-CZ
(EUCTR)

11/05/2015

12/05/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden

947

EUCTR2013-004034-15-FR
(EUCTR)

07/05/2015

22/06/2015

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

948

EUCTR2014-003240-12-CZ
(EUCTR)

04/05/2015

07/05/2015

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT- 494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy

Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

949

NCT02256462
(ClinicalTrials.gov)

May 1, 2015

26/9/2014

Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial

Crohn's Disease

Drug: Adalimumab

Schneider Children's Medical Center, Israel

NULL

Completed

6 Years

17 Years

All

Phase 4

Israel

950

NCT02575040
(ClinicalTrials.gov)

May 2015

6/10/2015

Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease

Ulcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction)

Biological: Fecal microbiota transplantation

Gulhane Military Medical Academy

NULL

Recruiting

18 Years

N/A

Both

Phase 3

Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

951

NCT02413047
(ClinicalTrials.gov)

May 2015

6/3/2015

Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator

Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease

Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate

Indiana University

NULL

Terminated

18 Years

80 Years

All

N/A

United States

952

NCT02405442
(ClinicalTrials.gov)

April 30, 2015

27/3/2015

Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: Andecaliximab;Drug: Placebo

Gilead Sciences

NULL

Terminated

18 Years

75 Years

All

187

Phase 2

United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Czech Republic;Iceland

953

EUCTR2014-003824-36-FR
(EUCTR)

17/04/2015

25/06/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Croatia;Germany;New Zealand;Sweden

954

EUCTR2014-003855-76-FR
(EUCTR)

17/04/2015

25/06/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Switzerland;France;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Latvia;New Zealand;Korea, Republic of

955

EUCTR2014-003855-76-EE
(EUCTR)

15/04/2015

17/02/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Crohn`s Disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

956

EUCTR2014-003824-36-EE
(EUCTR)

15/04/2015

17/02/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Crohn`s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1250

Phase 3

957

EUCTR2014-003824-36-LT
(EUCTR)

10/04/2015

18/02/2015

A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden

958

EUCTR2014-003855-76-LT
(EUCTR)

10/04/2015

18/02/2015

An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden

959

EUCTR2014-002557-19-NL
(EUCTR)

10/04/2015

03/11/2014

A 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 study

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study

Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy

960

NCT02367183
(ClinicalTrials.gov)

April 8, 2015

13/2/2015

A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

A 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 Disease

Drug: GED-0301;Drug: Placebo

Celgene

NULL

Completed

18 Years

N/A

All

Phase 1

United States;Australia;Canada;Hungary;Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

961

EUCTR2014-005702-37-NL
(EUCTR)

08/04/2015

12/02/2015

Early infliximab use in kids with Crohn's disease (TISKids)

Top-Down Infliximab Study in Kids with Crohn's disease (TISKids) - Top-down Infliximab in Kids with Crohn's disease (TISKids)

Crohn's disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Inflectra

Erasmus Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Netherlands

962

NCT02675153
(ClinicalTrials.gov)

April 1, 2015

21/1/2016

To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture

Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture

Crohn's Diseases

Drug: Rapamycin

The Second Hospital of Nanjing Medical University

NULL

Recruiting

18 Years

N/A

All

N/A

China

963

NCT02851134
(ClinicalTrials.gov)

April 2015

7/6/2016

Search for New Genetic Mutations Major Effect in Crohn's Disease

Crohn Disease

Genetic: genetic analysis;Biological: blood and stools samples

University Hospital, Lille

NULL

Completed

5 Years

80 Years

All

France

964

NCT02580617
(ClinicalTrials.gov)

April 2015

15/10/2015

A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease

A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease

Crohn's Disease

Biological: ALLO-ASC

Anterogen Co., Ltd.

NULL

Unknown status

18 Years

65 Years

All

Phase 1

Korea, Republic of

965

NCT02674308
(ClinicalTrials.gov)

March 31, 2015

29/1/2016

Entyvio (Vedolizumab) Long Term Safety Study

Entyvio (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 Disease

Ulcerative Colitis and Crohn's Disease

Drug: Vedolizumab;Other: Other Biologic Agents

Takeda

NULL

Active, not recruiting

18 Years

N/A

All

5302

United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

966

EUCTR2013-004034-15-IT
(EUCTR)

31/03/2015

03/10/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

967

NCT02425111
(ClinicalTrials.gov)

March 30, 2015

26/3/2015

Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

Crohn's Disease

Drug: Vedolizumab

Takeda

NULL

Completed

18 Years

80 Years

All

101

Phase 3

United States;Belgium;Canada;Czechia;France;Hungary;Italy;Poland;Czech Republic

968

EUCTR2014-002557-19-PL
(EUCTR)

30/03/2015

21/01/2015

A 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 study

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy

969

EUCTR2014-002556-77-PL
(EUCTR)

30/03/2015

20/01/2015

A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease

A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease

Subjects with moderate to severe crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy

970

EUCTR2014-002556-77-NL
(EUCTR)

26/03/2015

03/11/2014

A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

971

NCT02394028
(ClinicalTrials.gov)

March 20, 2015

27/2/2015

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Placebo;Drug: Etrolizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

80 Years

All

1150

Phase 3

972

NCT03306446
(ClinicalTrials.gov)

March 17, 2015

21/6/2015

Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab

Drug: Start adalimumab in monotherapy

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Active, not recruiting

18 Years

75 Years

All

203

Phase 4

Belgium;France

973

NCT02365649
(ClinicalTrials.gov)

March 17, 2015

16/2/2015

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

Crohn's Disease

Drug: ABT-494;Drug: Placebo

AbbVie

NULL

Completed

18 Years

75 Years

All

219

Phase 2

United 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

974

EUCTR2014-001644-38-PL
(EUCTR)

13/03/2015

30/12/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

975

EUCTR2013-004034-15-DK
(EUCTR)

06/03/2015

27/10/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

976

NCT01836289
(ClinicalTrials.gov)

March 2015

17/4/2013

High-dose Cyclophosphamide for Severe Refractory Crohn Disease

Crohn's Disease;Crohn Disease

Drug: High-dose Cyclophosphamide

Johns Hopkins University

NULL

Withdrawn

18 Years

100 Years

All

Phase 1;Phase 2

United States

977

NCT02378688
(ClinicalTrials.gov)

March 2015

27/2/2015

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Crohn's Disease

Drug: MT-1303;Drug: Placebo

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

18 Years

65 Years

Both

Phase 2

Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine

978

NCT02392286
(ClinicalTrials.gov)

March 2015

12/3/2015

Corticosteroid Dosage for Crohn's Disease Flare

A 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 Flares

Crohn's Disease;Inflammatory Bowel Disease

Drug: Corticosteroid

Yale University

NULL

Terminated

18 Years

N/A

All

Phase 4

United States

979

EUCTR2013-002902-29-NL
(EUCTR)

12/02/2015

25/02/2014

Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BI 655066 10 mg/ml
Product Code: BI 655066 10 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Product Name: BI 655066 90 mg/ml
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066

Boehringer Ingelheim bv

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of

980

EUCTR2014-001645-24-DE
(EUCTR)

09/02/2015

01/10/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Treatment of active Crohn’s disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

981

EUCTR2013-004034-15-DE
(EUCTR)

09/02/2015

29/08/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

982

EUCTR2014-001644-38-DE
(EUCTR)

02/02/2015

18/09/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

983

NCT02061163
(ClinicalTrials.gov)

February 2015

6/2/2014

Contrast-Enhanced Ultrasound in Human Crohn's Disease

Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease

Crohn's Disease

Device: Contrast Enhanced Ultrasound;Drug: Optison

University of Michigan

NULL

Withdrawn

10 Years

N/A

Both

Phase 1;Phase 2

United States

984

EUCTR2013-004034-15-GB
(EUCTR)

27/01/2015

29/08/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

985

EUCTR2014-002556-77-SK
(EUCTR)

20/01/2015

03/11/2014

A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

986

EUCTR2014-002557-19-SK
(EUCTR)

20/01/2015

03/11/2014

A 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 study

Subjects with moderate to severe crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy

987

EUCTR2013-001746-33-FR
(EUCTR)

14/01/2015

22/06/2015

A 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 Ulceration

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands

988

EUCTR2013-001746-33-BE
(EUCTR)

12/01/2015

03/04/2014

A 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 Ulceration

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands

989

EUCTR2014-001644-38-CZ
(EUCTR)

09/01/2015

19/09/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

Treatment of active Crohn’s disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN

Salix Pharmaceuticals, Inc. subsidiary of Valeant Pharmaceuticals International In

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

990

EUCTR2014-001645-24-CZ
(EUCTR)

09/01/2015

30/09/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN

Salix Pharmaceuticals, Inc subsidiary of Valeant Pharmaceuticals International Inc

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

991

EUCTR2014-002556-77-IT
(EUCTR)

03/01/2015

11/11/2014

A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease

Subjects with moderate to severe crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy

992

EUCTR2014-002557-19-IT
(EUCTR)

03/01/2015

10/11/2014

A 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 study

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy

993

JPRN-UMIN000032485

2015/01/01

08/05/2018

efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease

efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study

Cron's disease

adalimumab
azathiopurine

Sakura medical center, Toho university

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

Not selected

Japan

994

NCT02335281
(ClinicalTrials.gov)

January 2015

7/1/2015

Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease

Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease

Procedure: FMT;Drug: Mesalazine

Yanling Wei

NULL

Recruiting

16 Years

70 Years

Both

Phase 2

China

995

NCT02272868
(ClinicalTrials.gov)

January 2015

16/10/2014

Fecal Microbial Transplant in Pediatric Crohn's Disease

Fecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control Study

Crohn's Disease

Biological: Fecal Microbial transplant;Drug: Normal Saline;Drug: rifaximin +omeprazole+miralax

Seattle Children's Hospital

NULL

Completed

12 Years

21 Years

All

Phase 1;Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

996

EUCTR2013-002902-29-DE
(EUCTR)

22/12/2014

08/08/2014

Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease.

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: Risankizumab 10 mg/ml
INN or Proposed INN: Risankizumab
Product Code: Risankizumab 90 mg/ml
INN or Proposed INN: Risankizumab

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of

997

EUCTR2013-004034-15-AT
(EUCTR)

11/12/2014

12/11/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

998

EUCTR2013-004034-15-SK
(EUCTR)

10/12/2014

13/10/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

999

EUCTR2013-002838-20-BE
(EUCTR)

09/12/2014

15/09/2014

The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease

The effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT

Trade Name: D-CURA
Product Name: D-Cura
INN or Proposed INN: Cholecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)

Academic Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

142

Phase 3

Belgium;Netherlands

1000

EUCTR2014-001892-30-HU
(EUCTR)

08/12/2014

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's disease

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Disease

Crohn’s Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Germany;United Kingdom;Russian Federation;France;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1001

EUCTR2014-001644-38-FR
(EUCTR)

08/12/2014

22/06/2015

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Treatment of active Crohn’s disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

1002

EUCTR2014-001295-65-IT
(EUCTR)

01/12/2014

27/11/2014

Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease

A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, multi-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29

Moderately to severely active Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population
Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population

TxCell

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Belgium;Austria;Germany;Italy

1003

EUCTR2014-001295-65-AT
(EUCTR)

01/12/2014

19/11/2014

Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease

A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29

Moderately to severely active Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population

TxCell

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Belgium;Austria;Germany;Italy

1004

NCT02249078
(ClinicalTrials.gov)

December 2014

23/9/2014

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: E6011;Drug: Placebo

Eisai Inc.

NULL

Withdrawn

18 Years

N/A

Both

Phase 1

NULL

1005

NCT02327221
(ClinicalTrials.gov)

December 2014

23/12/2014

Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease

A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease

Crohn Disease

Drug: Ovasave;Drug: Placebo

TxCell

NULL

Terminated

18 Years

70 Years

All

Phase 2

Austria;Belgium;France;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1006

EUCTR2013-001746-33-NL
(EUCTR)

28/11/2014

22/04/2014

A 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 Ulceration

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands;Germany

1007

EUCTR2014-001295-65-BE
(EUCTR)

28/11/2014

17/11/2014

Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease

A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and parallel-group study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn's Disease (Crohn's And Treg Study: CATS29) - CATS29

Moderately to severely active Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population

TxCell

NULL

Not Recruiting

Female: yes
Male: yes

117

Phase 2

Belgium;Austria;Germany;Italy

1008

EUCTR2014-002557-19-CZ
(EUCTR)

27/11/2014

30/09/2014

A 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 study

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy

1009

EUCTR2014-002556-77-CZ
(EUCTR)

27/11/2014

30/09/2014

A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy

1010

EUCTR2014-001295-65-DE
(EUCTR)

25/11/2014

19/11/2014

Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease

Product Name: Ovasave
INN or Proposed INN: Ova-Treg
Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population

TxCell

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Belgium;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1011

EUCTR2013-004034-15-ES
(EUCTR)

25/11/2014

22/09/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Denmark

1012

EUCTR2014-001892-30-BE
(EUCTR)

24/11/2014

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's disease

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Russian Federation;Germany;United Kingdom

1013

EUCTR2014-001644-38-HU
(EUCTR)

18/11/2014

17/09/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Treatment of active Crohn’s disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany

1014

EUCTR2014-002557-19-HU
(EUCTR)

18/11/2014

09/10/2014

A 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 study

Subjects with moderate to severe crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy

1015

EUCTR2014-002556-77-HU
(EUCTR)

18/11/2014

09/10/2014

A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease

Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303

Mitsubishi Tanabe Pharma Corporation (MTPC)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1016

EUCTR2014-001645-24-FR
(EUCTR)

18/11/2014

22/06/2015

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Product Name: Rifaximin Delayed Release (DR)
INN or Proposed INN: RIFAXIMIN

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany

1017

EUCTR2014-001645-24-HU
(EUCTR)

18/11/2014

24/09/2014

A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks.

Salix Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany

1018

EUCTR2014-000261-51-FR
(EUCTR)

04/11/2014

28/08/2015

Randomized, controlled, double bind study, comparing curcumin to placebo, associated with thiopurines, in the the prevention of post-operative Crohn's desease relapse

POPCUR : a randomized, controlled, double bind study, comparing curcuma to placebo, associated with thiopurines, in the prevention of post-operative Crohn's disease recurrence - POPCUR

Product Name: Curcuma
Other descriptive name: CURCUMA LONGA RHIZOMA

CHU de Clermont-Ferrand

NULL

Not Recruiting

Female: yes
Male: yes

122

Phase 3

France

1019

NCT02426567
(ClinicalTrials.gov)

November 2014

17/4/2015

The Impact of Crohn's Disease-TReatment-with-EATing Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria

An Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic Activity

Crohn's Disease;Dietary Modification

Other: Exclusive Enteral Nutrition (EEN);Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)

University of Glasgow

NULL

Completed

18 Years

N/A

Both

N/A

United Kingdom

1020

EUCTR2013-004497-10-RO
(EUCTR)

31/10/2014

02/06/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1021

EUCTR2013-001746-33-DK
(EUCTR)

23/10/2014

15/05/2014

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands

1022

EUCTR2013-001746-33-DE
(EUCTR)

08/10/2014

01/04/2014

A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses forInduction and Maintenance Therapy in Subjects with Moderately toSeverely Active Crohn's Disease and Evidence of Mucosal Ulceration

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands

1023

EUCTR2013-004034-15-HU
(EUCTR)

07/10/2014

25/08/2014

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany

1024

EUCTR2014-003141-10-BE
(EUCTR)

29/09/2014

26/09/2014

Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie.

Crohn's disease or colitis ulcerosa
MedDRA version: 17.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: UrsoFalk ® 250 mg tabletten.
Product Name: UrsoFalk
INN or Proposed INN: ursodeoxycholic acid
Other descriptive name: URSODEOXYCHOLIC ACID

Ghent University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

1025

EUCTR2013-004497-10-GB
(EUCTR)

16/09/2014

23/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1026

EUCTR2013-004497-10-DK
(EUCTR)

11/09/2014

02/06/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

1027

EUCTR2013-001746-33-IT
(EUCTR)

09/09/2014

10/04/2014

A 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 Ulceration

Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands

1028

JPRN-UMIN000015770

2014/09/01

01/12/2014

Randomized 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 Index

Standard therapy for Crohn's disease (Pentasa 3 g/day)
Patients take curcumin or placebo

Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

Not selected

Japan

1029

NCT02332356
(ClinicalTrials.gov)

September 2014

4/1/2015

Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

Crohn Disease

Drug: azathioprine or adalimumab and infliximab

Tokyo Medical and Dental University

NULL

Recruiting

16 Years

65 Years

All

100

Phase 3

Japan

1030

EUCTR2013-005629-21-HU
(EUCTR)

14/08/2014

11/06/2014

Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease

Crohn’s disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab
INN or Proposed INN: INFLIXIMAB

First Department of Medicine, University of Szeged

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1031

NCT02185014
(ClinicalTrials.gov)

August 12, 2014

7/7/2014

Open 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 M14-115

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

Crohn's Disease

Drug: Adalimumab

AbbVie

NULL

Completed

18 Years

75 Years

All

252

Phase 3

Austria;Belgium;Canada;Czech Republic;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;United States

1032

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

1033

EUCTR2014-002311-41-FR
(EUCTR)

12/08/2014

22/06/2015

Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

France;United Kingdom;Sweden

1034

EUCTR2013-003199-11-FR
(EUCTR)

12/08/2014

26/03/2018

CURE

Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY - CURE

Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: ADALIMUMAB
Product Name: HUMIRA

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

France;Belgium

1035

EUCTR2013-004497-10-NL
(EUCTR)

06/08/2014

03/06/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1036

JPRN-UMIN000014006

2014/08/01

31/07/2014

Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease

Crohn's disease

dose escalation of infliximab

IBD Center, Sapporo Kosei General Hospital

NULL

Recruiting

18years-old

Not applicable

Male and Female

Not selected

Japan

1037

EUCTR2013-004497-10-IT
(EUCTR)

01/08/2014

27/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

1038

NCT02000362
(ClinicalTrials.gov)

August 2014

7/11/2013

Safety 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 Disease

Crohn's Disease

Biological: Stem cells

Kang Stem Biotech Co., Ltd.

NULL

Recruiting

19 Years

70 Years

All

Phase 1;Phase 2

Korea, Republic of

1039

EUCTR2013-004497-10-ES
(EUCTR)

25/07/2014

27/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

1040

EUCTR2013-004497-10-BE
(EUCTR)

16/07/2014

12/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1041

EUCTR2013-001746-33-CZ
(EUCTR)

10/07/2014

15/05/2014

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Netherlands

1042

EUCTR2013-004497-10-HU
(EUCTR)

02/07/2014

22/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

1043

NCT02199561
(ClinicalTrials.gov)

July 2014

22/7/2014

Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

Crohn's Disease

Biological: Fecal Microbiota Transplant

University of Alberta

NULL

Completed

18 Years

65 Years

Both

Phase 1;Phase 2

Canada

1044

EUCTR2013-005013-13-PL
(EUCTR)

25/06/2014

31/03/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of

1045

EUCTR2013-001746-33-ES
(EUCTR)

23/06/2014

25/04/2014

A 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 Ulceration

Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1046

EUCTR2013-001746-33-HU
(EUCTR)

18/06/2014

23/04/2014

A 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 Ulceration

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands

1047

EUCTR2013-001746-33-SK
(EUCTR)

10/06/2014

15/04/2014

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands

1048

EUCTR2013-001746-33-AT
(EUCTR)

05/06/2014

15/05/2014

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands

1049

NCT02179372
(ClinicalTrials.gov)

June 2014

29/6/2014

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases

Ulcerative Colitis;Crohn's Disease

Dietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo)

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

NULL

Completed

18 Years

80 Years

Both

N/A

Italy

1050

NCT02164877
(ClinicalTrials.gov)

June 2014

13/6/2014

Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease

A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease

Crohn's Disease

Drug: pectin

Jinling Hospital, China

NULL

Terminated

17 Years

40 Years

All

Phase 2

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1051

NCT02148185
(ClinicalTrials.gov)

May 2014

20/5/2014

Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: MT-1303

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

20 Years

65 Years

Both

Phase 1

Japan

1052

NCT01881464
(ClinicalTrials.gov)

May 2014

11/6/2013

Anti TNF a Improves Endothelial Dysfunction in IBD Patients

Crohn's Disease

Device: Endopath from Itamar medical - FDA approved device.;Drug: Anti TNF Alfa.

Carmel Medical Center

NULL

Recruiting

18 Years

40 Years

Both

Israel

1053

EUCTR2013-005013-13-BG
(EUCTR)

28/04/2014

23/04/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Phase 3

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

1054

EUCTR2012-004222-25-SK
(EUCTR)

28/04/2014

09/01/2014

Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease

Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Czech Republic;Morocco;Slovakia;Greece;Belgium;Spain;Tunisia;India

1055

EUCTR2013-004781-34-ES
(EUCTR)

16/04/2014

25/02/2014

Rapidity 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.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: ADALIMUMAB
INN or Proposed INN: ADALIMUMAB

AbbVie Farmacéutica S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1056

NCT02065570
(ClinicalTrials.gov)

April 9, 2014

17/2/2014

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Crohn's Disease

Drug: Adalimumab

AbbVie

NULL

Completed

18 Years

75 Years

All

514

Phase 3

United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic

1057

EUCTR2013-005013-13-LT
(EUCTR)

08/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

1058

EUCTR2013-005013-13-CZ
(EUCTR)

03/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

1059

EUCTR2013-002857-32-PL
(EUCTR)

02/04/2014

03/02/2014

A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Hungary;Czech Republic;Belgium;Poland;Romania;Russian Federation;Germany;United Kingdom

1060

JPRN-UMIN000013369

2014/04/01

20/03/2014

Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's disease

Crohn's disease

Oral 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 medicine

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

240

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1061

EUCTR2013-001029-17-NL
(EUCTR)

01/04/2014

17/05/2013

Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentration

Efficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX

Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab

Academic Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1062

NCT02913508
(ClinicalTrials.gov)

April 2014

22/9/2016

Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease

A 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 Disease

Ulcerative Colitis;Crohn's Disease

Drug: Vedolizumab intravenous injection;Drug: Vedolizumab subcutaneous injection

Takeda

NULL

Withdrawn

18 Years

80 Years

Both

Phase 2

NULL

1063

ChiCTR-DDT-14004402

2014-03-28

2014-03-09

The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fasting

Obscure gastrointestinal bleeding, iron deficiency anemia , Suspected Crohn’s disease, Suspected small bowel tumors, Surveillance of polyposis syndromes, malabsorption? Celiac disease, nonsteroidal a

Group 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 University

NULL

Completed

Both

Group A:60;Group B:60;Group C:60;

4 (Phase 4 study)

China

1064

EUCTR2013-002857-32-GB
(EUCTR)

18/03/2014

05/11/2013

A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom

1065

EUCTR2011-000722-30-SE
(EUCTR)

17/03/2014

13/02/2014

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Crohn’s disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1066

NCT02039063
(ClinicalTrials.gov)

March 14, 2014

9/1/2014

A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease

Crohn's Disease

Drug: E6011 2 mg/kg;Drug: E6011 5 mg/kg;Drug: E6011 10 mg/kg;Drug: E6011 15 mg/kg

EA Pharma Co., Ltd.

NULL

Completed

20 Years

64 Years

All

Phase 1;Phase 2

Japan

1067

EUCTR2013-002651-15-NL
(EUCTR)

03/03/2014

18/09/2013

Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.

Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study

Crohns diseaseUlcerative colitis
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade (infliximab)
Product Name: infliximab

Zon MW

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

1068

NCT02088944
(ClinicalTrials.gov)

March 2014

13/3/2014

a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease

Serological C Reactive Protein or Erythrocyte Sedimentation Rate

Drug: Infliximab

Nanfang Hospital of Southern Medical University

NULL

Not yet recruiting

18 Years

75 Years

Both

142

N/A

NULL

1069

EUCTR2013-002857-32-DE
(EUCTR)

20/02/2014

30/10/2013

A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom

1070

NCT02060318
(ClinicalTrials.gov)

February 11, 2014

10/2/2014

Regulatory T-cells and Crohn's Disease

The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells

Crohn Disease

Drug: Infliximab

Hvidovre University Hospital

NULL

Completed

18 Years

N/A

All

N/A

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1071

EUCTR2013-002857-32-BE
(EUCTR)

03/02/2014

07/11/2013

A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom

1072

JPRN-UMIN000012790

2014/02/01

01/02/2014

Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease

Crohn's disease

dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months

Saitama Medical center

NULL

Complete: follow-up complete

20years-old

65years-old

Male and Female

Not selected

Japan

1073

NCT02048618
(ClinicalTrials.gov)

February 2014

27/1/2014

Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

Crohn's Disease

Drug: GLPG0634;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

75 Years

Both

175

Phase 2

Belgium;Czech Republic;France;Germany;Hungary;Poland;Romania;Russian Federation;United Kingdom

1074

NCT01932658
(ClinicalTrials.gov)

February 2014

28/6/2013

Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment

Crohn's Disease

Biological: Hematopoietic stem cell transplantation

University of California, Los Angeles

NULL

Withdrawn

7 Years

70 Years

Both

Phase 0

United States

1075

JPRN-JapicCTI-142402

28/1/2014

27/12/2013

Phase III study of MLN0002 (300 mg) in treatment of Crohn's disease

Phase III, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe Crohn's disease

Crohn's disease

Intervention 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 Limited

NULL

complete

BOTH

157

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1076

NCT02038920
(ClinicalTrials.gov)

January 28, 2014

15/1/2014

Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease

Crohn's Disease

Drug: Vedolizumab;Drug: Vedolizumab placebo

Takeda

NULL

Completed

15 Years

80 Years

All

157

Phase 3

Japan

1077

EUCTR2013-002857-32-CZ
(EUCTR)

21/01/2014

04/11/2013

A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Crohn’s Disease With Evidence of Mucosal Ulceration
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom

1078

EUCTR2013-002857-32-HU
(EUCTR)

16/01/2014

04/11/2013

A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Czech Republic;Hungary;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom

1079

EUCTR2013-002902-29-BE
(EUCTR)

09/01/2014

20/09/2013

Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066

SCS Boehringer Ingelheim Comm.V

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of

1080

EUCTR2013-002902-29-ES
(EUCTR)

09/01/2014

05/12/2013

Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: BI 655066 10 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066

Boehringer Ingelheim España, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1081

NCT02349594
(ClinicalTrials.gov)

January 2014

16/1/2015

Immune Modulation by Parenteral Fish Oil in Patients With Crohn's Disease

Modulation of Immune Function by Parenteral Fish Oil in Patients With Crohn's Disease and High Inherent Tumor Necrosis Factor-alpha Production: a Randomized, Single Blinded, Cross-over Study

Crohn Disease

Drug: Omegaven 10%;Drug: Intralipid 20%

Radboud University

NULL

Completed

18 Years

70 Years

Both

Phase 4

Netherlands

1082

NCT02227602
(ClinicalTrials.gov)

January 2014

4/6/2014

Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease

The Mango Consumption Improves Biomarkers for Inflammation in Inflammatory Bowel Disease Patients

Intestinal Diseases;Ulcerative Colitis;Crohn Disease

Drug: Mango polyphenolics

Texas A&M University

NULL

Completed

18 Years

72 Years

All

N/A

United States

1083

NCT02056418
(ClinicalTrials.gov)

January 2014

24/1/2014

Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult

A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult

Crohn Disease

Dietary Supplement: enteral nutrition;Drug: corticosteroid

Jinling Hospital, China

NULL

Active, not recruiting

18 Years

75 Years

Both

Phase 4

China

1084

NCT02044952
(ClinicalTrials.gov)

January 2014

19/1/2014

Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

Inflammatory Bowel Diseases;Crohn's Disease;Gastrointestinal Diseases;Digestive System Diseases;Intestinal Diseases

Drug: Mesalazine , Tripterygium glycosides

Zhu Weiming

NULL

Recruiting

18 Years

75 Years

Both

Phase 2;Phase 3

China

1085

NCT02615288
(ClinicalTrials.gov)

January 2014

23/11/2015

High Dose Vitamin D3 in Crohn's Disease

Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study

Crohn's Disease

Dietary Supplement: Vitamin D3

McMaster University

Canadian Association of Gastroenterology

Completed

18 Years

70 Years

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1086

EUCTR2012-005226-29-PT
(EUCTR)

20/12/2013

24/09/2013

Antibiotic therapy for children with active Crohn's disease

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: azithromycin
INN or Proposed INN: azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: metronidazole
Product Name: metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: Metronidazole

Centro Hospitalar de São João E.P.E.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Portugal;Canada;Poland;Belgium;Israel;Netherlands

1087

EUCTR2011-001332-29-AT
(EUCTR)

02/12/2013

07/11/2013

The degradation and elimination of Infliximab

Pharmacokinetics of Infliximab

Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

1088

NCT02015793
(ClinicalTrials.gov)

December 2013

13/12/2013

Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

A 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 Protein

Crohn's Disease

Biological: Adalimumab;Biological: Placebo for adalimumab

AbbVie

NULL

Completed

18 Years

70 Years

All

Phase 2

China

1089

EUCTR2010-023034-23-SE
(EUCTR)

29/11/2013

01/11/2013

A 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 Responsers

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE

Crohn's Disease (active moderate to severe)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

1090

EUCTR2012-004222-25-BE
(EUCTR)

26/11/2013

14/01/2013

Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease

A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease

Crohn's disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable

AB Science

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

United 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.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1091

EUCTR2011-000722-30-AT
(EUCTR)

19/11/2013

15/10/2013

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden

1092

EUCTR2013-002838-20-NL
(EUCTR)

12/11/2013

06/09/2013

The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease

The effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT

Trade Name: InVita D3
INN or Proposed INN: Colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE

Academic Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

142

Phase 3

Belgium;Netherlands

1093

EUCTR2011-003622-27-NL
(EUCTR)

30/10/2013

19/02/2013

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden

1094

EUCTR2010-023034-23-AT
(EUCTR)

10/10/2013

20/08/2013

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

1095

EUCTR2012-001723-12-ES
(EUCTR)

07/10/2013

14/08/2013

adalimumab intralesional in intestinal strictures of Crohn's disease patients

A randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients

Crohn disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Fundació Clínic per a la Recerca Biomèdica

NULL

Not Recruiting

Female: yes
Male: yes

102

Phase 3

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1096

NCT02859675
(ClinicalTrials.gov)

October 7, 2013

28/7/2016

Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease

Crohn's Disease;Olfactogustatory Perception

Other: triangular test;Biological: blood sampling;Other: Questionnaires

Centre Hospitalier Universitaire Dijon

NULL

Recruiting

18 Years

60 Years

Female

France

1097

EUCTR2012-000645-13-BE
(EUCTR)

09/09/2013

16/07/2013

Infliximab as firsdt treatment instead of second line treatment in Crohns disease

Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade

ErasmusMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium;Netherlands

1098

JPRN-JapicCTI-142426

01/9/2013

A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease

Crohn's Disease

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 80mg every other week
Control intervention name : null

AbbVie GK

NULL

BOTH

Phase 3

NULL

1099

NCT01951326
(ClinicalTrials.gov)

September 2013

19/9/2013

Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

A 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

Crohn's Disease

Drug: RHB-104;Drug: Placebo

RedHill Biopharma Limited

NULL

Completed

18 Years

75 Years

All

331

Phase 3

United States;Australia;Bulgaria;Canada;Czechia;Israel;New Zealand;Poland;Serbia;Slovakia;Czech Republic

1100

NCT01958827
(ClinicalTrials.gov)

September 2013

4/10/2013

A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease

Crohn's Disease

Biological: Adalimumab

AbbVie

NULL

Completed

15 Years

N/A

All

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1101

EUCTR2011-001754-28-HR
(EUCTR)

22/08/2013

28/08/2014

A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE

Crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

108

United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1102

EUCTR2013-002932-25-NL
(EUCTR)

21/08/2013

25/07/2013

A randomized clinical trial: treatment of perianal fistulas in Crohn's disease

Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial

Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Academic Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

126

Phase 4

Netherlands

1103

EUCTR2011-003622-27-HR
(EUCTR)

20/08/2013

28/08/2014

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Crohn's Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1104

EUCTR2011-001733-16-HR
(EUCTR)

19/08/2013

28/08/2014

A 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 disease

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE

Product Name: tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1105

EUCTR2013-000971-34-DK
(EUCTR)

01/08/2013

High dose vitamin D treatment in Crohn's disease affects the gut immune cells

Mucosal immune regulation by high dose vitamin D treatment in Crohn’s disease - MirViDiC

Active Crohn's Disease in colon and/or terminal ileum
MedDRA version: 19.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Jørgen Agnholt

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1106

NCT01523106
(ClinicalTrials.gov)

August 2013

18/1/2012

L-carnitine to Treat Fatigue Associated With Crohn's Disease

Crohn's Disease;Fatigue

Drug: L-carnitine;Other: Placebo

University of California, San Francisco

NULL

Withdrawn

18 Years

70 Years

Both

N/A

United States

1107

EUCTR2013-001212-30-NL
(EUCTR)

04/07/2013

18/06/2013

Immune modulation by parenteral Fish oil in patients with Crohn’s disease

Modulation of immune function by parenteral fish oil in patients with Crohn’s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Omegaven
Trade Name: Intralipid 10%

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1108

ChiCTR-DDT-14004999

2013-07-01

2014-07-17

Endoscopic Ultrasonography (EUS) Helps Differentiate Crohn's Disease from Intestinal Tuberculosis

Crohn's disease and intestinal tuberculosis

Gold Standard:;Index test:;

West China Hospital, Sichuan University

NULL

Completed

Both

Target condition:0;Difficult condition:0

China

1109

NCT01915927
(ClinicalTrials.gov)

July 2013

31/7/2013

Stem Cell Fistula Plug in Perianal Crohn's Disease

A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.

Perianal Crohn's Disease

Drug: MSC-AFP

William A. Faubion, M.D.

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

1110

NCT02887287
(ClinicalTrials.gov)

July 2013

29/8/2016

Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment

Drug: EEN

Sun Yat-sen University

NULL

Completed

18 Years

60 Years

Both

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1111

EUCTR2010-022384-35-BG
(EUCTR)

13/06/2013

28/05/2013

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1112

EUCTR2010-022383-12-BG
(EUCTR)

13/06/2013

20/05/2013

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden

1113

EUCTR2011-003622-27-AT
(EUCTR)

04/06/2013

18/03/2013

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1114

EUCTR2011-002817-12-BG
(EUCTR)

03/06/2013

20/05/2013

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand

1115

EUCTR2013-001503-37-DK
(EUCTR)

31/05/2013

06/05/2013

Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease

Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease)
MedDRA version: 14.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Allopurinol
INN or Proposed INN: allopurinol
Other descriptive name: ALLOPURINOL SODIUM

Marianne Kiszka-Kanowitz

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1116

NCT01827631
(ClinicalTrials.gov)

May 27, 2013

5/4/2013

Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

Crohn's Disease

Drug: GSK1605786 capsule

GlaxoSmithKline

NULL

Completed

18 Years

45 Years

All

Phase 1

China

1117

NCT02233062
(ClinicalTrials.gov)

May 2013

1/9/2014

Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease

Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease

Crohn's Disease

Dietary Supplement: Exclusive Enteral Nutrition Therapy

Jinling Hospital, China

NULL

Completed

18 Years

40 Years

Male

N/A

China

1118

NCT02073526
(ClinicalTrials.gov)

May 2013

9/1/2014

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis

Drug: Infliximab , adalimumab, certolizumab pegol

Oslo University Hospital

NULL

Completed

18 Years

N/A

Both

1230

N/A

Norway

1119

EUCTR2012-005226-29-BE
(EUCTR)

26/04/2013

14/03/2013

Antibiotic therapy for children with active Crohn's disease

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole

Wolfson Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Portugal;United States;Canada;Poland;Belgium;Israel;Netherlands

1120

EUCTR2012-002432-93-BG
(EUCTR)

24/04/2013

05/03/2013

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

114

Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria;United States;Serbia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1121

EUCTR2011-002817-12-NL
(EUCTR)

19/04/2013

07/11/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Germany;Norway;Japan;New Zealand;Sweden

1122

EUCTR2012-004098-26-DE
(EUCTR)

17/04/2013

03/01/2013

Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy

1123

EUCTR2012-004098-26-FR
(EUCTR)

10/04/2013

25/09/2015

Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2a

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy

1124

NCT02676622
(ClinicalTrials.gov)

April 2013

21/4/2013

Autologous Stem Cell Transplant for Refractory Crohn's Disease

A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's Disease

Crohn's Disease

Drug: 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 administration

Nationwide Children's Hospital

NULL

Withdrawn

12 Years

29 Years

All

Phase 2

NULL

1125

JPRN-UMIN000010524

2013/03/29

17/04/2013

Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy

Crohn's disease

Adalimubab 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 Gastroenterology

NULL

Complete: follow-up complete

15years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1126

NCT01804166
(ClinicalTrials.gov)

March 21, 2013

1/2/2013

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 Lymphoma

Drug: Infliximab;Drug: Golimumab

Janssen Scientific Affairs, LLC

NULL

Completed

N/A

All

Phase 4

United States

1127

EUCTR2011-002640-27-DE
(EUCTR)

08/03/2013

23/08/2012

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)

A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY

ACTIVE CROHN'S DISEASE
MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0301
Product Code: 40 mg
INN or Proposed INN: NA
Other descriptive name: GED-0301
Product Name: GED-0301
Product Code: 10 mg
INN or Proposed INN: NA
Other descriptive name: GED-0301

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Germany;Italy

1128

NCT01809275
(ClinicalTrials.gov)

March 2013

8/3/2013

Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease

A 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 Disease

Crohn's Disease;Inflammatory Bowel Disease

Drug: QBECO;Drug: Placebo

Qu Biologics Inc.

NULL

Completed

18 Years

N/A

Both

Phase 1;Phase 2

Canada

1129

NCT01810185
(ClinicalTrials.gov)

March 2013

11/3/2013

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis

Drug: Low dose naltrexone;Drug: Placebo

Santa Barbara Cottage Hospital

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

United States

1130

NCT01769755
(ClinicalTrials.gov)

March 2013

15/1/2013

A 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 Disease

A 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 Disease

Crohns Disease

Biological: PDA001;Drug: Vehicle Controlled Placebo

Celularity Incorporated

NULL

Completed

18 Years

75 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1131

NCT01826188
(ClinicalTrials.gov)

March 2013

28/3/2013

Combined THC and CBD Drops for Treatment of Crohn's Disease

Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial

Crohn's Disease

Drug: THC 5mg/ml and CBS 50mg/ml;Drug: Placebo

Meir Medical Center

NULL

Completed

20 Years

85 Years

All

Phase 1;Phase 2

Israel

1132

NCT01828190
(ClinicalTrials.gov)

March 2013

8/4/2013

The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers

Prospective 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 Blockers

Crohn's Disease;Perianal Fistulas

Other: Hyperbaric oxygen

Assaf-Harofeh Medical Center

NULL

Recruiting

18 Years

70 Years

Both

N/A

Israel

1133

EUCTR2012-004098-26-IT
(EUCTR)

25/02/2013

11/01/2013

Evaluation of efficacy and safety of MEDI2070 in patients with active,moderate-to-severe Crohn's disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 inSubjects with Moderate to Severe Crohn's Disease Who Have Failed or AreIntolerant to Anti-tumor Necrosis Factor-alpha Therapy - MEDI 2070

Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: MEDI2070
Product Code: MEDI2070
Other descriptive name: anticorpo monoclonale anti IL-23

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Spain;Germany;Italy;France;United States;Hungary;Czech Republic;Canada

1134

EUCTR2012-002867-86-DK
(EUCTR)

13/02/2013

12/02/2013

Prevention of serious pneumococcal infections in people with Crohn's disease

Pneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease - PneuVac

Crohn's Disease
MedDRA version: 15.1;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Pnemovax
Product Name: Pneumovax
Trade Name: Prevenar 13
Product Name: Prevenar 13

Statens Serum Institut

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

1135

EUCTR2012-004098-26-HU
(EUCTR)

11/02/2013

11/01/2013

Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

France;United States;Czech Republic;Hungary;Canada;Spain;Poland;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1136

EUCTR2012-004098-26-CZ
(EUCTR)

08/02/2013

07/01/2013

Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Product Name: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy

1137

EUCTR2012-002432-93-PL
(EUCTR)

06/02/2013

09/01/2013

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

114

United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Bulgaria

1138

EUCTR2011-002817-12-DE
(EUCTR)

05/02/2013

06/11/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan

1139

NCT01714726
(ClinicalTrials.gov)

February 1, 2013

24/10/2012

Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Crohn's Disease

Drug: MEDI2070;Drug: placebo

Allergan

NULL

Completed

18 Years

65 Years

All

121

Phase 2

United States;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;Czech Republic

1140

NCT01874015
(ClinicalTrials.gov)

February 2013

6/6/2013

Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease

Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease

Crohn's Disease

Biological: mesenchymal cell transplantation;Biological: mesenchymal cell and fibroblast injection

Royan Institute

NULL

Recruiting

18 Years

65 Years

All

Phase 1

Iran, Islamic Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1141

NCT02010762
(ClinicalTrials.gov)

February 2013

10/12/2013

The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease

The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial

Crohn's Disease

Drug: Vitamin D;Drug: Placebo

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

NULL

Completed

18 Years

N/A

All

142

Phase 4

Netherlands

1142

NCT01751152
(ClinicalTrials.gov)

February 2013

13/12/2012

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease

Inflammation;Crohn's Disease

Drug: NNC0114-0006;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Bulgaria;Czech Republic;Poland;Slovakia;Spain;Russian Federation;Serbia

1143

NCT01802593
(ClinicalTrials.gov)

February 2013

24/12/2012

Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure

Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure

Crohn's Disease

Drug: AZATHIOPRINE or METHOTREXATE

Prof. Arie Levine

NULL

Terminated

6 Years

18 Years

Both

Phase 4

Israel

1144

NCT01765998
(ClinicalTrials.gov)

February 2013

6/1/2013

The 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 Inflammation

Crohn's Disease

Drug: Probiotic;Drug: Placebo

The Baruch Padeh Medical Center, Poriya

NULL

Not yet recruiting

18 Years

60 Years

Both

Phase 4

Israel

1145

EUCTR2012-002432-93-SK
(EUCTR)

29/01/2013

28/03/2013

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Crohns disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

114

United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1146

EUCTR2012-004098-26-ES
(EUCTR)

28/01/2013

22/01/2013

Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn´s disease.

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn´s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Crohn´s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: MEDI2070
INN or Proposed INN: Not available
Other descriptive name: Anti-IL-23 monoclonal antibody

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Germany;Italy

1147

EUCTR2012-002432-93-CZ
(EUCTR)

18/01/2013

05/09/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Crohns disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

114

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria

1148

EUCTR2011-002817-12-CZ
(EUCTR)

09/01/2013

08/11/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseRandomizované, dvojite zaslepené klinické hodnocení aktivní lécby pro navození klinické odpovedi a/nebo remise pri podávání GSK1605786A pacientum se stredne težkou až težkou aktivní Crohnovou chorobou.

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand

1149

EUCTR2012-002030-37-BE
(EUCTR)

08/01/2013

05/09/2012

A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Crohn’s Disease (CD) and Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

1150

EUCTR2012-000529-31-NL
(EUCTR)

07/01/2013

22/01/2013

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

United States;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1151

JPRN-UMIN000009596

2013/01/01

21/12/2012

Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).

Crohn`s disease

Withdrawal 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 University

NULL

Complete: follow-up complete

15years-old

Not applicable

Male and Female

200

Not selected

Japan

1152

NCT02501291
(ClinicalTrials.gov)

January 2013

20/5/2015

Thalidomide in Treating Crohn's Disease

Thalidomide in Inducing and Maintaining Remission of Crohn's Disease

Crohn's Disease

Drug: Thalidomide

First Affiliated Hospital, Sun Yat-Sen University

NULL

Completed

18 Years

75 Years

Both

Phase 2

China

1153

EUCTR2011-000722-30-IT
(EUCTR)

30/12/2012

19/12/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-04236921
INN or Proposed INN: PF-04236921
Other descriptive name: IMP will be labeled as PF-04236921 106mg/vial, Clonal SC lyophilized form

PFIZER INC.

NULL

Not Recruiting

Female: yes
Male: yes

180

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Australia;Denmark;New Zealand;Sweden

1154

EUCTR2011-002817-12-DK
(EUCTR)

19/12/2012

30/11/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden

1155

EUCTR2012-000529-31-DE
(EUCTR)

17/12/2012

01/10/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1156

EUCTR2011-002817-12-HU
(EUCTR)

13/12/2012

06/11/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1157

NCT01696396
(ClinicalTrials.gov)

December 4, 2012

27/9/2012

Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: Abrilumab;Drug: Placebo

Amgen

NULL

Completed

18 Years

65 Years

All

254

Phase 2

United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Netherlands;Switzerland;United Kingdom;Czech Republic

1158

NCT01752790
(ClinicalTrials.gov)

December 2012

12/12/2012

Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease

Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial

Pediatric Crohn's Disease

Drug: Top-down;Drug: Step-up

University of Roma La Sapienza

NULL

Withdrawn

6 Years

18 Years

Both

Phase 4

Italy

1159

NCT01078935
(ClinicalTrials.gov)

December 2012

1/3/2010

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

The Effect of Probiotics on Bowel Disease

Crohn's Disease;Ulcerative Colitis

Dietary Supplement: probiotics;Dietary Supplement: placebo

The Baruch Padeh Medical Center, Poriya

Ministry of Health, Israel

Not yet recruiting

18 Years

80 Years

Both

100

Phase 4

NULL

1160

NCT01820247
(ClinicalTrials.gov)

December 2012

25/3/2013

Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission

Crohn's Disease

Drug: enteral nutrition;Drug: Tripterygium glycosides

Zhu Weiming

NULL

Recruiting

18 Years

75 Years

Both

100

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1161

NCT01349920
(ClinicalTrials.gov)

November 28, 2012

5/5/2011

Biomarkers 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 Disease

Drug: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

60 Years

All

Moldova, Republic of;United Kingdom

1162

JPRN-UMIN000009284

2012/11/20

20/11/2012

The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients

The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients - The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease

Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection)

adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week.

Sakura Medical Center,Toho university

NULL

Complete: follow-up complete

18years-old

65years-old

Male and Female

Phase 2

Japan

1163

EUCTR2012-002432-93-ES
(EUCTR)

16/11/2012

02/10/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s disease

Crohns disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

114

United States;Serbia;Hungary;Czech Republic;Slovakia;Poland;Spain;Bulgaria;Russian Federation

1164

EUCTR2011-001754-28-NL
(EUCTR)

15/11/2012

27/12/2011

Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib (CP-690,550)

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

108

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1165

EUCTR2011-001733-16-NL
(EUCTR)

15/11/2012

22/12/2011

Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib (CP-690,550)
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1166

EUCTR2012-000529-31-HU
(EUCTR)

13/11/2012

04/10/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 16.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

France;United States;Czech Republic;Hungary;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom

1167

EUCTR2011-001733-16-CZ
(EUCTR)

12/11/2012

22/12/2011

Crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1168

EUCTR2010-023034-23-CZ
(EUCTR)

12/11/2012

26/06/2012

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Romania;Australia;Denmark;Germany;New Zealand;Sweden

1169

EUCTR2011-000722-30-CZ
(EUCTR)

12/11/2012

21/03/2012

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Crohn’s disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden

1170

EUCTR2011-003622-27-CZ
(EUCTR)

12/11/2012

03/04/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1171

EUCTR2011-001754-28-CZ
(EUCTR)

12/11/2012

15/02/2012

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

108

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1172

EUCTR2012-000529-31-BE
(EUCTR)

09/11/2012

19/09/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom

1173

EUCTR2012-002432-93-HU
(EUCTR)

08/11/2012

25/09/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Crohns disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

114

United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Bulgaria

1174

NCT01817426
(ClinicalTrials.gov)

November 2012

29/8/2012

Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission

Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study

Crohn Disease

Drug: Infliximab;Other: Placebo

Copenhagen University Hospital at Herlev

NULL

Recruiting

18 Years

N/A

Both

136

Phase 4

Denmark

1175

EUCTR2012-000529-31-CZ
(EUCTR)

18/10/2012

21/09/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

United States;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1176

EUCTR2012-000645-13-NL
(EUCTR)

17/10/2012

12/07/2012

Infliximab as first treatment instead of second line treatment in Crohns disease

Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade

ErasmusMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium;Netherlands;Italy

1177

EUCTR2012-000529-31-DK
(EUCTR)

10/10/2012

26/09/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

France;United States;Hungary;Czech Republic;Canada;Belgium;Austria;Denmark;Netherlands;Germany;United Kingdom

1178

EUCTR2012-000529-31-AT
(EUCTR)

09/10/2012

03/10/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom

1179

EUCTR2011-006084-22-GB
(EUCTR)

04/10/2012

15/08/2012

Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment

Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease

Inflammatory bowel disease
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab

Royal Liverpool University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

1180

EUCTR2011-004763-72-NL
(EUCTR)

04/10/2012

30/05/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01

Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Germany;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1181

NCT01823042
(ClinicalTrials.gov)

October 2012

25/3/2013

The 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 Disease

Drug: azathioprine +enteral nutrition;Drug: Azathioprine

Jinling Hospital, China

NULL

Recruiting

18 Years

75 Years

Both

100

N/A

China

1182

NCT01692808
(ClinicalTrials.gov)

October 2012

17/9/2012

Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease

Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease.

Crohn's Disease

Drug: Vitamin D3 3000 UI daily;Drug: Vitamin D3 4000 UI daily

St. Justine's Hospital

NULL

Completed

10 Years

18 Years

Both

Phase 2

Canada

1183

NCT01596894
(ClinicalTrials.gov)

October 2012

12/4/2012

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease

A 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 Disease

Drug: Azithromycin + Metronidazole;Drug: Metronidazole

Prof. Arie Levine

NULL

Completed

5 Years

17 Years

All

Phase 4

Israel

1184

EUCTR2011-006064-43-DE
(EUCTR)

27/09/2012

17/02/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.

A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study.

Perianal fistulising Crohn´s disease
MedDRA version: 17.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix S.A.U.

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy

1185

EUCTR2012-000529-31-GB
(EUCTR)

27/09/2012

21/09/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Moderate to severe Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

252

Phase 2

France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1186

EUCTR2010-024638-48-BG
(EUCTR)

26/09/2012

03/10/2012

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Portugal;United States;Serbia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

1187

EUCTR2012-002702-51-DK
(EUCTR)

24/09/2012

01/08/2012

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima

Department of medical gastroenterology S, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 4

Finland;Denmark;Norway;Sweden

1188

JPRN-UMIN000015297

2012/09/19

01/10/2014

The feasibility study of accelated infliximab infusion from initial administration

The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.

Chiba University Hospital

NULL

Recruiting

20years-old

70years-old

Male and Female

Phase 2

Japan

1189

EUCTR2010-023437-30-BG
(EUCTR)

18/09/2012

17/07/2012

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

1190

EUCTR2011-006064-43-IT
(EUCTR)

13/09/2012

05/03/2012

Study 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. ADMIRE-CD study. - ADIMIRE-CD study

Perianal fistulising Crohn's disease
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601
Product Code: Cx601
INN or Proposed INN: NA
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs)

CELLERIX S.A.

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1191

EUCTR2011-004763-72-GB
(EUCTR)

13/09/2012

25/06/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb
Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

United States;Taiwan;Hong Kong;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of

1192

NCT01632462
(ClinicalTrials.gov)

September 2012

25/6/2012

A 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 Disease

Crohn's Disease

Drug: VSL#3

Federico II University

NULL

Recruiting

5 Years

17 Years

Both

Phase 4

Italy

1193

EUCTR2011-003622-27-DE
(EUCTR)

20/08/2012

30/03/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE -

Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;France;Netherlands Antilles;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1194

EUCTR2011-000854-44-LV
(EUCTR)

10/08/2012

19/06/2012

A clinical study for treatment of Crohns Disease with the new drug substance TRK-170. The study consists of two parts and are conducted at servral hopsitals in Europe. Patients in the study may receive placebo (drug with no effect) but either the doctor or the patient will know during the study.

A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn’s Disease

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

510

Czech Republic;Hungary;Poland;Bulgaria;Norway;Latvia;Sweden

1195

NCT03079700
(ClinicalTrials.gov)

August 1, 2012

9/3/2017

Immune Modulation From Trichuris Suis

Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual

Crohn Disease;Ulcerative Colitis;Intestinal Helminthiasis

Biological: Trichuris suis eggs

University of Aarhus

NULL

Completed

18 Years

70 Years

Male

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1196

EUCTR2011-005886-19-DK
(EUCTR)

31/07/2012

Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST)

Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) - CONTRAST

Crohns Disease with active disease
MedDRA version: 14.1;Level: PT;Classification code 10059696;Term: Scan with contrast;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10028049;Term: MRI;Classification code 10045434;Term: Ultrasound scan;System Organ Class: 10022891 - Investigations;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trade Name: SonoVue
INN or Proposed INN: sulphur hexafluoride
Other descriptive name: SULFUR HEXAFLUORIDE

Gastroenterology MIDT

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

1197

EUCTR2011-005846-36-DK
(EUCTR)

31/07/2012

Bloodflow measurements in stenotic inflammatory bowel disease.

Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS) - STENOSIS

Crohns Disease undergoing elective surgery for intestinal stenosis.
MedDRA version: 14.1;Level: PT;Classification code 10058829;Term: Elective surgery;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1;Classification code 10059696;Term: Scan with contrast;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10028049;Term: MRI;Classification code 10045434;Term: Ultrasound scan;Classification code 10022699;Term: Intestinal stenosis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trade Name: SonoVue
INN or Proposed INN: sulphur hexafluoride
Other descriptive name: SULFUR HEXAFLUORIDE

Gastroenterology MIDT

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

1198

EUCTR2011-002517-11-BG
(EUCTR)

18/07/2012

27/06/2012

The 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 placebo

A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab

Moderate to severe Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab

UCB BIOSCIENCES GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Serbia;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany

1199

EUCTR2011-004763-72-IT
(EUCTR)

16/07/2012

03/09/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Crohn’s Disease
MedDRA version: 15.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
Other descriptive name: anti-IL-6 mAb

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;India;Czech Republic;Hungary;European Union;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of

1200

EUCTR2011-004763-72-CZ
(EUCTR)

11/07/2012

21/05/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1201

EUCTR2011-003622-27-BG
(EUCTR)

11/07/2012

19/05/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Crohn's Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1202

EUCTR2010-022382-10-AT
(EUCTR)

10/07/2012

24/04/2012

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden

1203

EUCTR2011-004763-72-DE
(EUCTR)

04/07/2012

27/04/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

1204

EUCTR2011-006064-43-NL
(EUCTR)

03/07/2012

05/07/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease.

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study

Perianal fistulising Crohn´s disease
MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: Not applicable
Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A. Unipersonal

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

208

Phase 3

France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy

1205

NCT01576471
(ClinicalTrials.gov)

July 2012

10/4/2012

Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo

A 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 Disease

Crohn's Disease

Biological: Trichuris suis ova (TSO);Biological: Placebo

Coronado Biosciences, Inc.

NULL

Completed

18 Years

65 Years

All

250

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1206

EUCTR2011-004763-72-HU
(EUCTR)

26/06/2012

26/04/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

1207

NCT00692939
(ClinicalTrials.gov)

June 26, 2012

3/6/2008

Autologous Stem Cell Transplantation for Crohn's Disease

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease

Crohn's Disease

Biological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: Mesna

Paul Szabolcs

NULL

Recruiting

10 Years

60 Years

All

Phase 1;Phase 2

United States

1208

EUCTR2011-006064-43-BE
(EUCTR)

22/06/2012

21/02/2012

Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease.

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study.

Perianal fistulising Crohn´s desease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Allogenic eASCs 5 million/ml suspension for injection.
Product Code: Cx601
INN or Proposed INN: N/A
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

TiGenix, S.A. Unipersonal

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy

1209

EUCTR2011-003038-14-NL
(EUCTR)

21/06/2012

31/05/2012

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX

Luminal active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Netherlands

1210

EUCTR2010-022382-10-ES
(EUCTR)

20/06/2012

11/05/2012

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn's Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn's Disease

Subjects with Moderately-to-Severely Active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Hungary;Germany;Netherlands;France;Norway;Italy;Austria;South Africa;Sweden;Australia;Israel;Czech Republic;Slovakia;United Kingdom;New Zealand;Canada;Denmark;Belgium;Korea, Republic of;Spain;Japan;United States;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1211

EUCTR2012-000729-28-ES
(EUCTR)

13/06/2012

17/04/2012

Imaging study in patients with Crohn`s Disease

MULTICENTER STUDY IN PATIENTS WITH CROHN?S DISEASE FOR CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY ASSAYS FOR ASSESSMENT OF DISEASE ACTIVITY

Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease
MedDRA version: 14.1;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Product Name: /
Product Code: /
INN or Proposed INN: ÁCIDO GADOBÉNICO
Other descriptive name: NA

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium;France;Spain;United States

1212

EUCTR2011-004820-37-ES
(EUCTR)

13/06/2012

15/02/2012

Experimental study in humans to evaluate the efficacy and safety of bloodproducts rich in proteins for the treatment of anal fistulas in Crohn'spatients

Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients

Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
Other descriptive name: HUMAN PLASMA FOR FRACTIONATION

Fundación FISEVI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain

1213

EUCTR2009-017998-37-BE
(EUCTR)

08/06/2012

11/04/2012

Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Ghent University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Belgium

1214

EUCTR2011-003622-27-SE
(EUCTR)

07/06/2012

09/02/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Product Code: CP -690,550-10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden

1215

EUCTR2010-023437-30-PL
(EUCTR)

06/06/2012

08/05/2012

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1216

EUCTR2011-001754-28-DE
(EUCTR)

05/06/2012

17/10/2011

Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

108

Phase 2

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1217

EUCTR2011-003622-27-GR
(EUCTR)

05/06/2012

24/05/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Product Code: CP -690,550-10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden

1218

EUCTR2011-006127-38-ES
(EUCTR)

05/06/2012

15/02/2012

Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment.

Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot in processed with PRGF-system technology, in the treatment of anal fistulas in Crohn's patients with no concomitant therapy with second-line drugs.

Perianal fistulas in Crohn's Disease Patients
MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Fundación FISEVI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain

1219

EUCTR2010-024638-48-PL
(EUCTR)

04/06/2012

09/05/2012

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Crohn’s disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

1220

EUCTR2011-000854-44-BG
(EUCTR)

01/06/2012

07/05/2012

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat several hospitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease

Product Name: TRK-170
Product Code: TRK-170
INN or Proposed INN: Not available
Product Name: TRK-170
Product Code: TRK-170
INN or Proposed INN: Not available

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

510

Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1221

JPRN-UMIN000007806

2012/06/01

01/05/2012

The feasibility study of accelated infliximab infusion during maintenance phase

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Complete: follow-up complete

Not applicable

Male and Female

Phase 2

Japan

1222

JPRN-UMIN000008199

2012/06/01

19/06/2012

The 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 months

Patients administered with mosapride
Patients administered with no mosapride

Department of Gastroenterology, Graduate School of Medicine, Osaka City University

NULL

Complete: follow-up complete

12years-old

85years-old

Male and Female

Not selected

Japan

1223

NCT01624376
(ClinicalTrials.gov)

June 2012

14/6/2012

Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease

A 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 Disease

Drug: DLX105;Drug: Placebo

Delenex Therapeutics AG

NULL

Completed

18 Years

65 Years

Both

Phase 2

Switzerland

1224

NCT01442025
(ClinicalTrials.gov)

June 2012

20/9/2011

Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease

Crohn's Disease

Drug: Infliximab

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Completed

18 Years

N/A

Both

121

Phase 4

France

1225

NCT01545050
(ClinicalTrials.gov)

June 2012

1/3/2012

Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Biological: Placebo matching with BMS-945429;Biological: BMS-945429

CSL Behring

NULL

Terminated

18 Years

N/A

All

Phase 2

United States;Austria;Canada;Czechia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Switzerland;Taiwan;United Kingdom;Australia;Brazil;Czech Republic;Russian Federation;Singapore

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1226

NCT01635621
(ClinicalTrials.gov)

June 2012

3/7/2012

A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Olokizumab Administered Subcutaneously to Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: Olokizumab (OKZ);Drug: Placebo

UCB BIOSCIENCES GmbH

NULL

Withdrawn

18 Years

65 Years

Both

Phase 2

Bulgaria;Czech Republic;Germany;Hungary;Poland

1227

NCT01181765
(ClinicalTrials.gov)

June 2012

12/8/2010

The 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 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 Disease

Biological: Infliximab 5 mg/kg body weight infused over 2 hours

Janssen Inc.

NULL

Completed

18 Years

N/A

Both

Phase 4

Canada

1228

EUCTR2011-001754-28-BG
(EUCTR)

29/05/2012

07/05/2012

Crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

108

United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1229

EUCTR2011-001733-16-BG
(EUCTR)

29/05/2012

30/03/2012

Crohn's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1230

EUCTR2011-004763-72-AT
(EUCTR)

25/05/2012

27/04/2012

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody
Other descriptive name: anti-IL-6 mAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1231

EUCTR2010-022382-10-SK
(EUCTR)

22/05/2012

12/04/2012

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

600

1232

EUCTR2010-022384-35-SK
(EUCTR)

16/05/2012

13/04/2012

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1233

EUCTR2011-006064-43-AT
(EUCTR)

15/05/2012

05/03/2012

Study 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.

Perianal fistulising Crohn´s disease
MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TiGenix, S.A.U.

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 3

France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy

1234

EUCTR2011-003622-27-HU
(EUCTR)

10/05/2012

21/03/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Ukraine;United States;Greece;Spain;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1235

JPRN-UMIN000009631

2012/05/02

26/12/2012

Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled study

Crohn's disease

In 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 University

NULL

Recruiting

16years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1236

JPRN-UMIN000008043

2012/05/01

28/05/2012

The influence of medication for Crohn's disease on serological response to the influenza vaccination

The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination

Crohn's disease

Influenza Vaccination to Crohn's disease patients treated with Infliximab

Influenza Vaccination to Crohn's disease patients treated with Elemental diet
Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)

The Jikei University School of MedicineDivision of Gastroenterology and Hepatology

NULL

Complete: follow-up complete

16years-old

60years-old

Male and Female

150

Phase 4

Japan

1237

NCT01387594
(ClinicalTrials.gov)

May 2012

30/6/2011

Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs

A 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 Colitis

Procedure: lumbar puncture;Drug: lumbar puncture

Shire

NULL

Completed

18 Years

75 Years

All

Phase 1

Austria;Belgium;France;Germany;Netherlands

1238

EUCTR2011-002517-11-CZ
(EUCTR)

23/04/2012

25/01/2012

The 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 placebo

Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab

UCB BIOSCIENCES GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Czech Republic;Germany

1239

EUCTR2011-002817-12-SK
(EUCTR)

19/04/2012

13/04/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Germany;France;Hong Kong;Austria;Sweden;South Africa;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Hungary;Switzerland;Netherlands;Chile;Norway;Italy;Israel;United Kingdom;Russian Federation;Slovakia;Ukraine;Taiwan;Denmark;Argentina;Estonia;China;Spain;Japan

1240

EUCTR2011-003622-27-ES
(EUCTR)

17/04/2012

16/02/2012

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASE

Product Code: CP -690,550-10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1241

EUCTR2010-022758-18-BE
(EUCTR)

16/04/2012

07/06/2011

Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1

Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of

1242

EUCTR2010-022760-12-BE
(EUCTR)

16/04/2012

07/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

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 Disease - IMUNITI

Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan

1243

EUCTR2011-000722-30-GB
(EUCTR)

12/04/2012

06/05/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Crohn’s disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

1244

EUCTR2011-001733-16-DE
(EUCTR)

10/04/2012

18/10/2011

Product Name: tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1245

EUCTR2010-023589-39-DE
(EUCTR)

10/04/2012

16/05/2011

A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)

A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD

Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: ST10-021
Product Code: ST10-021
Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1246

EUCTR2011-000854-44-CZ
(EUCTR)

04/04/2012

12/01/2012

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

510

Hungary;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden

1247

EUCTR2010-022760-12-NL
(EUCTR)

04/04/2012

13/07/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan

1248

EUCTR2011-001754-28-GR
(EUCTR)

02/04/2012

16/02/2012

Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CP -690,550-10

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

108

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

1249

NCT01470599
(ClinicalTrials.gov)

April 2012

27/10/2011

A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

Crohn's Disease

Drug: CP -690,550

Pfizer

NULL

Completed

18 Years

76 Years

All

150

Phase 2

United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;Czech Republic

1250

NCT01877577
(ClinicalTrials.gov)

April 2012

11/6/2013

Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

Supplementation 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 D3

University of California, San Francisco

NULL

Completed

18 Years

N/A

Both

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1251

EUCTR2011-003038-14-BE
(EUCTR)

30/03/2012

03/01/2012

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX

Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Belgium;Netherlands

1252

EUCTR2011-002817-12-PT
(EUCTR)

29/03/2012

18/01/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1253

EUCTR2010-022383-12-PT
(EUCTR)

29/03/2012

18/01/2012

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1254

EUCTR2010-022384-35-PT
(EUCTR)

29/03/2012

18/01/2012

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

1255

EUCTR2010-022384-35-IT
(EUCTR)

28/03/2012

02/03/2012

A 25 month study of a potential new medicine (GSK1605786A) for thetreatment of Crohn's disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A inSubjects with Crohn's Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Portugal;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1256

EUCTR2010-022383-12-IT
(EUCTR)

28/03/2012

02/03/2012

A 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

NULL

Not Recruiting

Female: yes
Male: yes

750

Portugal;United States;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Japan;Sweden

1257

EUCTR2010-022382-10-IT
(EUCTR)

28/03/2012

02/03/2012

A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to-Severely Active Crohn's Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to Severely Active Crohn's Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: NA
Other descriptive name: NA

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Spain;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;South Africa;Norway;Germany;Netherlands;Japan;New Zealand;Sweden

1258

EUCTR2010-022383-12-ES
(EUCTR)

27/03/2012

11/01/2012

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

1259

EUCTR2011-002817-12-ES
(EUCTR)

27/03/2012

11/01/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's Disease

Moderately-to-Severely Active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

1260

EUCTR2010-022384-35-ES
(EUCTR)

27/03/2012

11/01/2012

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn's disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn's Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1261

EUCTR2011-002517-11-HU
(EUCTR)

26/03/2012

09/01/2012

The 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 placebo

Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab

UCB BIOSCIENCES GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Czech Republic;Hungary;Germany

1262

EUCTR2011-002981-19-PL
(EUCTR)

21/03/2012

12/01/2012

Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease

A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease.Revised Protocol 043 incorporating Protocol Amendment 05Pharmacogenetics Blood Sample Amendment 01

CROHN’S DISEASE
MedDRA version: 16.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.1;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2a

United States;France;Hungary;Belgium;Poland;South Africa

1263

EUCTR2010-024638-48-BE
(EUCTR)

19/03/2012

25/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

1264

EUCTR2010-022384-35-AT
(EUCTR)

13/03/2012

27/12/2011

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;New Zealand;Sweden

1265

EUCTR2010-023034-23-BE
(EUCTR)

12/03/2012

05/09/2011

A 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 Responsers

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1266

EUCTR2011-000722-30-BE
(EUCTR)

12/03/2012

05/09/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

160

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden

1267

EUCTR2011-005966-39-BE
(EUCTR)

08/03/2012

12/12/2011

Therapeutic effect of mesenchymal cells in patients suffering from a disease characterized by a severe inflammation and/or in whom the immune system attacks their own tissues.

Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders.

Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.0;Level: PT;Classification code 10064147;Term: Gastrointestinal inflammation;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: mesenchymal stem cells
Product Code: MSC

CHU-ULg

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

1268

EUCTR2010-022383-12-SK
(EUCTR)

07/03/2012

12/04/2012

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

1269

EUCTR2011-002981-19-HU
(EUCTR)

06/03/2012

27/12/2011

Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease

A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01

CROHN’S DISEASE
MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2a

France;United States;Hungary;Belgium;Poland;South Africa

1270

EUCTR2010-022384-35-EE
(EUCTR)

01/03/2012

06/02/2012

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A
Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1271

EUCTR2010-022383-12-EE
(EUCTR)

01/03/2012

06/02/2012

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

1272

EUCTR2011-002817-12-EE
(EUCTR)

01/03/2012

06/02/2012

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

Greece;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand

1273

NCT01580670
(ClinicalTrials.gov)

March 2012

3/4/2012

Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease

Pediatric Crohn's Disease

Drug: TA-650

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

6 Years

17 Years

All

Phase 3

Japan

1274

NCT01647412
(ClinicalTrials.gov)

March 2012

19/7/2012

Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease

Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial

Crohn's Disease

Drug: Growth Hormone;Dietary Supplement: Nutraceutical Combination;Other: Exclusion Diet;Other: Placebo Growth Hormone

Columbia University

NULL

Withdrawn

10 Years

17 Years

Both

Phase 2

United States

1275

NCT01393899
(ClinicalTrials.gov)

March 2012

12/7/2011

The Safety And Efficacy Of Maintenance Therapy With CP-690,550

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease

Crohn's Disease

Drug: Placebo;Drug: CP -690,550

Pfizer

NULL

Completed

18 Years

75 Years

All

180

Phase 2

United States;Australia;Austria;Bulgaria;Canada;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1276

NCT01540292
(ClinicalTrials.gov)

March 2012

22/2/2012

Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders

Crohn's Disease

Biological: Mesenchymal Stem Cells (MSC)

University Hospital of Liege

NULL

Recruiting

18 Years

75 Years

Both

Phase 1;Phase 2

Belgium

1277

NCT02450513
(ClinicalTrials.gov)

March 2012

12/5/2015

Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

Crohn's Disease

Drug: Adalimumab

Universitaire Ziekenhuizen Leuven

NULL

Recruiting

18 Years

65 Years

Both

N/A

Belgium

1278

EUCTR2011-002517-11-DE
(EUCTR)

22/02/2012

02/11/2011

The 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 placebo

Moderate to severe Crohn’s disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 15.0;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: olokizumab
Product Code: CDP6038
INN or Proposed INN: olokizumab

UCB BIOSCIENCES GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Czech Republic;Hungary;Germany

1279

EUCTR2010-024638-48-DE
(EUCTR)

22/02/2012

30/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

1280

EUCTR2010-022384-35-PL
(EUCTR)

15/02/2012

11/01/2012

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1281

EUCTR2010-022383-12-PL
(EUCTR)

15/02/2012

11/01/2012

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

1282

EUCTR2011-002981-19-BE
(EUCTR)

14/02/2012

14/12/2011

Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease

A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2a

France;United States;Hungary;Poland;Belgium;South Africa

1283

EUCTR2011-001754-28-ES
(EUCTR)

02/02/2012

07/12/2011

Crohn's disease
MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CP -690,550-10

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

108

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

1284

JPRN-UMIN000007343

2012/02/01

21/02/2012

The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients

The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients

Crohn's disease

Patients 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)

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

1285

NCT01514240
(ClinicalTrials.gov)

February 2012

10/1/2012

Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

A 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 Japan

Crohn's Disease

Drug: D9421-C capsule 3 mg;Drug: Mesalazine tablets

AstraZeneca

NULL

Completed

15 Years

130 Years

All

123

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1286

NCT02399683
(ClinicalTrials.gov)

February 2012

12/3/2015

Immune Modulation From Trichuris Trichiura

Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual

Crohn Disease;Colitis, Ulcerative;Intestinal Helminthiasis

Biological: Trichuris trichiura eggs

University of Aarhus

NULL

Completed

18 Years

70 Years

Male

N/A

NULL

1287

EUCTR2010-024638-48-NO
(EUCTR)

31/01/2012

01/06/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Portugal;Serbia;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden

1288

EUCTR2010-022383-12-AT
(EUCTR)

26/01/2012

29/12/2011

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;Denmark;Australia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden

1289

EUCTR2011-001733-16-AT
(EUCTR)

26/01/2012

21/12/2011

Product Name: tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1290

EUCTR2011-002817-12-AT
(EUCTR)

26/01/2012

28/12/2011

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1291

EUCTR2011-001754-28-AT
(EUCTR)

26/01/2012

21/12/2011

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

108

United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1292

EUCTR2011-001733-16-HU
(EUCTR)

24/01/2012

14/11/2011

Product Name: tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Norway;Germany;Japan;Korea, Republic of;Sweden

1293

EUCTR2011-005678-47-IT
(EUCTR)

19/01/2012

21/12/2011

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.

CROHN'S DISEASE IN REMISSION PHASE
MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0301
Product Code: NA

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Italy

1294

EUCTR2010-020137-10-HU
(EUCTR)

12/01/2012

22/11/2011

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden

1295

EUCTR2011-003966-34-ES
(EUCTR)

10/01/2012

13/10/2011

Biomarkers in diagnosis & treatment of patients with Crohn?s disease treated with immunosuppressants

The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn?s disease treated with immunosuppressants - not applicable

Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)

NULL

Not Recruiting

Female: yes
Male: yes

180

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1296

EUCTR2011-001754-28-HU
(EUCTR)

10/01/2012

17/11/2011

Product Name: Tofacitinib
Product Code: CP -690,550-10
Other descriptive name: Tofacitinib

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

108

United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of

1297

EUCTR2010-022383-12-GR
(EUCTR)

09/01/2012

14/12/2011

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

United States;Portugal;Estonia;Hong Kong;Taiwan;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1298

EUCTR2011-001733-16-GR
(EUCTR)

09/01/2012

14/12/2011

Product Code: CP -690,550-10

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

1299

EUCTR2011-002817-12-GR
(EUCTR)

09/01/2012

14/12/2011

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research and Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

900

1300

EUCTR2010-022384-35-GR
(EUCTR)

09/01/2012

27/12/2011

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1301

JPRN-UMIN000007514

2012/01/01

15/03/2012

Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence

Crohn's disease

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.

Nagoya University Gradeate School of MedicineDepartment of Gastroenterology

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Phase 2

Japan

1302

JPRN-UMIN000006889

2012/01/01

01/01/2012

Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy

Crohn's disease

Repeat 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 Medicine

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

Phase 4

Japan

1303

EUCTR2011-000885-36-ES
(EUCTR)

26/12/2011

29/11/2011

Adalimub treatment to prevent recurrency post-surgery in Crohn disease.

Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment - APPRECIA

Compare efficay of Adalimub vs Azatioprina to prevent surgical intervention in Chron disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Other descriptive name: Adalimumab
Trade Name: Imurel
Product Name: Imurel
INN or Proposed INN: Azatioprina
Other descriptive name: Imurel
Trade Name: Flagyl
Product Name: Flagyl
INN or Proposed INN: Metronidazol
Other descriptive name: Flagyl

GETECCU

NULL

Not Recruiting

Female: yes
Male: yes

Spain

1304

EUCTR2011-001733-16-ES
(EUCTR)

23/12/2011

28/10/2011

Product Code: CP -690,550-10

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

1305

EUCTR2010-022759-42-IS
(EUCTR)

22/12/2011

29/10/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Iceland;New Zealand;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1306

EUCTR2010-022382-10-HU
(EUCTR)

14/12/2011

11/10/2011

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Japan;Sweden

1307

EUCTR2008-005237-30-SE
(EUCTR)

14/12/2011

16/08/2011

A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease

A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP

Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

4000

Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Italy;United States;Sweden

1308

EUCTR2011-001754-28-SE
(EUCTR)

14/12/2011

19/10/2011

Product Code: CP -690,550-10

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

108

United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Australia;South Africa;Croatia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

1309

EUCTR2010-022384-35-HU
(EUCTR)

14/12/2011

11/10/2011

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden

1310

EUCTR2010-022760-12-BG
(EUCTR)

14/12/2011

11/11/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

Brazil;Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1311

EUCTR2011-000722-30-HU
(EUCTR)

14/12/2011

21/10/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Product Name: Not Applicable
Product Code: PF-04236921
INN or Proposed INN: Not Applicable
Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA.

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden

1312

EUCTR2010-022383-12-HU
(EUCTR)

14/12/2011

11/10/2011

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden

1313

EUCTR2011-003966-34-BE
(EUCTR)

06/12/2011

11/10/2011

Biomarkers in diagnosis & treatment of patients with Crohn’s disease treated with immunosuppressants

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Spain;Belgium

1314

EUCTR2010-022759-42-BG
(EUCTR)

02/12/2011

11/11/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

612

Phase 3

United 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

1315

EUCTR2010-023437-30-NO
(EUCTR)

01/12/2011

01/06/2011

Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA

Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Portugal;Germany;Netherlands;Norway;France;Austria;South Africa;Sweden;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1316

EUCTR2011-003743-22-IT
(EUCTR)

01/12/2011

08/03/2012

A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Trade Name: Entocort
INN or Proposed INN: BUDESONIDE

ASTRAZENECA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

110

United States;Canada;Germany;Italy

1317

EUCTR2010-022759-42-NL
(EUCTR)

01/12/2011

13/07/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

612

Phase 3

United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Germany;Netherlands;Japan;New Zealand;Korea, Republic of

1318

NCT01991314
(ClinicalTrials.gov)

December 2011

18/11/2013

Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate

Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue

Ulcerative Colitis;Crohn's Disease

Drug: Ferrous sulphate

Queen Mary University of London

NULL

Completed

13 Years

80 Years

All

Phase 4

United Kingdom

1319

NCT01453946
(ClinicalTrials.gov)

December 2011

14/10/2011

Safety and Maintenance Study of Entocort for Children With Crohn's Disease

A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Crohn's Disease

Drug: Entocort

Perrigo Company

NULL

Completed

5 Years

17 Years

All

Phase 3

United States;Canada;Germany;Italy;Poland

1320

NCT01466374
(ClinicalTrials.gov)

December 2011

3/11/2011

Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

Crohn's Disease

Drug: Placebo;Drug: BMS-936557 (Anti-IP-10 Antibody)

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

121

Phase 2

United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1321

EUCTR2010-023034-23-DE
(EUCTR)

21/11/2011

14/07/2011

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers

Crohn's Disease (active moderate to severe)
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden

1322

EUCTR2011-001733-16-SE
(EUCTR)

17/11/2011

19/10/2011

Product Code: CP -690,550-10

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

275

1323

EUCTR2010-023437-30-DE
(EUCTR)

16/11/2011

26/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

1324

NCT01536418
(ClinicalTrials.gov)

November 11, 2011

16/2/2012

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease

Crohn's Disease

Drug: GSK1605786A

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

255

Phase 3

United 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

1325

EUCTR2010-024638-48-NL
(EUCTR)

11/11/2011

08/06/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Canada;Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1326

EUCTR2010-023437-30-NL
(EUCTR)

11/11/2011

08/06/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's Disease

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden

1327

EUCTR2011-000854-44-PL
(EUCTR)

09/11/2011

12/08/2011

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

510

Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Sweden

1328

EUCTR2011-000722-30-IE
(EUCTR)

02/11/2011

13/05/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden

1329

JPRN-UMIN000007047

2011/11/01

10/01/2012

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease - Effect of adacolumn and adalimumab combination therapy for Crohn's disease

Crohn's disease

Adacolumn 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 Hepatology

NULL

Complete: follow-up complete

12years-old

75years-old

Male and Female

Not applicable

Japan

1330

NCT01218360
(ClinicalTrials.gov)

November 2011

7/10/2010

Observational 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 Disease

Drug: Physician standard-of-care

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

Both

N/A

Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1331

NCT01444092
(ClinicalTrials.gov)

November 2011

28/9/2011

Safety Study of Entocort for Children With Crohn's Disease

A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Crohn's Disease

Drug: Entocort

Perrigo Company

NULL

Completed

5 Years

17 Years

All

123

Phase 3

United States;Canada;Germany;Italy;Poland

1332

NCT01540942
(ClinicalTrials.gov)

November 2011

23/2/2012

Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease

A 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 Disease

Crohn's Disease

Dietary Supplement: nutrition treat;Other: surgery

Jinling Hospital, China

NULL

Completed

18 Years

75 Years

Both

N/A

China

1333

NCT01442363
(ClinicalTrials.gov)

November 2011

26/9/2011

A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease

Perianal Crohn's Disease

Drug: BLI-1300 low dose;Drug: BLI-1300 high dose;Drug: placebo

Braintree Laboratories

NULL

Terminated

18 Years

N/A

Both

Phase 2

United States

1334

NCT01434693
(ClinicalTrials.gov)

November 2011

13/9/2011

Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

A 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 Disease

Crohn's Disease

Biological: Trichuris suis ova;Other: Placebo

Coronado Biosciences, Inc.

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

1335

EUCTR2011-000722-30-DK
(EUCTR)

25/10/2011

17/10/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1336

EUCTR2011-000722-30-GR
(EUCTR)

24/10/2011

19/08/2011

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003

A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II

Crohn’s disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden

1337

EUCTR2010-022760-12-GB
(EUCTR)

21/10/2011

02/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

1338

EUCTR2010-023034-23-IT
(EUCTR)

21/10/2011

29/12/2011

A 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

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS(ANDANTE) - ANDANTE

Crohn's Disease (active moderate to severe)
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-04236921
INN or Proposed INN: PF-04236921
Other descriptive name: IMP will be labeled as ''PF-04236921 106mg/vial, Clonal SC lyophilized form''.

PFIZER INC.

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Greece;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden

1339

EUCTR2010-022759-42-GB
(EUCTR)

21/10/2011

02/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

612

Phase 3

United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of

1340

EUCTR2010-022758-18-GB
(EUCTR)

21/10/2011

02/06/2011

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1341

EUCTR2010-022760-12-IE
(EUCTR)

17/10/2011

08/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

1342

EUCTR2010-022758-18-IE
(EUCTR)

17/10/2011

08/06/2011

Moderately to severely active Crohn's disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of

1343

EUCTR2010-022760-12-FR
(EUCTR)

13/10/2011

23/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1275

Phase 3

1344

JPRN-UMIN000006232

2011/10/01

01/09/2011

Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab

Crohn's disease

treatment 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 University

NULL

Complete: follow-up complete

15years-old

70years-old

Male and Female

Not selected

Japan

1345

NCT01393626
(ClinicalTrials.gov)

October 2011

11/7/2011

A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: Placebo;Drug: CP -690,550

Pfizer

NULL

Completed

18 Years

75 Years

All

280

Phase 2

United 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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1346

NCT01433432
(ClinicalTrials.gov)

October 2011

12/9/2011

Open Label Extension Study to Protocol C2/13/DR-6MP-02

Clinical 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 Study

Crohn's Disease

Drug: 80 mg DR-6MP

Teva GTC

NULL

Withdrawn

18 Years

75 Years

Both

Phase 2

Israel

1347

EUCTR2010-024638-48-SK
(EUCTR)

29/09/2011

11/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

1348

EUCTR2010-023437-30-SK
(EUCTR)

29/09/2011

11/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Norway;Germany;Korea, Republic of;Sweden

1349

EUCTR2010-023034-23-HU
(EUCTR)

20/09/2011

10/06/2011

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

1350

NCT01489943
(ClinicalTrials.gov)

September 19, 2011

1/12/2011

A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects

A 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 Subjects

Crohn's Disease

Drug: GSK1605786 500 mg;Drug: Midazolam 3 mg;Drug: Pioglitazone 15 mg;Drug: Omeprazole 40 mg;Drug: Rosuvastatin 10 mg

GlaxoSmithKline

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1351

EUCTR2010-023034-23-GB
(EUCTR)

15/09/2011

16/06/2011

A 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 Responsers

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden

1352

NCT01369355
(ClinicalTrials.gov)

September 13, 2011

7/6/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

Crohn's Disease;Colitis;IBD;Inflammatory Bowel Disease

Drug: Placebo SC;Drug: Placebo IV;Drug: Ustekinumab 90 mg SC q8w;Drug: Ustekinumab 130 mg IV;Drug: Ustekinumab 90 mg SC q12w

Janssen Research & Development, LLC

NULL

Completed

18 Years

99 Years

All

1282

Phase 3

United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Czech Republic

1353

EUCTR2010-022760-12-DE
(EUCTR)

13/09/2011

26/05/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1310

Phase 3

United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan

1354

EUCTR2010-022759-42-ES
(EUCTR)

13/09/2011

27/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of

1355

EUCTR2011-000854-44-HU
(EUCTR)

06/09/2011

02/06/2011

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

609

Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1356

EUCTR2010-024638-48-PT
(EUCTR)

02/09/2011

26/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

210

Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

1357

EUCTR2010-022760-12-ES
(EUCTR)

02/09/2011

03/11/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn?s Disease

Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1275

Phase 3

1358

EUCTR2010-023437-30-PT
(EUCTR)

02/09/2011

26/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden

1359

JPRN-UMIN000005689

2011/09/01

31/05/2011

GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial

Crohn's disease

Patients 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 Hospital

NULL

Complete: follow-up complete

12years-old

75years-old

Male and Female

Not applicable

Japan

1360

EUCTR2010-022758-18-ES
(EUCTR)

01/09/2011

22/06/2011

Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Hungary;Germany;European Union;Ireland;Italy;Austria;South Africa;Australia;Brazil;Israel;Czech Republic;United Kingdom;New Zealand;Serbia;Canada;Iceland;Denmark;Belgium;Korea, Republic of;Spain;Japan;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1361

EUCTR2010-023034-23-DK
(EUCTR)

30/08/2011

11/07/2011

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers

Crohn's Disease (active moderate to severe)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden

1362

EUCTR2010-022759-42-DE
(EUCTR)

29/08/2011

26/05/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

612

Phase 3

1363

EUCTR2010-022758-18-DE
(EUCTR)

24/08/2011

26/05/2011

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

1364

EUCTR2010-022758-18-CZ
(EUCTR)

22/08/2011

08/06/2011

Moderately to severely active Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

1365

EUCTR2010-022760-12-CZ
(EUCTR)

17/08/2011

08/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1366

EUCTR2010-022760-12-DK
(EUCTR)

15/08/2011

26/08/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

1367

EUCTR2010-022758-18-DK
(EUCTR)

15/08/2011

25/07/2011

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

1368

EUCTR2010-023797-39-GB
(EUCTR)

12/08/2011

16/07/2011

TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE

TREATMENT 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.

Barts Health NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

1369

EUCTR2010-022759-42-HU
(EUCTR)

09/08/2011

10/08/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

612

Phase 3

1370

EUCTR2010-022760-12-IT
(EUCTR)

09/08/2011

30/03/2012

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1371

EUCTR2010-022759-42-IT
(EUCTR)

09/08/2011

23/01/2012

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB

JANSSEN-CILAG INTERNATIONAL N.V.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Spain;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of

1372

EUCTR2010-022758-18-IT
(EUCTR)

09/08/2011

22/06/2012

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB

JANSSEN-CILAG INTERNATIONAL N.V.

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of

1373

EUCTR2010-022760-12-HU
(EUCTR)

09/08/2011

08/07/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan

1374

EUCTR2010-018431-18-CZ
(EUCTR)

08/08/2011

19/05/2011

A 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 Recurrence

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT

Crohn’s disease (CD)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

1375

EUCTR2011-000854-44-BE
(EUCTR)

04/08/2011

20/04/2011

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease

Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

609

Phase 2

Latvia;Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1376

EUCTR2010-022758-18-HU
(EUCTR)

02/08/2011

10/08/2011

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of

1377

EUCTR2010-023589-39-GB
(EUCTR)

02/08/2011

19/05/2011

Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Hungary;Austria;Germany;United Kingdom

1378

EUCTR2010-022760-12-IS
(EUCTR)

02/08/2011

08/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1275

Phase 3

1379

NCT01352221
(ClinicalTrials.gov)

August 2011

10/5/2011

Safety 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 Disease

Drug: ST10;Drug: Placebo oral capsule

Shield Therapeutics

NULL

Completed

18 Years

N/A

All

128

Phase 3

Austria;United Kingdom

1380

EUCTR2010-022758-18-AT
(EUCTR)

28/07/2011

01/06/2011

Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

703

Phase 3

Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1381

EUCTR2010-022760-12-AT
(EUCTR)

28/07/2011

01/06/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease

Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1310

Phase 3

United States;Serbia;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan

1382

EUCTR2011-002821-24-IT
(EUCTR)

21/07/2011

27/02/2012

Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.

Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011

Treatment of active, moderate Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Rifaximin -EIR
Product Code: NA
INN or Proposed INN: RIFAXIMIN
Other descriptive name: NA

ALFA WASSERMANN

NULL

Not Recruiting

Female: yes
Male: yes

Italy

1383

EUCTR2010-022215-19-GB
(EUCTR)

21/07/2011

23/06/2011

Combined growth hormone and IGF1 therapy in paediatric Crohn'd disease

A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s

Impaired growth in Paediatric Crohn's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution
Other descriptive name: Recombinant human Insulin-like Growth Factor
Trade Name: NutropinAq®
Product Name: NutropinAq 10mg/2ml solution for injection
INN or Proposed INN: Somatropin (rhGH)
Other descriptive name: recombinant growth hormone

Greater Glasgow & Clyde NHS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

1384

EUCTR2011-000854-44-NO
(EUCTR)

19/07/2011

01/06/2011

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

609

Hungary;Czech Republic;Norway;Latvia;Poland;Sweden

1385

EUCTR2010-023034-23-GR
(EUCTR)

19/07/2011

20/06/2011

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 INSUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE

Crohn's Disease (active moderate to severe)
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1386

EUCTR2010-024638-48-ES
(EUCTR)

15/07/2011

18/11/2011

A7281007; Multi-center open-label extension study for PF-00547659

MULTICENTER OPEN-LABEL EXTENSION STUDY FOR PF-00547659(OPERA II) - OPERA II

Product Name: No aplicable
Product Code: PF-00547659
INN or Proposed INN: No aplicable
Other descriptive name: No aplicable

PFIZER, S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

180

Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

1387

EUCTR2011-002640-27-IT
(EUCTR)

14/07/2011

09/02/2012

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)

ACTIVE CROHN'S DISEASE
MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0301
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Italy

1388

EUCTR2010-018431-18-HU
(EUCTR)

14/07/2011

13/05/2011

A 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 Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

1389

EUCTR2009-016488-12-NL
(EUCTR)

12/07/2011

26/10/2010

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy

1390

EUCTR2010-022758-18-IS
(EUCTR)

08/07/2011

08/06/2011

Moderately to severely active Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Hungary;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Germany;Iceland;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1391

NCT01298492
(ClinicalTrials.gov)

July 1, 2011

26/1/2011

A Study To Monitor Long-Term Treatment With PF-00547659

A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

Crohn's Disease

Drug: PF-00547659

Shire

NULL

Completed

18 Years

75 Years

All

268

Phase 2

United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden

1392

JPRN-UMIN000005946

2011/07/01

07/07/2011

Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD

Crohn's disease

Endoscopic balloon dilation using balloon assisted enteroscopy are performed for eligible small bowel stricture of patients with CD.

Fukuoka University Chikushi Hospital

NULL

Complete: follow-up continuing

15years-old

75years-old

Male and Female

100

Not selected

Japan

1393

JPRN-UMIN000005970

2011/07/01

13/07/2011

Investigation on the remission maintaining effect of Polaprezinc in patients with Crohn's disease in remission phase.

Patients with Crohn's disease in remission phase

Polaprezinc 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 School

NULL

Recruiting

20years-old

Not applicable

Male and Female

100

Not selected

Japan

1394

NCT01369342
(ClinicalTrials.gov)

July 2011

7/6/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)

Crohn's Disease;Inflammatory Bowel Disease;IBD;Colitis

Drug: Group 1: Placebo;Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg

Janssen Research & Development, LLC

NULL

Completed

18 Years

99 Years

All

640

Phase 3

United States;Australia;Belgium;Brazil;Bulgaria;Canada;Croatia;France;Germany;Hungary;Iceland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Ireland

1395

NCT01369329
(ClinicalTrials.gov)

July 2011

7/6/2011

A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

Crohn's Disease;IBD;Colitis;Inflammatory Bowel Disease

Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg;Drug: Group 1: Placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

N/A

All

769

Phase 3

United States;Australia;Austria;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Serbia;South Africa;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1396

EUCTR2010-020836-21-PL
(EUCTR)

29/06/2011

28/06/2011

A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease

Product Name: NNC0142-0000-0002
Product Code: NNC142-0002
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Hungary;European Union;Canada;Belgium;Poland;Israel;Russian Federation

1397

EUCTR2011-002061-38-BE
(EUCTR)

29/06/2011

08/06/2011

Treating patients with infliximab based on their trough levels

A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT

2) Crohn's disease and ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
Product Code: Remicade
INN or Proposed INN: INFLIXIMAB

Katholieke Universiteit Leuven

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

1398

EUCTR2010-023589-39-AT
(EUCTR)

22/06/2011

17/05/2011

Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

1399

EUCTR2010-023034-23-IE
(EUCTR)

03/06/2011

07/04/2011

A 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 Responsers

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

1400

EUCTR2010-023437-30-ES
(EUCTR)

03/06/2011

13/06/2011

Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA

Enfermedad de Crohn Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: PF-00547659
Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: No aplicable

PFIZER SLU

NULL

Not Recruiting

Female: yes
Male: yes

240

Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1401

EUCTR2010-023437-30-AT
(EUCTR)

01/06/2011

25/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

1402

JPRN-UMIN000005251

2011/06/01

01/06/2011

A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab

Crohn's disease

Administration 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 University

NULL

Complete: follow-up complete

16years-old

Not applicable

Male and Female

Not selected

Japan

1403

EUCTR2010-024638-48-SE
(EUCTR)

01/06/2011

25/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland

1404

EUCTR2010-024638-48-AT
(EUCTR)

01/06/2011

25/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

1405

EUCTR2010-023437-30-SE
(EUCTR)

01/06/2011

25/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1406

NCT01355614
(ClinicalTrials.gov)

June 2011

16/5/2011

A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease

Crohn's Disease

Drug: QAX576;Drug: Infliximab

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

Phase 2

Germany;Switzerland

1407

NCT01345318
(ClinicalTrials.gov)

June 2011

28/4/2011

B0151005 Open-Label Extension Study

A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

Crohn's Disease

Biological: PF-04236921

Pfizer

NULL

Completed

N/A

All

191

Phase 2

United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;New Zealand;Switzerland;United Kingdom

1408

EUCTR2010-022384-35-BE
(EUCTR)

30/05/2011

07/12/2010

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

1409

EUCTR2010-022383-12-BE
(EUCTR)

30/05/2011

07/12/2010

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

1410

EUCTR2010-023437-30-BE
(EUCTR)

27/05/2011

25/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1411

EUCTR2010-020881-53-ES
(EUCTR)

25/05/2011

01/12/2010

Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease.

Crohn's disease / Enfermedad de Crohn
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

195

Netherlands;Belgium;Spain

1412

EUCTR2010-022384-35-CZ
(EUCTR)

13/05/2011

31/03/2011

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - SHIELD 3

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

1413

EUCTR2010-022383-12-CZ
(EUCTR)

12/05/2011

30/03/2011

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease - SHIELD 2

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

1414

NCT01316939
(ClinicalTrials.gov)

May 9, 2011

3/3/2011

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

Crohn's Disease

Drug: GSK1605786A;Drug: Placebo

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

229

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland

1415

EUCTR2010-022384-35-DK
(EUCTR)

06/05/2011

01/04/2011

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1416

EUCTR2011-000854-44-SE
(EUCTR)

02/05/2011

01/03/2011

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study.

A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

609

Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia

1417

ChiCTR-TRC-11001321

2011-05-01

Effect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's Disease

Crohn's disease;ICD:K50.9

control 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 University

NULL

Completed

Both

control group:30;?-3 Fat group:30;

China

1418

NCT01346826
(ClinicalTrials.gov)

May 2011

2/5/2011

Safety 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 Trial

Crohn's Disease;Ulcerative Colitis

Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion

Asan Medical Center

NULL

Completed

16 Years

80 Years

Both

145

Phase 4

Korea, Republic of

1419

EUCTR2010-019996-32-BG
(EUCTR)

27/04/2011

24/02/2011

A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005

Moderate to severe Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 2

France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany

1420

EUCTR2010-022383-12-DK
(EUCTR)

08/04/2011

02/03/2011

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1421

NCT01276509
(ClinicalTrials.gov)

April 6, 2011

12/1/2011

Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

A 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 Disease

Drug: PF-00547659 SC injection

Shire

NULL

Completed

18 Years

75 Years

All

265

Phase 2

United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden

1422

EUCTR2010-020881-53-NL
(EUCTR)

04/04/2011

17/12/2010

A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease

Crohns Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

195

Netherlands;Belgium;Spain

1423

EUCTR2009-016488-12-DE
(EUCTR)

04/04/2011

12/11/2010

Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

United States;Slovakia;Turkey;Austria;Israel;Italy;France;Hungary;Czech Republic;Canada;Malaysia;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand;Korea, Republic of

1424

NCT01318993
(ClinicalTrials.gov)

April 1, 2011

3/3/2011

Open-Label Extension Study of GSK1605786A

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

Crohn's Disease

Drug: GSK1605786A

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

399

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;New Zealand;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland

1425

NCT02504255
(ClinicalTrials.gov)

April 2011

20/7/2015

Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease

Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort

Crohn Disease

Biological: Biological samplings;Other: Questionnaires

Hospices Civils de Lyon

NULL

Completed

18 Years

N/A

Both

144

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1426

NCT01341808
(ClinicalTrials.gov)

April 2011

25/4/2011

Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients

Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis A

Biological: Epaxal Berna (virosomal hepatitis A vaccine)

Asan Medical Center

NULL

Completed

18 Years

40 Years

Both

493

Phase 4

Korea, Republic of

1427

NCT01345799
(ClinicalTrials.gov)

April 2011

28/4/2011

A Study of TRK-170 for the Treatment of Crohn's Disease

A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Crohn's Disease

Drug: TRK-170;Drug: Placebo

Toray Industries, Inc

NULL

Completed

18 Years

50 Years

Both

123

Phase 2

Belgium;Bulgaria;Czech Republic;France;Hungary;Latvia;Netherlands;Norway;Poland;Romania;Serbia;Sweden;Ukraine

1428

EUCTR2010-019996-32-DE
(EUCTR)

31/03/2011

22/11/2010

A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease

Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 2

France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany

1429

EUCTR2009-016488-12-IT
(EUCTR)

23/03/2011

18/05/2011

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease - ND

moderate to Severe Crhon`s Disease
MedDRA version: 13.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Monoclonal antibodies

MILLENNIUM PHARMACEUTICALS, INC.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy

1430

EUCTR2010-020137-10-BE
(EUCTR)

23/03/2011

04/10/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1431

EUCTR2010-022384-35-GB
(EUCTR)

22/03/2011

30/12/2010

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden

1432

EUCTR2010-019996-32-HU
(EUCTR)

18/03/2011

31/01/2011

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease

Crohn’s Disease
MedDRA version: 12.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 2

Hungary;Belgium;Bulgaria;Netherlands;Germany

1433

EUCTR2010-023347-14-BE
(EUCTR)

02/03/2011

04/01/2011

Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LARAn open pilot study

Crohn Disease refractory diarrhoea
MedDRA version: 12.1;Level: LLT;Classification code 10066533;Term: Diarrhea recurrent

Trade Name: Sandostatine
Product Name: sandostatine
Trade Name: Sandostatine
Product Name: sandostatine

Gastroenterology CHC Liege

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

1434

EUCTR2010-022384-35-SE
(EUCTR)

01/03/2011

15/12/2010

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

1435

JPRN-UMIN000005146

2011/03/01

25/02/2011

Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)

Crohn's disease

Administration 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 University

NULL

Complete: follow-up complete

15years-old

Not applicable

Male and Female

200

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1436

EUCTR2010-022383-12-SE
(EUCTR)

01/03/2011

15/12/2010

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

1437

EUCTR2009-010727-91-DE
(EUCTR)

01/03/2011

05/06/2012

Colesevelam, which is a medication which binds bile acid, to test in patients with Crohns disease

Colesevelam for the treatment of bile acid malabsorption in patients with Crohn’s disease (Colesevelam für die Therapie der Gallensäuren-Malabsorption bei M. Crohn-Patienten)

Morbus Crohn
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Cholestagel
Product Name: Cholestagel
Product Code: EU/1/03/268/002
INN or Proposed INN: Colesevelam

LMU München, Campus Großhadern

NULL

Not Recruiting

Female: yes
Male: yes

Germany

1438

NCT01258205
(ClinicalTrials.gov)

February 28, 2011

9/12/2010

Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects

A 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 Disease

Crohn's Disease

Drug: AMG 139

Allergan

NULL

Completed

18 Years

55 Years

All

Phase 1

United States;Australia

1439

EUCTR2010-022383-12-GB
(EUCTR)

24/02/2011

23/12/2010

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;Norway;Sweden

1440

EUCTR2009-016488-12-SK
(EUCTR)

23/02/2011

27/10/2010

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Czech Republic;Hungary;Slovakia;Belgium;Austria;Germany;Netherlands;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1441

EUCTR2010-022383-12-NL
(EUCTR)

16/02/2011

29/10/2010

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A
INN or Proposed INN: GSK1605786A
Other descriptive name: na

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

United 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

1442

EUCTR2010-022382-10-NL
(EUCTR)

16/02/2011

29/10/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: GSK1605786A
Product Code: GSK1605786A
Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;Czech Republic;Spain;Belgium;Austria;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden

1443

EUCTR2010-024528-12-DK
(EUCTR)

14/02/2011

24/01/2011

Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT

Morbus Crohn disease with signs of activity in the small bowel.
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: SonoVue
Other descriptive name: SULFUR HEXAFLUORIDE

Henning Glerup

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

1444

EUCTR2010-019996-32-CZ
(EUCTR)

11/02/2011

26/11/2010

A phase II, randomized, double-blind, placebo-controlled study toevaluate the clinical efficacy, safety and immunogenicity ofNeovacs'TNFa-Kinoid in adult subjects with Crohn's Disease

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease

Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 2

France;Hungary;Czech Republic;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany

1445

NCT01235689
(ClinicalTrials.gov)

February 11, 2011

4/11/2010

Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Biological: Adalimumab;Drug: Prednisone;Drug: Azathioprine

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

75 Years

All

252

Phase 3

Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1446

EUCTR2009-016488-12-BE
(EUCTR)

08/02/2011

25/11/2010

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Czech Republic;Hungary;Slovakia;Belgium;Austria;Germany;Netherlands;Italy

1447

EUCTR2010-022382-10-BE
(EUCTR)

07/02/2011

07/12/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden

1448

EUCTR2009-016488-12-CZ
(EUCTR)

04/02/2011

25/11/2010

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Netherlands;Italy

1449

EUCTR2010-022384-35-DE
(EUCTR)

02/02/2011

10/11/2010

A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study

Subjects with Crohn’s Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

1450

NCT01290042
(ClinicalTrials.gov)

February 2011

27/1/2011

Study 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 Disease

Drug: AMG 181;Other: Placebo for AMG 181

Amgen

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States;Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1451

NCT01291810
(ClinicalTrials.gov)

February 2011

17/12/2010

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's Disease

Crohn's Disease

Biological: TNF Kinoid;Biological: WFI

Neovacs

NULL

Completed

18 Years

65 Years

Both

Phase 2

Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania

1452

NCT01203631
(ClinicalTrials.gov)

February 2011

15/9/2010

Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

A 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 Disease

Inflammation;Crohn's Disease

Drug: NNC 0142-0000-0002;Drug: Placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

75 Years

Both

Phase 2

United States;Belgium;Canada;France;Hungary;Israel;Poland;Russian Federation

1453

NCT01287897
(ClinicalTrials.gov)

February 2011

31/1/2011

A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

A 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 Disease

Drug: PF-04236921 SC injection

Pfizer

NULL

Completed

18 Years

75 Years

All

250

Phase 2

United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;New Zealand;Romania;Switzerland;United Kingdom;Sweden

1454

EUCTR2010-022382-10-SE
(EUCTR)

20/01/2011

09/11/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden

1455

EUCTR2010-022382-10-DK
(EUCTR)

19/01/2011

10/12/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1456

EUCTR2010-020881-53-BE
(EUCTR)

18/01/2011

24/11/2010

Safety Study in Subjects With Crohn's Disease

A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease

Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands

1457

EUCTR2010-019973-13-DE
(EUCTR)

14/01/2011

30/09/2010

A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease

Treatment of perianal fistulas in patients suffering from Crohn's Disease.
MedDRA version: 14.0;Level: PT;Classification code 10016717;Term: Fistula;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Product Code: QAX576
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Switzerland

1458

EUCTR2010-019996-32-BE
(EUCTR)

12/01/2011

04/10/2010

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease

Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 2

France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany

1459

EUCTR2010-022382-10-DE
(EUCTR)

11/01/2011

22/10/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Japan;Sweden

1460

EUCTR2010-020836-21-BE
(EUCTR)

07/01/2011

15/09/2010

Product Name: NNC0142-0000-0002
Product Code: NNC142-0002
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Hungary;European Union;Canada;Poland;Belgium;Israel;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1461

EUCTR2010-022017-26-GB
(EUCTR)

07/01/2011

08/12/2010

A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease

Crohn's disease
MedDRA version: 12.;Level: LLT;Classification code 10013099;Term: Disease Crohns

Central Manchester University Hospitals Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

1462

EUCTR2010-019544-39-NL
(EUCTR)

06/01/2011

30/08/2010

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease

Crohn’s disease
MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated

Product Name: AMG 827
Product Code: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

216

Netherlands;Belgium;France;Spain

1463

EUCTR2010-022383-12-NO
(EUCTR)

06/01/2011

02/12/2010

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Subjects with Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden

1464

EUCTR2010-022382-10-GB
(EUCTR)

06/01/2011

12/10/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden

1465

EUCTR2009-016488-12-AT
(EUCTR)

05/01/2011

18/11/2010

Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

United States;Slovakia;Turkey;Austria;Israel;Italy;France;Hungary;Czech Republic;Canada;Malaysia;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1466

NCT01245088
(ClinicalTrials.gov)

January 2011

19/11/2010

Chondroitin Sulfate for Crohn's Disease

A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease

Crohn's Disease

Drug: chondroitin sulfate

University Hospital Case Medical Center

NULL

Withdrawn

18 Years

80 Years

Both

Phase 1;Phase 2

United States

1467

EUCTR2009-016488-12-HU
(EUCTR)

28/12/2010

10/11/2010

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy

1468

EUCTR2010-022382-10-CZ
(EUCTR)

22/12/2010

04/11/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden

1469

NCT01277666
(ClinicalTrials.gov)

December 20, 2010

13/1/2011

A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

Crohn's Disease

Drug: GSK1605786A;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

608

Phase 3

United 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

1470

EUCTR2010-020137-10-NL
(EUCTR)

17/12/2010

23/12/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1471

EUCTR2010-018431-18-IT
(EUCTR)

03/12/2010

10/01/2011

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT

Crohn`s disease (DS)
MedDRA version: 9.1;Level: LLT;Classification code 10011401

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

CENTOCOR

NULL

Not Recruiting

Female: yes
Male: yes

290

France;Czech Republic;Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Italy

1472

NCT01199302
(ClinicalTrials.gov)

December 2010

9/9/2010

Safety Study in Subjects With Crohn's Disease

A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease

Crohn's Disease

Drug: AMG 827

Amgen

NULL

Terminated

N/A

Both

Phase 2

United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain

1473

NCT01233960
(ClinicalTrials.gov)

November 29, 2010

2/11/2010

Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

A 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 Disease

Crohn's Disease

Drug: adult human mesenchymal stem cells

Mesoblast, Inc.

NULL

Completed

18 Years

70 Years

All

Phase 3

United States;Australia;New Zealand

1474

EUCTR2010-019544-39-ES
(EUCTR)

25/11/2010

03/09/2010

Estudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease

Crohn's disease / Enfermedad de Crohn
MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated

Product Name: AMG 827
Product Code: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

216

Netherlands;Belgium;France;Spain

1475

EUCTR2010-018431-18-BE
(EUCTR)

19/11/2010

28/07/2010

A 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 Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1476

EUCTR2010-020137-10-CZ
(EUCTR)

08/11/2010

04/08/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

1477

EUCTR2010-020137-10-IT
(EUCTR)

07/11/2010

08/11/2010

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM

Crohn`s disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401

Abbott GmBH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden

1478

NCT01190839
(ClinicalTrials.gov)

November 2010

12/8/2010

A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence

Crohn's Disease

Biological: Infliximab;Drug: Placebo

Janssen Biotech, Inc.

NULL

Terminated

18 Years

99 Years

All

297

Phase 3

United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;New Zealand;Poland;United Kingdom;Denmark;Spain

1479

NCT01224171
(ClinicalTrials.gov)

November 2010

18/10/2010

Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: vedolizumab;Other: Placebo

Millennium Pharmaceuticals, Inc.

NULL

Completed

18 Years

80 Years

All

416

Phase 3

United States;Canada;Puerto Rico

1480

NCT01279577
(ClinicalTrials.gov)

November 2010

18/1/2011

Trichuris Suis Ova (TSO) Suspension Versus Placebo in 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

Crohn´s Disease

Drug: Low dose TSO;Drug: Medium dose TSO;Drug: High dose TSO;Drug: Placebo

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

75 Years

Both

254

Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1481

NCT01094613
(ClinicalTrials.gov)

November 2010

25/3/2010

Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease

MultiCTR 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 Disease

Crohn's Disease

Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine

Teva GTC

NULL

Terminated

18 Years

75 Years

Both

Phase 1;Phase 2

Israel

1482

EUCTR2010-018431-18-NL
(EUCTR)

28/10/2010

20/09/2010

A 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 Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

1483

JPRN-UMIN000005761

2010/10/27

13/06/2011

The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab

Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.

Adalimumab (HUMIRA 40mg for SC Injection)

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

Kenji Watanabe

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not selected

Japan

1484

JPRN-UMIN000005762

2010/10/27

13/06/2011

The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease

Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.

1)Adalimumab (HUMIRA 40mg for SC Injection)

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

2)Elental(1 kcal/ml; 80g/300ml)

Kenji Watanabe

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not selected

Japan

1485

EUCTR2006-000720-13-DE
(EUCTR)

27/10/2010

29/01/2010

Study to evaluate the effectiveness and safety of 3 doses of embryonated eggs of the porcine whipworm compared to placebo (dummy drug) in the treatment of active Crohn's disease.

Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease

Induction of remission in active Crohn´s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Czech Republic;Denmark;Austria;Germany;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1486

EUCTR2010-020836-21-HU
(EUCTR)

26/10/2010

28/09/2010

Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: NNC0142-0000-0002
Product Code: NNC142-0002

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

150

Hungary;Poland;Belgium

1487

EUCTR2010-020137-10-ES
(EUCTR)

20/10/2010

20/08/2010

Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

Enfermedad de Crohn.Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

1488

EUCTR2006-002078-23-IE
(EUCTR)

20/10/2010

25/09/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1489

EUCTR2006-000720-13-CZ
(EUCTR)

18/10/2010

30/06/2010

Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.

Induction of remission in active Crohn´s disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Czech Republic;Denmark;Austria;Germany;Switzerland

1490

EUCTR2010-020137-10-FR
(EUCTR)

14/10/2010

23/08/2010

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1491

EUCTR2010-020137-10-DE
(EUCTR)

05/10/2010

20/07/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

1492

EUCTR2010-019544-39-FR
(EUCTR)

04/10/2010

06/09/2010

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease

Crohn’s disease
MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated

Product Name: AMG 827
Product Code: AMG 827

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

216

Netherlands;Belgium;France;Spain

1493

EUCTR2010-019544-39-BE
(EUCTR)

04/10/2010

17/08/2010

AMG 827 in Subjects With Moderate to Severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease

Crohn’s disease
MedDRA version: 14.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

216

Phase 2

France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands

1494

NCT01231217
(ClinicalTrials.gov)

October 2010

27/10/2010

Green Tea in Crohn's Disease

Crohn's Disease

Other: Green tea (Camellia sinensis);Other: Coffee

University Hospital Heidelberg

NULL

Recruiting

18 Years

N/A

Both

N/A

Germany

1495

NCT01203254
(ClinicalTrials.gov)

October 2010

15/9/2010

Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

Crohns Disease;Bile Acid Malabsorption

Drug: Colesevelam;Drug: Placebo

Florian Beigel

NULL

Terminated

18 Years

65 Years

Both

Phase 4

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1496

NCT01111292
(ClinicalTrials.gov)

October 2010

24/4/2010

Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia

Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia

Colon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal Carcinoma

Drug: Inositol;Other: Placebo

National Cancer Institute (NCI)

NULL

Terminated

18 Years

N/A

All

Phase 1;Phase 2

United States

1497

EUCTR2010-020137-10-GB
(EUCTR)

20/09/2010

19/07/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

1498

EUCTR2010-020137-10-AT
(EUCTR)

16/09/2010

11/08/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

1499

EUCTR2010-020137-10-SE
(EUCTR)

15/09/2010

27/07/2010

Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden

1500

EUCTR2010-018431-18-FR
(EUCTR)

15/09/2010

09/07/2010

Crohn’s disease (CD)
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Italy;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1501

NCT01215890
(ClinicalTrials.gov)

September 2010

5/10/2010

Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease

A 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 Patients

Crohn's Disease;Low Bone Mineral Density

Drug: risedronate;Drug: placebo

University of Alberta

NULL

Completed

18 Years

N/A

Both

Phase 4

Canada

1502

NCT01233570
(ClinicalTrials.gov)

September 2010

2/11/2010

Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease

Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease

Crohn Disease

Drug: Tacrolimus

University of Aberdeen

NULL

Completed

12 Years

N/A

Both

Phase 2

United Kingdom

1503

EUCTR2010-018431-18-DE
(EUCTR)

23/08/2010

24/06/2010

A 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 Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

1504

EUCTR2010-018431-18-GB
(EUCTR)

16/08/2010

06/07/2010

A 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 Recurrence

Crohn’s disease (CD)
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Phase 3

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

1505

EUCTR2010-018431-18-AT
(EUCTR)

06/08/2010

05/07/2010

A 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 Recurrence

Crohn’s disease (CD)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1506

NCT01261286
(ClinicalTrials.gov)

August 2010

14/12/2010

Drug-Disease Interaction in Crohn's Disease

Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients

Crohn's Disease

Drug: verapamil

University of Alberta

NULL

Completed

18 Years

65 Years

Both

Phase 1

Canada

1507

NCT01190410
(ClinicalTrials.gov)

August 2010

25/8/2010

Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

An 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 C87035

Crohn's Disease

Drug: certolizumab pegol

UCB Pharma

NULL

Completed

6 Years

17 Years

All

Phase 2

United States;Australia;Canada

1508

NCT01611805
(ClinicalTrials.gov)

July 22, 2010

12/4/2012

Japanese Phase I of GSK1605786

A 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 Subject

Crohn's Disease

Drug: GSK1605786;Drug: GSK1605786 Placebo

GlaxoSmithKline

NULL

Completed

20 Years

55 Years

Male

Phase 1

Australia

1509

NCT01510431
(ClinicalTrials.gov)

July 2010

9/1/2012

Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

An 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 Disease

Crohn's Disease

Drug: PROCHYMAL (remestemcel-L)

Mesoblast, Inc.

NULL

No longer available

18 Years

70 Years

All

United States

1510

NCT01150890
(ClinicalTrials.gov)

July 2010

24/6/2010

AMG 827 in Subjects With Moderate to Severe Crohn's Disease

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: AMG 827 350 MG;Drug: AMG 827 210 MG;Drug: AMG 827 700 MG;Drug: Placebo

Amgen

NULL

Terminated

18 Years

65 Years

Both

130

Phase 2

United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1511

EUCTR2006-000720-13-DK
(EUCTR)

22/06/2010

17/03/2010

Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Czech Republic;Austria;Denmark;Germany;Switzerland

1512

EUCTR2009-015680-14-NL
(EUCTR)

18/05/2010

27/07/2010

Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula

single or multiple draining perianal fistulas as a result of Crohn's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Bone Marrow Derived Mesenchymal Stem cells (MSCs)
Product Code: NA

Leiden University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands

1513

EUCTR2009-011621-14-DE
(EUCTR)

12/05/2010

26/01/2010

A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/a

Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: AIN457
Product Code: AIN457

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Austria

1514

NCT01114607
(ClinicalTrials.gov)

May 5, 2010

29/4/2010

A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects

A 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 Subjects

Crohn's Disease

Drug: 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 E

GlaxoSmithKline

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

1515

NCT00737932
(ClinicalTrials.gov)

May 2010

18/8/2008

Laquinimod Phase IIa Study in Active Crohn's Disease

A 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 Disease

Drug: Laquinimod;Other: placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

75 Years

Both

180

Phase 2

Belgium;France;Israel;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1516

EUCTR2008-005903-25-BG
(EUCTR)

23/04/2010

14/04/2010

Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)

inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS

Product Name: SC12267
Product Code: SC12267
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon
Trade Name: Prednisolon Jenapharm
INN or Proposed INN: Prednisolon

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Bulgaria

1517

EUCTR2006-000720-13-AT
(EUCTR)

07/04/2010

03/03/2010

Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Czech Republic;Denmark;Austria;Germany;Switzerland

1518

EUCTR2008-002784-14-GB
(EUCTR)

26/03/2010

28/06/2010

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1519

EUCTR2008-002784-14-SE
(EUCTR)

12/02/2010

23/01/2009

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1520

NCT00988832
(ClinicalTrials.gov)

February 2010

1/10/2009

An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab

Crohn's Disease

Biological: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

380

N/A

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1521

NCT01037322
(ClinicalTrials.gov)

January 2010

20/12/2009

Cannabidiol for Inflammatory Bowel Disease

Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis

Drug: cannabidiol;Drug: placebo in drops

Meir Medical Center

NULL

Completed

20 Years

80 Years

Both

Phase 1;Phase 2

Israel

1522

NCT01548014
(ClinicalTrials.gov)

January 2010

17/2/2012

The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease

Reduction 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 Study

Crohn's Disease

Dietary Supplement: VSL#3

Samsung Medical Center

NULL

Recruiting

13 Years

17 Years

Both

Phase 3

Korea, Republic of

1523

NCT01040910
(ClinicalTrials.gov)

January 2010

29/12/2009

Cannabis for Inflammatory Bowel Disease

A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis

Drug: smoking of cannabis;Drug: smoking cigarettes with placebo

Meir Medical Center

NULL

Recruiting

20 Years

70 Years

Both

Phase 1;Phase 2

Israel

1524

NCT01288053
(ClinicalTrials.gov)

January 2010

27/1/2011

Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease

Crohn's Disease

Biological: Allogeneic Stem Cell Therapy

Northwestern University

NULL

Terminated

18 Years

45 Years

All

Phase 1;Phase 2

United States

1525

EUCTR2007-006494-90-GB
(EUCTR)

24/12/2009

18/06/2009

A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Abbott GmbH & Co. K.G.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

Czech Republic;Belgium;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1526

EUCTR2008-005237-30-NL
(EUCTR)

01/12/2009

18/08/2009

A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis

A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP

Pediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima and Inflectra

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

6000

United States;Canada;Netherlands;Sweden

1527

EUCTR2008-006957-42-BG
(EUCTR)

17/11/2009

21/08/2009

Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease

Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania

1528

EUCTR2009-011621-14-AT
(EUCTR)

12/11/2009

19/10/2009

A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1

Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: Not available
Other descriptive name: None

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Austria

1529

JPRN-UMIN000002796

2009/11/01

25/11/2009

Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.

Crohn's disease

We 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 University

NULL

Recruiting

16years-old

65years-old

Male and Female

Phase 2

Japan

1530

NCT01015391
(ClinicalTrials.gov)

November 2009

17/11/2009

Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease

A 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 Resection

Crohn's Disease

Drug: T2;Drug: Azathioprine

Jinling Hospital, China

NULL

Recruiting

18 Years

N/A

Both

100

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1531

NCT01086553
(ClinicalTrials.gov)

November 2009

12/3/2010

9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

Double-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

Crohn´s Disease

Drug: budesonide

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

75 Years

Both

471

Phase 3

Germany

1532

EUCTR2008-006957-42-DE
(EUCTR)

30/10/2009

30/07/2009

Induction of remission in active Crohn´s disease
MedDRA version: 14.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany

1533

EUCTR2009-011220-62-NL
(EUCTR)

26/10/2009

13/07/2009

A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study

1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: mesalazine
INN or Proposed INN: mesalazine
Other descriptive name: AMINOSALICYLIC ACID

University Medical Center Utrecht

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands

1534

EUCTR2008-006957-42-LT
(EUCTR)

19/10/2009

12/08/2009

Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania

1535

EUCTR2008-006957-42-SK
(EUCTR)

14/10/2009

19/10/2009

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1536

NCT00989573
(ClinicalTrials.gov)

October 2009

2/10/2009

A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Crohn's Disease

Drug: Placebo;Drug: OPC-6535

Otsuka Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

64 Years

Both

191

Phase 2;Phase 3

Japan;Korea, Republic of

1537

NCT01009281
(ClinicalTrials.gov)

October 2009

5/11/2009

An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease

A 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

Crohn's Disease;Inflammatory Bowel Disease

Drug: AIN457

Novartis Pharmaceuticals

NULL

Terminated

18 Years

75 Years

All

Phase 2

United States;Austria;Canada;Germany;Poland

1538

NCT01661257
(ClinicalTrials.gov)

October 2009

7/8/2012

Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy

Expression 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 Therapy

Crohn's Disease

Drug: Infliximab

Samsung Medical Center

NULL

Completed

13 Years

17 Years

Both

Phase 3

Korea, Republic of

1539

EUCTR2008-006957-42-LV
(EUCTR)

25/09/2009

08/09/2009

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia

1540

EUCTR2008-006957-42-CZ
(EUCTR)

24/09/2009

07/09/2009

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1541

EUCTR2008-006957-42-HU
(EUCTR)

16/09/2009

04/08/2009

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania

1542

EUCTR2008-008359-40-DE
(EUCTR)

08/09/2009

23/06/2009

A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202

Moderate to severe Crohn's disease (CDAI >/= 220 and MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Poland;Austria

1543

EUCTR2008-008359-40-PL
(EUCTR)

02/09/2009

07/04/2009

A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202

Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: AIN457
Product Code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class) rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Austria;Poland

1544

EUCTR2008-002784-14-DE
(EUCTR)

02/09/2009

02/06/2009

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia

1545

NCT00999115
(ClinicalTrials.gov)

September 2009

20/10/2009

Allogenic 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 Disease

Rectovaginal Fistula;Crohn Disease

Drug: Expanded allogenic adipose-derived adult stem cells

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

NULL

Completed

18 Years

N/A

Female

Phase 1;Phase 2

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1546

NCT02322008
(ClinicalTrials.gov)

September 2009

17/12/2014

Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease

Biological: infliximab and adalimumab

Regionshospitalet Viborg, Skive

NULL

Completed

18 Years

N/A

Both

1035

N/A

NULL

1547

EUCTR2008-002783-33-DE
(EUCTR)

24/08/2009

23/04/2009

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1116

Phase 3

Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Norway;Germany;New Zealand;Sweden

1548

EUCTR2008-002784-14-AT
(EUCTR)

13/08/2009

28/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1549

EUCTR2009-013348-35-NL
(EUCTR)

04/08/2009

03/07/2009

(Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease

Patients with quiescent Crohn’s colitis, defined as a Crohn’s Disease Activity Index <150 ; non-IBD patients will serve as disease controls.
MedDRA version: 9.1;Level: LLT;Classification code 10011400;Term: Crohn's colitis
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10011402;Term: Crohn's disease (colon)

Trade Name: Chenofalk
Product Name: Chenofalk
Product Code: RVG 07151
INN or Proposed INN: CHENODEOXYCHOLIC ACID
Other descriptive name: Chenodiol

University Medical Center Utrecht

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands

1550

NCT00367705
(ClinicalTrials.gov)

August 2009

22/8/2006

VSL#3 Treatment in Children With Crohn's Disease

Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease

Crohn's Disease

Dietary Supplement: VSL#3®;Dietary Supplement: Placebo

Hadassah Medical Organization

NULL

Not yet recruiting

6 Years

18 Years

Both

300

Phase 4

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1551

NCT01012570
(ClinicalTrials.gov)

August 2009

11/11/2009

The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients

Crohn's Disease

Drug: Application of Adalimumab

Gerhard Rogler

NULL

Terminated

18 Years

65 Years

Both

Switzerland

1552

EUCTR2008-007329-38-ES
(EUCTR)

24/07/2009

24/04/2009

Estudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease

Pacientes con enfermedad de Crohn dependiente de esteroides
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
INN or Proposed INN: fosfato sodico de dexametasona

ERYDEL S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

184

Spain;Italy

1553

EUCTR2009-011763-37-IT
(EUCTR)

22/07/2009

16/04/2009

THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - ND

Crohn`s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10038283;Term: Regional enteritis of small intestine with large intestine

INN or Proposed INN: Adalimumab

ISTITUTO CLINICO HUMANITAS

NULL

Not Recruiting

Female: yes
Male: yes

Italy

1554

EUCTR2008-002783-33-IT
(EUCTR)

22/07/2009

17/03/2009

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 - ND

Patients with Moderate to Severe Crohn?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Vedolizumab
Product Code: MLN0002

MILLENNIUM PHARMACEUTICALS, INC.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1555

EUCTR2008-002783-33-GB
(EUCTR)

20/07/2009

27/11/2008

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1556

EUCTR2008-002783-33-CZ
(EUCTR)

13/07/2009

31/10/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1557

EUCTR2008-005688-32-CZ
(EUCTR)

02/07/2009

05/01/2009

Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.

Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions).
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Univeristy Hospital Na Bulovce

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Czech Republic

1558

JPRN-UMIN000002074

2009/07/01

01/07/2009

Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL

Crohn's disease

Rosuvastatin (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 Medicine

NULL

Complete: follow-up complete

20years-old

65years-old

Male and Female

Phase 2

Japan

1559

NCT00950105
(ClinicalTrials.gov)

July 2009

29/7/2009

Single 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 Subjects

Crohn's Disease

Drug: CPSI-2364 or placebo

Ferring Pharmaceuticals

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

1560

EUCTR2008-002783-33-GR
(EUCTR)

18/06/2009

05/11/2009

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1561

EUCTR2009-010163-16-GB
(EUCTR)

05/06/2009

18/08/2009

Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease - Bile salt manipulation in Crohn’s disease

Active Crohn's disease affecting the ileum
MedDRA version: 9.1;Level: LLT;Classification code 10011406;Term: Crohn's ileitis
MedDRA version: 9.1;Classification code 10058815;Term: Crohn's disease acute episode

University College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

1562

EUCTR2006-004784-58-GB
(EUCTR)

03/06/2009

30/04/2009

An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

University of Leuven Hospitals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France;Belgium;Germany;United Kingdom

1563

NCT01372969
(ClinicalTrials.gov)

June 2009

30/8/2010

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.

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 Fistula

Drug: Cx601

Tigenix S.A.U.

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

Spain

1564

NCT00790933
(ClinicalTrials.gov)

May 22, 2009

5/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease

Ulcerative Colitis;Crohn's Disease

Drug: Vedolizumab

Takeda

NULL

Completed

18 Years

N/A

All

2243

Phase 3

United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic

1565

EUCTR2008-004919-36-AT
(EUCTR)

20/05/2009

10/11/2008

A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: ABT-874
Product Code: ABT-874
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0

Abbott

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2B

Denmark;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1566

EUCTR2008-008359-40-AT
(EUCTR)

07/05/2009

31/03/2009

A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202

Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: AIN457
Product Code: AIN457

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Poland;Austria

1567

JPRN-UMIN000002604

2009/05/01

01/11/2009

Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease

Crohn's disease

Patients 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 Japan

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

100

Phase 4

Japan

1568

NCT00889161
(ClinicalTrials.gov)

May 2009

24/4/2009

Curcumin in Pediatric Inflammatory Bowel Disease

Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study

Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease

Drug: Curcumin

Seattle Children's Hospital

NULL

Completed

8 Years

18 Years

Both

Phase 1

United States

1569

NCT00742781
(ClinicalTrials.gov)

May 2009

26/8/2008

Vitamin D Supplementation in Crohn's Patients

Vitamin D and Crohn's Disease From the Bench to the Clinic

Inflammatory Bowel Disease

Dietary Supplement: Vitamin D

Penn State University

NULL

Completed

18 Years

70 Years

All

Phase 1

United States

1570

EUCTR2008-004286-25-DE
(EUCTR)

28/04/2009

21/08/2008

Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT II

Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula

Product Name: ASCs : Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells

CELLERIX S.A.

NULL

Not Recruiting

Female: yes
Male: yes

196

Phase 3

Czech Republic;Germany;Netherlands;Belgium;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1571

EUCTR2008-002784-14-EE
(EUCTR)

28/04/2009

27/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;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

1572

EUCTR2008-002784-14-BE
(EUCTR)

21/04/2009

14/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1573

EUCTR2008-002784-14-HU
(EUCTR)

20/04/2009

27/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1574

EUCTR2008-007519-34-SE
(EUCTR)

17/04/2009

02/03/2009

Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION

This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with

Trade Name: Remicade

University of Leuven Hospitals, Division of Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Sweden

1575

EUCTR2008-006484-36-IT
(EUCTR)

16/04/2009

24/04/2009

MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE

Moderate-to-severe active Crohn`sdisease.
MedDRA version: 9.1;Level: LLT;Classification code 10011398;Term: Crohn's

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1576

EUCTR2008-002783-33-SE
(EUCTR)

15/04/2009

22/01/2009

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1577

EUCTR2008-002783-33-HU
(EUCTR)

14/04/2009

27/10/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1578

EUCTR2008-002784-14-GR
(EUCTR)

07/04/2009

05/11/2009

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1579

NCT00862121
(ClinicalTrials.gov)

April 2009

13/3/2009

A Study With Pentasa in Patients With Active Crohn's Disease

PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.

Crohn´s Disease

Drug: Pentasa;Drug: Placebo

Ferring Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

Phase 3

United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain

1580

NCT00899678
(ClinicalTrials.gov)

April 2009

29/4/2009

The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents

A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)

Crohn's Disease

Drug: Certolizumab Pegol

UCB Celltech

NULL

Terminated

6 Years

17 Years

All

Phase 2

United States;Australia;Canada;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1581

NCT01277289
(ClinicalTrials.gov)

April 2009

5/1/2011

Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

Crohn's Disease

Drug: Dexamethasone

Erydel

NULL

Terminated

18 Years

80 Years

Both

Phase 3

Italy;Romania;Spain

1582

EUCTR2008-004286-25-BE
(EUCTR)

30/03/2009

11/09/2008

Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT II

Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula

Product Name: ASCs : Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells

CELLERIX S.A.

NULL

Not Recruiting

Female: yes
Male: yes

196

Phase 3

Czech Republic;Germany;Netherlands;Belgium;Spain;Austria

1583

EUCTR2009-009926-94-DK
(EUCTR)

26/03/2009

25/02/2009

Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy

Patients with Crohns diseases failing treatment with infliximab
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Remicade
Trade Name: Humira

Department of medical gastroenterology, Herlev Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

1584

EUCTR2008-002783-33-FR
(EUCTR)

23/03/2009

14/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1060

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Denmark;Estonia;Spain;Greece

1585

EUCTR2008-002784-14-FR
(EUCTR)

23/03/2009

14/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1586

EUCTR2008-000649-77-DE
(EUCTR)

11/03/2009

26/09/2008

A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI

Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2b

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria

1587

EUCTR2008-004919-36-SE
(EUCTR)

11/03/2009

11/12/2008

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0

Abbott

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2B

Denmark;Austria;Sweden

1588

EUCTR2008-002784-14-PT
(EUCTR)

06/03/2009

06/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece

1589

EUCTR2008-002783-33-PT
(EUCTR)

06/03/2009

06/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1590

NCT00820365
(ClinicalTrials.gov)

March 2009

9/1/2009

SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease

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 (IBD)

Drug: SC12267 (4SC-101)

4SC AG

NULL

Completed

18 Years

70 Years

Both

Phase 2

Bulgaria;Germany;Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1591

EUCTR2007-005455-42-NL
(EUCTR)

26/02/2009

18/09/2008

ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIAL

Crohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction.
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Budenofalk
Product Name: Budenofalk
INN or Proposed INN: BUDESONIDE
Trade Name: Kenacort
Product Name: Kenacort
INN or Proposed INN: TRIAMCINOLONE

University Medical Center Utrecht

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands

1592

EUCTR2008-002784-14-CZ
(EUCTR)

20/02/2009

31/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1593

EUCTR2008-003571-45-GB
(EUCTR)

18/02/2009

16/07/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Limited, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Not Recruiting

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

1594

EUCTR2008-002784-14-NL
(EUCTR)

18/02/2009

05/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden

1595

EUCTR2008-002783-33-NL
(EUCTR)

18/02/2009

05/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1596

EUCTR2008-000649-77-FR
(EUCTR)

16/02/2009

07/12/2009

Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2b

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria

1597

EUCTR2007-006494-90-CZ
(EUCTR)

11/02/2009

07/11/2008

Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Czech Republic;Canada;Belgium;Poland;United Kingdom

1598

EUCTR2008-000649-77-NL
(EUCTR)

06/02/2009

12/09/2008

Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2b

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria

1599

EUCTR2008-007329-38-IT
(EUCTR)

06/02/2009

21/01/2009

Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease

Patients with steroid-dependent Crohn?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
INN or Proposed INN: dexamethasone sodium phosphate

ERYDEL S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

184

Spain;Italy

1600

EUCTR2008-002783-33-BE
(EUCTR)

05/02/2009

14/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1601

NCT00245505
(ClinicalTrials.gov)

February 2009

26/10/2005

The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's Disease

The 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 Study

Crohn's Disease

Drug: Mesalazine (Mesalamine)

Ferring Pharmaceuticals

NULL

Terminated

18 Years

70 Years

Both

Phase 3

Sweden

1602

EUCTR2008-002783-33-AT
(EUCTR)

29/01/2009

28/10/2008

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

1603

EUCTR2006-005526-23-GB
(EUCTR)

29/01/2009

27/04/2009

Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2 - Plantain NSP in Crohn's disease

Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Provexis Plc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

1604

EUCTR2008-002784-14-MT
(EUCTR)

28/01/2009

25/11/2008

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece

1605

EUCTR2008-002100-26-BE
(EUCTR)

28/01/2009

31/07/2008

PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE

Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid

Ferring Pharmaceuticals A/S

NULL

Not Recruiting

Female: yes
Male: yes

510

France;Belgium;Denmark;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1606

EUCTR2008-002783-33-MT
(EUCTR)

28/01/2009

25/11/2008

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece

1607

EUCTR2008-002784-14-IS
(EUCTR)

27/01/2009

06/11/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1508

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden

1608

EUCTR2008-000649-77-ES
(EUCTR)

27/01/2009

29/10/2008

Estudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFI

Enfermedad de Crohn activa de moderada a grave
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria

1609

EUCTR2008-000649-77-GB
(EUCTR)

23/01/2009

03/10/2008

Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2b

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Austria

1610

EUCTR2008-004919-36-DK
(EUCTR)

23/01/2009

18/12/2008

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0

Abbott

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2B

Denmark;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1611

EUCTR2008-004919-36-BE
(EUCTR)

20/01/2009

14/11/2008

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0

Abbott

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2B

Belgium;Denmark;Austria;Sweden

1612

EUCTR2008-003571-45-CZ
(EUCTR)

20/01/2009

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Not Recruiting

Female: yes
Male: yes

136

Hungary;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy

1613

EUCTR2008-002783-33-BG
(EUCTR)

16/01/2009

13/01/2009

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1614

EUCTR2006-004814-41-GB
(EUCTR)

16/01/2009

07/03/2008

A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease

Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Trade Name: Humira 40 mg solution for injection in pre-filled pen
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

184

France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom

1615

EUCTR2008-002100-26-FR
(EUCTR)

16/01/2009

02/09/2008

PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo

Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid

Ferring Pharmaceuticals A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

510

Germany;United Kingdom;Denmark;Belgium;France;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1616

EUCTR2008-002784-14-BG
(EUCTR)

16/01/2009

12/01/2009

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1617

EUCTR2008-002784-14-SK
(EUCTR)

15/01/2009

28/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

1618

EUCTR2008-002783-33-SK
(EUCTR)

15/01/2009

28/10/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1619

EUCTR2008-002783-33-IS
(EUCTR)

13/01/2009

06/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden

1620

EUCTR2008-002783-33-EE
(EUCTR)

09/01/2009

27/10/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1621

EUCTR2007-001377-28-PT
(EUCTR)

09/01/2009

25/08/2008

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL

Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

1622

EUCTR2008-002784-14-IE
(EUCTR)

09/01/2009

28/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden

1623

EUCTR2008-002783-33-IE
(EUCTR)

09/01/2009

28/10/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1624

EUCTR2008-005903-25-DE
(EUCTR)

08/01/2009

03/11/2008

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

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

Bulgaria;Germany

1625

EUCTR2008-002100-26-GB
(EUCTR)

07/01/2009

19/08/2008

PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE

Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid

Ferring Pharmaceuticals A/S

NULL

Not Recruiting

Female: yes
Male: yes

510

Germany;United Kingdom;Denmark;Belgium;France;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1626

EUCTR2008-000649-77-BE
(EUCTR)

05/01/2009

20/10/2008

Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2b

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria

1627

NCT01429922
(ClinicalTrials.gov)

January 2009

29/8/2011

Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

Double 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 Remission

Crohns Disease

Drug: ZP1848

MDS Pharma Services

NULL

Completed

18 Years

50 Years

Both

Phase 1;Phase 2

United States

1628

NCT00844285
(ClinicalTrials.gov)

January 2009

13/2/2009

SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry

A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

Crohn's Disease

Drug: Cimzia

UCB Pharma

NULL

Completed

18 Years

N/A

All

3045

United States

1629

EUCTR2008-002783-33-LV
(EUCTR)

19/12/2008

31/10/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1630

EUCTR2008-002784-14-LV
(EUCTR)

19/12/2008

31/10/2008

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2200

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1631

EUCTR2008-004276-49-FR
(EUCTR)

18/12/2008

21/07/2008

Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

199

Phase 2a

United Kingdom;Netherlands;Belgium;France;Spain;Italy

1632

EUCTR2008-002783-33-DK
(EUCTR)

18/12/2008

07/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden

1633

EUCTR2008-003571-45-NL
(EUCTR)

17/12/2008

25/11/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Not Recruiting

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

1634

EUCTR2007-002716-26-EE
(EUCTR)

17/12/2008

11/12/2007

A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria

1635

EUCTR2004-002163-24-GB
(EUCTR)

08/12/2008

17/02/2005

Crohn's Disease

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1636

NCT00801125
(ClinicalTrials.gov)

December 2008

1/12/2008

Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy

A Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy

Crohn's Disease

Drug: natalizumab

Biogen

Elan Pharmaceuticals

Withdrawn

18 Years

N/A

Both

Phase 4

NULL

1637

NCT01378390
(ClinicalTrials.gov)

December 2008

21/6/2011

Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease

Randomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease

Complex Perianal Fistula;Crohn Disease

Drug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: Placebo

Tigenix S.A.U.

NULL

Terminated

18 Years

N/A

All

Phase 3

Austria;Netherlands;Spain

1638

NCT00774982
(ClinicalTrials.gov)

December 2008

16/10/2008

Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients

Pilot, Randomized, Open-Label, Two-Way Crossover Comparative Bioavailability Study of 40 mg Delayed Release Oral 6Mercaptopurine Versus 100 mg Purinethol in Patients With Crohns Disease

Crohns Disease

Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine

Teva GTC

NULL

Completed

18 Years

50 Years

Both

Phase 1

Israel

1639

NCT00805766
(ClinicalTrials.gov)

December 2008

9/12/2008

Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)

Crohn's Disease

Drug: TA-650

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

16 Years

75 Years

All

Phase 3

Japan

1640

NCT00783692
(ClinicalTrials.gov)

December 2008

31/10/2008

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: vedolizumab;Other: Placebo

Millennium Pharmaceuticals, Inc.

NULL

Completed

18 Years

80 Years

All

1116

Phase 3

United States;Canada;Puerto Rico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1641

NCT00771667
(ClinicalTrials.gov)

December 2008

10/10/2008

A 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 Therapy

A 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

Crohn's Disease

Drug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

Centocor, Inc.

NULL

Completed

18 Years

N/A

All

526

Phase 2

United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom

1642

EUCTR2008-002100-26-SE
(EUCTR)

27/11/2008

08/08/2008

PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE

Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid

Ferring Pharmaceuticals A/S

NULL

Not Recruiting

Female: yes
Male: yes

510

Germany;United Kingdom;Denmark;Belgium;France;Sweden

1643

EUCTR2007-006494-90-BE
(EUCTR)

24/11/2008

18/08/2008

Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. K.G.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United Kingdom;Belgium;United States;Czech Republic;Canada;Poland

1644

EUCTR2008-003571-45-FR
(EUCTR)

21/11/2008

07/08/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

1645

EUCTR2008-000649-77-AT
(EUCTR)

20/11/2008

03/11/2008

Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2b

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1646

EUCTR2008-002100-26-DE
(EUCTR)

19/11/2008

06/03/2009

PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE

Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid

Ferring Pharmaceuticals A/S

NULL

Not Recruiting

Female: yes
Male: yes

510

France;Belgium;Denmark;Germany;United Kingdom;Sweden

1647

EUCTR2008-003571-45-IT
(EUCTR)

18/11/2008

22/09/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - ND

CP-690,550 is being developed for the treatment of patients with moderate-to-severe Crohn?s disease, as defined by a baseline Crohn?s Disease Activity Index (CDAI) score of 220 to 450 inclusive.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Code: CP -690,550
Product Name: CP -690,550
Product Code: CP -690,550

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

1648

EUCTR2008-004276-49-GB
(EUCTR)

12/11/2008

27/01/2009

Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

France;Belgium;Spain;Netherlands;Italy;United Kingdom

1649

EUCTR2008-003571-45-BE
(EUCTR)

05/11/2008

14/07/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Not Recruiting

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

1650

EUCTR2008-002100-26-DK
(EUCTR)

04/11/2008

18/08/2008

PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE

Active mild to moderate crohn's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: PENTASA Sachet
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid

Ferring Pharmaceuticals A/S

NULL

Not Recruiting

Female: yes
Male: yes

510

Germany;United Kingdom;Belgium;Denmark;France;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1651

NCT01559142
(ClinicalTrials.gov)

November 2008

19/3/2012

Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease

Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study

Crohn Disease

Drug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone)

Children's Memorial Health Institute, Poland

NULL

Active, not recruiting

7 Years

17 Years

Both

100

Phase 3

Poland

1652

NCT00752622
(ClinicalTrials.gov)

November 2008

12/9/2008

Treatment With Infliximab in a Medical Setting (Study P05587)

Optimization of Treatment With Infliximab in a Medical Setting

Crohn's Disease

Biological: Infliximab 5 mg/kg;Biological: Infliximab 5 mg/kg every 6 weeks;Biological: Infliximab 7 mg/kg every 8 weeks

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

100

Phase 4

Canada

1653

EUCTR2008-004926-18-DE
(EUCTR)

30/10/2008

Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP

Moderate to severe Crohn’s disease

Trade Name: Humira
Trade Name: Remicade

IBD Center LMU Munich

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

1654

EUCTR2006-003371-13-CZ
(EUCTR)

29/10/2008

11/05/2007

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

709

Phase 3

United Kingdom;Germany;Czech Republic;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1655

EUCTR2008-003571-45-HU
(EUCTR)

29/10/2008

05/08/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Not Recruiting

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1656

EUCTR2008-003571-45-ES
(EUCTR)

15/10/2008

01/08/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP-690,550 EN SUJETOS CON ENFERMEDAD DE CROHN DE MODERADA A GRAVE

Enfermedad de Crohn
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy

1657

EUCTR2008-004276-49-NL
(EUCTR)

14/10/2008

05/08/2008

Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

199

Phase 2a

United Kingdom;Netherlands;Belgium;France;Spain;Italy

1658

EUCTR2008-003571-45-SK
(EUCTR)

13/10/2008

23/09/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE

CROHN’S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: CP -690,550
Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 2

France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Netherlands;Italy;United Kingdom

1659

EUCTR2008-004276-49-BE
(EUCTR)

07/10/2008

15/09/2008

Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

France;Spain;Belgium;Netherlands;United Kingdom;Italy

1660

NCT00808262
(ClinicalTrials.gov)

October 2008

12/12/2008

Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease

A Phase I/II, Open-label, Escalating Dose, Optimal Two-stage, Study of TNFa-Kinoid (TNF- K) Immunization in Crohn's Disease Patients

Crohn's Disease

Biological: TNFa Kinoid

Neovacs

NULL

Completed

18 Years

65 Years

Both

Phase 1;Phase 2

South Africa;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1661

EUCTR2008-003167-39-BE
(EUCTR)

17/09/2008

28/08/2008

Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn.

Crohn' disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: diflucan
INN or Proposed INN: FLUCONAZOLE

Cliniques Universitaires Saint Luc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

1662

EUCTR2008-004276-49-ES
(EUCTR)

16/09/2008

18/07/2008

Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave.

Enfermedad de Crohn activa de moderada a grave
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: Laquinimod Cápsulas 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt

Teva Pharmaceutical Industries Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

199

United Kingdom;Netherlands;Belgium;France;Spain;Italy

1663

EUCTR2007-001913-41-AT
(EUCTR)

10/09/2008

18/06/2008

A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1664

EUCTR2008-004276-49-IT
(EUCTR)

08/09/2008

04/08/2008

Crohn Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns

Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: Laquinimod

Teva Pharmaceutical Industries Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2a

United Kingdom;Netherlands;Belgium;France;Spain;Italy

1665

EUCTR2007-001377-28-DE
(EUCTR)

01/09/2008

15/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1666

NCT00736983
(ClinicalTrials.gov)

September 2008

15/8/2008

Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's

Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin

Crohn's Disease With Perianal Fistulas

Drug: adalimumab;Drug: ciprofloxacin

Foundation for Liver Research

NULL

Completed

18 Years

70 Years

Both

Phase 3

Netherlands

1667

EUCTR2007-001913-41-DE
(EUCTR)

27/08/2008

20/03/2008

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1668

EUCTR2007-002716-26-AT
(EUCTR)

08/08/2008

18/06/2008

Clinical study to assess the long term safety of certolizumab pegol, administered at weeks 0, 2 and 4 and every 4 weeks thereafter, in patients with Crohn's disease and who participated in a previous study encoded C87085

Crohn`s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Australia;Latvia;Germany;New Zealand

1669

NCT00584740
(ClinicalTrials.gov)

August 2008

21/12/2007

Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease

Crohn's Disease

Drug: AIN457;Drug: Placebo

Novartis Pharmaceuticals

NULL

Terminated

18 Years

75 Years

All

Phase 2

Germany;Canada;United States

1670

EUCTR2006-004814-41-NL
(EUCTR)

24/07/2008

22/01/2008

Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

184

United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1671

EUCTR2007-001377-28-NL
(EUCTR)

15/07/2008

29/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

1672

EUCTR2006-004784-58-FR
(EUCTR)

07/07/2008

24/06/2008

An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.

Crohn's disease

Trade Name: Selective Immunosuppressive agents
Product Name: Remicade 100 mg
INN or Proposed INN: infliximab

CHRU de Lille

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Belgium;France

1673

NCT00715117
(ClinicalTrials.gov)

July 2008

14/7/2008

The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

Crohn's Disease

Drug: Naltrexone;Other: Placebo, sugar pill

Milton S. Hershey Medical Center

NULL

Completed

6 Years

17 Years

All

Phase 2

United States

1674

EUCTR2007-001377-28-AT
(EUCTR)

26/06/2008

27/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

1675

EUCTR2007-001377-28-FR
(EUCTR)

11/06/2008

29/02/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1676

EUCTR2007-000189-19-IT
(EUCTR)

10/06/2008

17/10/2008

Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: ITF 2357

ITALFARMACO

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands;Belgium;Italy

1677

NCT00707512
(ClinicalTrials.gov)

June 2008

27/6/2008

CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Crohn's Disease

Drug: natalizumab

Biogen

NULL

Terminated

18 Years

N/A

Both

N/A

United States;Puerto Rico

1678

EUCTR2006-004784-58-DE
(EUCTR)

27/05/2008

11/03/2008

Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: remicade
Product Name: remicade
INN or Proposed INN: INFLIXIMAB

University of Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Belgium;France

1679

EUCTR2006-004814-41-IT
(EUCTR)

19/05/2008

13/03/2008

A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND

Moderate to severe Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: HUMIRA
INN or Proposed INN: Adalimumab
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

184

United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy

1680

EUCTR2008-001131-35-NL
(EUCTR)

14/05/2008

29/05/2008

Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial

this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months

Trade Name: Remicade
Product Name: Infliximab
Product Code: EU/1/99/116/003
Trade Name: Imuran
Product Name: Azathioprine
Product Code: RVG 05565

Academic Medical Center, department of Gastroenterology and hepatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1681

NCT00686374
(ClinicalTrials.gov)

May 1, 2008

27/5/2008

Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

Crohn's Disease

Biological: Adalimumab

AbbVie (prior sponsor, Abbott)

NULL

Completed

7 Years

18 Years

All

100

Phase 3

Belgium;Canada;Czech Republic;Czechia;France;Netherlands;Poland;United Kingdom;United States

1682

NCT01297907
(ClinicalTrials.gov)

May 2008

24/1/2011

Bronchial Hyperreactivity in Children With Crohn Disease

Crohn's Disease

Other: Methacholine Challenge Test;Other: Fractional Exhaled NO (FENO);Other: Blood Test;Other: PCDAI

Rambam Health Care Campus

NULL

Completed

6 Years

25 Years

Both

N/A

Israel

1683

NCT00672763
(ClinicalTrials.gov)

May 2008

2/5/2008

Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease

Crohn's Disease

Drug: Colecalciferol D3 (Vigantol Oil);Drug: Medium chain triglycerides

Imperial College London

NULL

Withdrawn

18 Years

N/A

Both

Phase 4

United Kingdom

1684

EUCTR2008-001467-10-GB
(EUCTR)

30/04/2008

28/03/2008

Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3

Ulcerative colitis - in remissionCrohn's Disease - in remission
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease

Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom

1685

EUCTR2008-001466-93-GB
(EUCTR)

30/04/2008

28/03/2008

Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2

Active Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1686

EUCTR2007-001913-41-CZ
(EUCTR)

14/04/2008

07/04/2008

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3b

Hungary;Finland;Germany;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria

1687

EUCTR2007-006692-37-GB
(EUCTR)

10/04/2008

25/01/2008

The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit

IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 4

United Kingdom

1688

EUCTR2007-002716-26-CZ
(EUCTR)

07/04/2008

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

Estonia;Hungary;Czech Republic;Finland;Belgium;Austria;Latvia;Italy

1689

EUCTR2006-003371-13-IE
(EUCTR)

03/04/2008

05/02/2007

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

906

Phase 3

France;Czech Republic;Poland;Belgium;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom

1690

EUCTR2006-004814-41-CZ
(EUCTR)

12/03/2008

01/06/2007

Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

184

United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1691

EUCTR2007-002716-26-IT
(EUCTR)

04/03/2008

12/02/2008

A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND

Crohn?s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria

1692

EUCTR2007-001913-41-IT
(EUCTR)

04/03/2008

12/02/2008

Crohn?s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celletech

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1693

NCT00552058
(ClinicalTrials.gov)

March 2008

18/10/2007

Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

Crohn Disease

Biological: certolizumab pegol (CDP870, CZP);Other: Placebo

UCB Pharma

NULL

Completed

18 Years

75 Years

All

439

Phase 3

United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Czechia;Estonia;Finland;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Czech Republic;Spain

1694

NCT01487759
(ClinicalTrials.gov)

March 2008

6/12/2011

Prebiotic Effect on Metabolites in Crohn's Disease

Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients

Crohn Disease

Dietary Supplement: Oligofructose enriched inulin;Dietary Supplement: Maltodextrin

Katholieke Universiteit Leuven

NULL

Completed

18 Years

N/A

Both

N/A

Belgium

1695

EUCTR2007-004269-16-GB
(EUCTR)

28/02/2008

26/03/2008

Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children

Growth failure in children with Crohn's disease

Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection

Queen Mary, University of London

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1696

EUCTR2006-003371-13-PL
(EUCTR)

27/02/2008

30/11/2007

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

709

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1697

EUCTR2007-001913-41-EE
(EUCTR)

11/02/2008

11/12/2007

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1698

EUCTR2007-003239-21-FR
(EUCTR)

05/02/2008

15/01/2008

A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol (rINN)
Other descriptive name: Anti TNF humanized antibody Fab fragment-PEG conjugate

UCB PHARMA S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3b

France

1699

EUCTR2007-001913-41-BE
(EUCTR)

23/01/2008

13/11/2007

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1700

EUCTR2007-002716-26-BE
(EUCTR)

22/01/2008

16/10/2007

Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085

A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085.

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3b

United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Romania;Australia;Latvia;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1701

EUCTR2006-004814-41-BE
(EUCTR)

21/01/2008

01/06/2007

Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

184

United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy

1702

EUCTR2007-001014-17-DE
(EUCTR)

07/01/2008

03/03/2008

A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease

Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Rifaximin -EIR

Alfa Wassermann S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

424

Phase 2

France;Hungary;Germany;Italy

1703

NCT00517296
(ClinicalTrials.gov)

January 2008

15/8/2007

Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

EUS Guided Treatment With Humira for Crohn's Perianal Fistulas

Crohn Disease;Rectal Fistula

Procedure: EUA with seton placement if necessary;Drug: adalimumab;Procedure: EUS

Vanderbilt University Medical Center

NULL

Completed

18 Years

N/A

All

Phase 4

United States

1704

NCT00615199
(ClinicalTrials.gov)

January 2008

14/1/2008

A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.

Crohn's Disease

Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

139

Phase 2

United States;Belgium;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom

1705

NCT02185183
(ClinicalTrials.gov)

January 2008

28/4/2014

Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)

Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD

Crohn's Disease

Drug: Alequel

Hadassah Medical Organization

NULL

Completed

18 Years

70 Years

All

Phase 1;Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1706

EUCTR2007-002716-26-LV
(EUCTR)

20/12/2007

05/11/2007

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

Czech Republic;Estonia;Hungary;Finland;Belgium;Austria;Latvia;Italy

1707

EUCTR2007-001913-41-LV
(EUCTR)

20/12/2007

05/11/2007

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1708

EUCTR2007-002716-26-HU
(EUCTR)

18/12/2007

31/10/2007

Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085

A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085.

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3b

Australia;Latvia;Germany;New Zealand;United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania

1709

EUCTR2007-001913-41-HU
(EUCTR)

18/12/2007

31/10/2007

Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3b

Finland;Hungary;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1710

EUCTR2007-002716-26-FI
(EUCTR)

12/12/2007

16/10/2007

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1711

EUCTR2007-001913-41-FI
(EUCTR)

12/12/2007

16/10/2007

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3b

Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria

1712

NCT00619489
(ClinicalTrials.gov)

December 2007

11/2/2008

Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease

Ulcerative Colitis;Crohn's Disease

Drug: vedolizumab

Millennium Pharmaceuticals, Inc.

NULL

Completed

18 Years

75 Years

All

Phase 2

Canada

1713

EUCTR2005-003337-40-IT
(EUCTR)

19/11/2007

30/12/2008

Autologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTIC

Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Trade Name: THYMOGLOBULINE
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)

WOLFSON DIGESTIVE DISEASES CENTRE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United Kingdom;Italy

1714

NCT00562887
(ClinicalTrials.gov)

November 2007

21/11/2007

Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.

Crohn's Disease

Biological: Placebo;Biological: ABT-874

Abbott

NULL

Terminated

18 Years

74 Years

Both

246

Phase 2

United States;Australia;Austria;Belgium;Canada;Denmark;Puerto Rico;Germany

1715

NCT00358683
(ClinicalTrials.gov)

November 2007

28/7/2006

A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease

Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study.

Crohn's Disease

Drug: Certolizumab pegol

UCB Pharma

NULL

Withdrawn

18 Years

N/A

Both

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1716

EUCTR2007-001014-17-HU
(EUCTR)

16/10/2007

19/06/2007

Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Rifaximin -EIR
INN or Proposed INN: Rifaximin

Alfa Wassermann S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

424

Phase 2

Hungary;Germany;France;Italy

1717

EUCTR2005-003827-38-AT
(EUCTR)

15/10/2007

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

400

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden

1718

NCT00774969
(ClinicalTrials.gov)

October 2007

16/10/2008

Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease

Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease

Perianal Crohns'

Drug: Metronidazole

S.L.A. Pharma AG

NULL

Completed

18 Years

65 Years

Both

Phase 1

United Kingdom

1719

NCT00792740
(ClinicalTrials.gov)

October 2007

14/11/2008

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

Crohn's Disease

Drug: ITF2357;Drug: Placebo capsules

Italfarmaco

NULL

Terminated

18 Years

88 Years

Both

Phase 1;Phase 2

Belgium

1720

EUCTR2005-003827-38-FR
(EUCTR)

20/09/2007

23/07/2007

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Bulgaria;France;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1721

EUCTR2005-003827-38-BE
(EUCTR)

19/09/2007

26/07/2007

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

400

Hungary;Czech Republic;United Kingdom;Denmark;Belgium;France;Bulgaria;Austria;Sweden

1722

EUCTR2005-003827-38-SE
(EUCTR)

19/09/2007

11/07/2007

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

400

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden

1723

NCT00543374
(ClinicalTrials.gov)

September 17, 2007

11/10/2007

Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Crohn's Disease

Drug: Placebo;Drug: PROCHYMAL adult human mesenchymal stem cells

Mesoblast, Inc.

NULL

Completed

18 Years

70 Years

All

Phase 3

United States;Canada

1724

NCT00482092
(ClinicalTrials.gov)

September 17, 2007

30/5/2007

Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

Crohn's Disease

Drug: adult human mesenchymal stem cells;Drug: Placebo

Mesoblast, Inc.

NULL

Completed

18 Years

70 Years

All

330

Phase 3

United States;Australia;Canada;New Zealand

1725

NCT00528073
(ClinicalTrials.gov)

September 2007

10/9/2007

Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease

A Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's Disease

Crohn's Disease

Drug: Rifaximin -EIR

Alfa Wassermann S.p.A.

NULL

Completed

18 Years

75 Years

Both

410

Phase 2

France;Germany;Hungary;Israel;Italy;Poland;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1726

EUCTR2006-003371-13-GB
(EUCTR)

16/08/2007

22/01/2007

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006).

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

906

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1727

EUCTR2007-000189-19-BE
(EUCTR)

16/08/2007

03/08/2007

Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease

Moderate-to-severe active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Code: ITF2357

Italfarmaco S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands;Belgium;Italy

1728

EUCTR2006-004814-41-FR
(EUCTR)

07/08/2007

21/05/2007

Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

184

United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy

1729

EUCTR2007-000189-19-NL
(EUCTR)

06/08/2007

14/06/2007

Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease

Moderate-to-severe active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Code: ITF2357

Italfarmaco S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands;Belgium;Italy

1730

EUCTR2007-001014-17-FR
(EUCTR)

26/07/2007

01/06/2007

Treatment of moderate, active Crohn’s disease: induction of remission.
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Rifaximin -EIR

Alfa Wassermann S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

424

Phase 2

Hungary;Germany;France;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1731

EUCTR2007-001014-17-IT
(EUCTR)

26/07/2007

24/10/2007

moderate active Crohn disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: NORMIX *AD 12CPR RIV 200MG
INN or Proposed INN: Rifaximin

ALFA WASSERMANN

NULL

Not Recruiting

Female: yes
Male: yes

424

Phase 2

Hungary;Germany;France;Italy

1732

EUCTR2006-003371-13-DE
(EUCTR)

17/07/2007

14/12/2006

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

709

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1733

NCT00513552
(ClinicalTrials.gov)

July 2007

6/8/2007

Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

Crohn's Disease

Drug: Rifabutin , Clarithromycin, and Clofazimine

Medstar Health Research Institute

NULL

Withdrawn

18 Years

90 Years

All

Phase 4

United States

1734

EUCTR2006-004784-58-BE
(EUCTR)

22/06/2007

11/04/2007

Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: remicade
Product Name: remicade
INN or Proposed INN: INFLIXIMAB

University of Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Belgium;France

1735

EUCTR2006-001729-24-ES
(EUCTR)

01/06/2007

Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study.

Pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Patients suffering from Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

250

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1736

JPRN-UMIN000004427

2007/06/01

01/11/2010

A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection

Crohn's disease

Non-infliximab arm:
Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).

Infliximab arm:
Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.

Lower GI disease, Hyogo College of Medicine

NULL

Complete: follow-up complete

16years-old

65years-old

Male and Female

Phase 2;Phase 3

Japan

1737

NCT00495521
(ClinicalTrials.gov)

June 2007

29/6/2007

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

Crohn's Disease

Drug: 4-Aminosalicylic acid extended release granules

Jacobus Pharmaceutical

NULL

Terminated

2 Years

18 Years

All

Phase 2

United States;Israel

1738

NCT00724529
(ClinicalTrials.gov)

June 2007

25/7/2008

Post Marketing Surveillance of Remicade

Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)

Crohn's Disease;Ankylosing Spondylitis

Biological: Infliximab

Janssen Korea, Ltd., Korea

NULL

Completed

N/A

Both

938

Korea, Republic of

1739

NCT00606346
(ClinicalTrials.gov)

May 31, 2007

21/1/2008

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases

Biological: Anti TNF therapy including infliximab;Drug: No Biologics

Janssen Biotech, Inc.

NULL

Active, not recruiting

1 Month

17 Years

All

4970

United States;Canada

1740

EUCTR2006-003371-13-NL
(EUCTR)

22/05/2007

19/01/2007

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006)

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

906

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1741

EUCTR2006-003371-13-FR
(EUCTR)

16/05/2007

29/12/2006

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

906

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1742

EUCTR2006-001729-24-IT
(EUCTR)

10/05/2007

26/06/2007

Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046

Patients suffering from Crohn's disease and having completed the C87042 study
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870

UCB PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

600

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1743

EUCTR2006-001729-24-NL
(EUCTR)

10/05/2007

18/04/2007

Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

250

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1744

EUCTR2006-001729-24-AT
(EUCTR)

09/05/2007

18/12/2006

Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2

Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A

NULL

Not Recruiting

Female: yes
Male: yes

250

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1745

EUCTR2006-001729-24-SE
(EUCTR)

25/04/2007

09/03/2007

Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2

Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

250

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1746

EUCTR2005-003977-25-DE
(EUCTR)

13/04/2007

05/03/2007

A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;Belgium

1747

EUCTR2006-003371-13-DK
(EUCTR)

03/04/2007

09/03/2007

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

709

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Ireland;Italy;Poland

1748

EUCTR2006-003371-13-BE
(EUCTR)

03/04/2007

24/01/2007

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).

Crohn's disease, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

709

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1749

NCT00307931
(ClinicalTrials.gov)

April 2007

24/3/2006

Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab

Crohn's Disease

Biological: Certolizumab pegol

UCB Pharma

NULL

Terminated

18 Years

N/A

All

Phase 3

Greece

1750

NCT00409682
(ClinicalTrials.gov)

April 2007

8/12/2006

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Biological: Adalimumab

Abbott

NULL

Completed

6 Years

17 Years

All

192

Phase 3

United States;Belgium;Canada;Czech Republic;France;Netherlands;Poland;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1751

EUCTR2005-003827-38-DE
(EUCTR)

15/03/2007

14/12/2006

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L.

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

400

France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden

1752

EUCTR2005-003827-38-HU
(EUCTR)

13/03/2007

22/12/2006

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

423

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden

1753

EUCTR2005-003827-38-BG
(EUCTR)

09/03/2007

01/03/2007

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

336

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden

1754

EUCTR2006-003371-13-IT
(EUCTR)

09/03/2007

14/07/2008

Crohn's Disease, NOS
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease

Product Name: abatacept
INN or Proposed INN: abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

906

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland

1755

JPRN-JapicCTI-070367

01/3/2007

A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease

A Multi-Center, Randomized, Double-Blind, Placebo-controlled study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease

Crohn's disease

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneous

Abbott Japan Co., Ltd.

Eisai Co., Ltd.

BOTH

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1756

EUCTR2006-002078-23-GR
(EUCTR)

27/02/2007

10/10/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

1757

EUCTR2006-001729-24-FR
(EUCTR)

22/02/2007

22/01/2007

Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2

Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1758

EUCTR2006-002078-23-GB
(EUCTR)

22/02/2007

09/10/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Slovakia;Greece;Finland;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Sweden

1759

EUCTR2006-001729-24-GB
(EUCTR)

14/02/2007

07/12/2006

Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

UCB S.A

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

1760

EUCTR2006-003871-11-DE
(EUCTR)

06/02/2007

26/10/2006

An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II

The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I).
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

352

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1761

EUCTR2006-002078-23-PT
(EUCTR)

06/02/2007

01/09/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1762

JPRN-JapicCTI-070366

01/2/2007

A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease

A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease

Crohn's disease

Abbott Japan Co., Ltd.

Eisai Co., Ltd.

BOTH

NULL

1763

EUCTR2005-003977-25-BE
(EUCTR)

31/01/2007

11/12/2006

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;Belgium

1764

EUCTR2004-001213-34-GB
(EUCTR)

30/01/2007

19/08/2008

Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD

moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401

Trade Name: Salofalk
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicyl acid
Trade Name: Budenofalk
INN or Proposed INN: budesonide

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

370

Czech Republic;United Kingdom

1765

EUCTR2006-006632-22-BE
(EUCTR)

26/01/2007

19/12/2006

Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial

Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: HUMIRA
Trade Name: REMICADE

University of Leuven, Division of Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1766

EUCTR2005-005363-28-HU
(EUCTR)

25/01/2007

25/09/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria

1767

EUCTR2006-001729-24-DE
(EUCTR)

16/01/2007

20/11/2006

Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol in patients suffering from Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

605

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1768

EUCTR2006-002078-23-FI
(EUCTR)

10/01/2007

31/08/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1769

EUCTR2006-002078-23-SE
(EUCTR)

10/01/2007

09/10/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira
Product Code: ABT Humira
Product Name: Humira pre-filled PEN
Product Code: ABT Humira

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1770

EUCTR2005-005363-28-AT
(EUCTR)

08/01/2007

10/01/2007

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1771

NCT00354367
(ClinicalTrials.gov)

January 2007

18/7/2006

Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.

Crohn Disease

Drug: Certolizumab pegol

UCB Pharma

NULL

Withdrawn

18 Years

N/A

Both

Phase 3

NULL

1772

NCT00427921
(ClinicalTrials.gov)

January 2007

26/1/2007

Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

Crohn's Disease

Biological: adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

304

Phase 3

United States

1773

NCT00356408
(ClinicalTrials.gov)

January 2007

25/7/2006

Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).

Crohn's Disease

Biological: Certolizumab pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

106

Phase 3

United States;Canada;Germany

1774

NCT00417690
(ClinicalTrials.gov)

January 2007

2/1/2007

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease

A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

Crohn's Disease

Drug: 4-Aminosalicylic acid;Drug: PASER placebo granules

Jacobus Pharmaceutical

NULL

Terminated

18 Years

65 Years

Both

Phase 2

United States;Israel

1775

EUCTR2006-002027-16-GR
(EUCTR)

12/12/2006

05/09/2006

Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.

Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab

Product Name: certolizumab pegol
Product Code: CDP870

UCB AE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1776

EUCTR2006-002078-23-DE
(EUCTR)

07/12/2006

22/09/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1777

NCT00417391
(ClinicalTrials.gov)

December 2006

28/12/2006

Phase II Study of RR110 in Patients With Active Crohn's Disease

Crohn's Disease

Drug: RR110 (Tamibarotene)

R&R Inc.

NULL

Completed

20 Years

N/A

Both

Phase 2

Japan

1778

NCT00406653
(ClinicalTrials.gov)

December 2006

1/12/2006

A Study of Abatacept in Patients With Active Crohn's Disease

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Crohn's Disease

Drug: abatacept;Drug: placebo

Bristol-Myers Squibb

NULL

Terminated

18 Years

N/A

All

451

Phase 3

United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;Argentina;Ireland;Korea, Republic of;Spain;United Kingdom

1779

NCT00409617
(ClinicalTrials.gov)

December 2006

8/12/2006

Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Biological: adalimumab

Abbott

NULL

Completed

18 Years

75 Years

All

945

Phase 3

Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Norway;Portugal;Slovakia;Spain;Sweden;Switzerland;United Kingdom;United States

1780

EUCTR2006-003870-88-DE
(EUCTR)

27/11/2006

29/09/2006

A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I

In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

352

Phase 3b

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1781

EUCTR2006-002078-23-FR
(EUCTR)

24/11/2006

29/09/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Product Name: Humira pre-filled PEN
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB

Abbott GmbH & Co. KG (Abbott)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1782

EUCTR2005-002319-26-HU
(EUCTR)

24/11/2006

23/03/2006

Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, pilot, four week, parallel-group, multicentre, phase II study

Crohn's disease

Product Code: AZD9056

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;Belgium;Austria

1783

EUCTR2006-002078-23-DK
(EUCTR)

24/11/2006

26/09/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1784

EUCTR2006-002078-23-ES
(EUCTR)

23/11/2006

19/06/2013

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave.

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).Enfermedad de Crohn moderada a grave.
MedDRA version: 16.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856

Trade Name: Humira
Product Name: Humira pre-filled PEN
Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Germany;Sweden

1785

EUCTR2006-002078-23-CZ
(EUCTR)

21/11/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1786

NCT00349752
(ClinicalTrials.gov)

November 2006

30/6/2006

Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.

Crohn's Disease

Biological: certolizumab pegol 400 mg;Other: Placebo

UCB Pharma

NULL

Terminated

18 Years

N/A

All

174

Phase 3

United States;Canada;Germany;Belgium

1787

EUCTR2005-005291-32-DE
(EUCTR)

24/10/2006

06/06/2006

A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.

Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

130

Germany;Netherlands;Belgium;Italy;Austria;Sweden

1788

EUCTR2006-002078-23-NO
(EUCTR)

23/10/2006

22/08/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

1789

EUCTR2006-001729-24-BE
(EUCTR)

18/10/2006

01/09/2006

Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1790

EUCTR2006-002078-23-BE
(EUCTR)

16/10/2006

16/08/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1791

EUCTR2006-002078-23-NL
(EUCTR)

12/10/2006

10/08/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab
Product Name: Humira pre-filled PEN
INN or Proposed INN: adalimumab

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

1792

EUCTR2005-000496-17-SE
(EUCTR)

06/10/2006

24/02/2005

Atorvastatin in moderat active Crohns disease

Crohn's disease is an idiopathic chronic inflammatory bowel disease thought to result from inappropriate and ongoing activation of the mucosal immune system driven by the presence of normal luminal flora. It may affect the hole gastrointestinal tract, from mouth to rectum, with symptoms such as diarrhea, weight lose, malabsorption, abdominal pain and fever.

Product Name: atorvastatin

Region Skåne

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

1793

NCT00333788
(ClinicalTrials.gov)

October 2006

2/6/2006

Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

Crohn's Disease

Biological: Certolizumab pegol (CDP870)

UCB Pharma

NULL

Completed

18 Years

N/A

All

233

Phase 3

United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom

1794

NCT00897312
(ClinicalTrials.gov)

October 2006

9/5/2009

Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease

Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics

Melanoma

Biological: infliximab;Biological: pegylated interferon alfa;Biological: ticilimumab;Drug: ribavirin;Other: high performance liquid chromatography;Other: laboratory biomarker analysis

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Terminated

N/A

Both

N/A

NULL

1795

NCT00573469
(ClinicalTrials.gov)

October 2006

13/12/2007

Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

Crohn's Disease

Drug: D9421-C, 9mg;Drug: D9421-C, 15mg;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

65 Years

All

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1796

NCT00454545
(ClinicalTrials.gov)

October 2006

29/3/2007

Atorvastatin in Moderate Active Crohns Disease

Crohns Disease

Drug: Atorvastatin

Skane University Hospital

NULL

Completed

18 Years

65 Years

Both

Phase 2

Sweden

1797

EUCTR2006-002494-48-GB
(EUCTR)

27/09/2006

18/09/2006

Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease

Active colonic Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon)

Trade Name: Viagra

University College London / University College London Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

1798

EUCTR2006-002078-23-AT
(EUCTR)

25/09/2006

04/10/2006

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Trade Name: Humira
Product Name: Humira pre-filled PEN

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece

1799

EUCTR2005-005291-32-IT
(EUCTR)

14/09/2006

13/12/2006

A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND

Crohn s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: HUMIRA *SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab

Abbott GmbH Co.KG

NULL

Not Recruiting

Female: yes
Male: yes

130

Germany;Netherlands;Belgium;Italy;Austria;Sweden

1800

NCT00353756
(ClinicalTrials.gov)

September 2006

17/7/2006

Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn’s Disease

A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn’s Disease

Crohn's Disease

Drug: C326, IL-6 Inhibitory Avimer protein

Avidia

NULL

Recruiting

18 Years

65 Years

Both

Phase 1

Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1801

EUCTR2005-005291-32-NL
(EUCTR)

23/08/2006

28/06/2006

Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

130

Germany;Netherlands;Belgium;Italy;Austria;Sweden

1802

EUCTR2005-005363-28-BE
(EUCTR)

22/08/2006

27/04/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria

1803

NCT00348283
(ClinicalTrials.gov)

August 2006

30/6/2006

Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Crohn's Disease

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

18 Years

75 Years

All

135

Phase 3

United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Sweden

1804

EUCTR2005-004104-37-ES
(EUCTR)

28/07/2006

11/05/2006

A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

1805

EUCTR2005-005291-32-SE
(EUCTR)

25/07/2006

12/06/2006

Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

130

Germany;Netherlands;Belgium;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1806

EUCTR2005-005291-32-BE
(EUCTR)

20/07/2006

03/05/2006

Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

130

Germany;Netherlands;Belgium;Italy;Austria;Sweden

1807

EUCTR2005-005363-28-GB
(EUCTR)

11/07/2006

17/01/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom

1808

NCT00287170
(ClinicalTrials.gov)

July 2006

2/2/2006

Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease

Pilot, Open-Label, Randomized, Parallel Group Study to Evaluate Clinical/ and Immunological Efficacy/Safety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CD

Crohn's Disease

Drug: Delayed Release 6MP or Calcitriol vs. Purinethol

Teva GTC

NULL

Completed

18 Years

75 Years

Both

Phase 1;Phase 2

Israel

1809

EUCTR2005-005291-32-AT
(EUCTR)

28/06/2006

Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

130

Germany;Netherlands;Belgium;Italy;Austria;Sweden

1810

EUCTR2005-004104-37-DK
(EUCTR)

15/06/2006

04/05/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Spain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1811

EUCTR2005-004104-37-SE
(EUCTR)

08/06/2006

21/04/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

1812

NCT00305409
(ClinicalTrials.gov)

June 2006

20/3/2006

Synbiotic Treatment in Crohn's Disease Patients

Crohn's Disease

Drug: Synbiotic (Synergy I / B.longum)

University of Dundee

NULL

Completed

18 Years

79 Years

Both

N/A

United Kingdom

1813

NCT00329537
(ClinicalTrials.gov)

June 2006

23/5/2006

Study of Sargramostim in Moderately to Severely Active Crohn's Disease

Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)

Crohn's Disease

Drug: Sargramostim (Leukine);Drug: Placebo

Genzyme, a Sanofi Company

NULL

Terminated

18 Years

N/A

Both

Phase 2

Japan

1814

NCT00338650
(ClinicalTrials.gov)

June 2006

19/6/2006

Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab

Crohn's Disease

Drug: adalimumab

Abbott

NULL

Completed

18 Years

75 Years

Both

1000

Phase 3

United States

1815

EUCTR2005-004104-37-AT
(EUCTR)

24/05/2006

04/04/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1816

EUCTR2005-004104-37-DE
(EUCTR)

19/05/2006

29/03/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

United Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden

1817

EUCTR2005-004104-37-GB
(EUCTR)

17/05/2006

17/03/2006

A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Spain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden

1818

EUCTR2005-005363-28-CZ
(EUCTR)

15/05/2006

18/04/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;United Kingdom;Czech Republic;Belgium;Austria

1819

EUCTR2005-005363-28-DE
(EUCTR)

02/05/2006

02/06/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Czech Republic;United Kingdom;Germany;Belgium;Austria

1820

EUCTR2005-003827-38-GB
(EUCTR)

02/05/2006

18/11/2005

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

598

Phase 2

France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1821

NCT00329420
(ClinicalTrials.gov)

May 2006

22/5/2006

Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)

A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals

Crohn's Disease

Biological: Certolizumab pegol

UCB Pharma

NULL

Completed

16 Years

64 Years

All

Phase 2

Japan

1822

NCT00329550
(ClinicalTrials.gov)

May 2006

22/5/2006

Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals

Crohn's Disease

Biological: Certolizumab pegol (CZP)

UCB Japan Co. Ltd.

NULL

Completed

16 Years

64 Years

All

Phase 2

Japan

1823

NCT00317369
(ClinicalTrials.gov)

May 2006

21/4/2006

A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease

Crohn Disease

Drug: OPC-6535(Tetomilast)

Otsuka Pharmaceutical Co., Ltd.

NULL

Terminated

16 Years

65 Years

Both

Phase 2

Japan

1824

EUCTR2005-002319-26-AT
(EUCTR)

05/04/2006

22/02/2006

Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study - POPCRON

Crohn's disease

Product Code: AZD9056

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;Belgium;Austria

1825

NCT00308581
(ClinicalTrials.gov)

April 2006

28/3/2006

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

Crohn's Disease

Biological: Certolizumab pegol;Other: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

539

Phase 3

United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1826

NCT00655733
(ClinicalTrials.gov)

April 2006

6/4/2008

Phase II Study of HMPL-004 in Subjects With Crohn's Disease

Double-blind, Randomized, Multicenter, Placebo-controlled Phase II Study of Efficacy and Safety of HMPL-004 in Subjects With Active Moderate Crohn's Disease

Crohn's Disease

Drug: HMPL-004;Drug: Placebo

Hutchison Medipharma Limited

NULL

Completed

18 Years

N/A

All

101

Phase 2

United States

1827

EUCTR2005-004104-37-BE
(EUCTR)

23/03/2006

27/01/2006

A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

1828

NCT00294112
(ClinicalTrials.gov)

March 13, 2006

17/2/2006

Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease

A Phase II, Open-label, Randomized Study to Evaluate the Safety and Efficacy of PROCHYMAL™ IBD (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects Experiencing Moderate-to-severe Crohn's Disease That is Refractory to Steroids and Immune Suppressants

Crohn's Disease

Drug: Prochymal™ adult human mesenchymal stem cells;Drug: adult human mesenchymal stem cells

Mesoblast, Inc.

NULL

Completed

18 Years

70 Years

All

Phase 2

United States

1829

EUCTR2005-005414-20-IT
(EUCTR)

06/03/2006

31/01/2006

Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD

Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis
MedDRA version: 6.1;Level: PT;Classification code 10021972

Trade Name: Thalidomide Pharmion
INN or Proposed INN: Thalidomide

ISTITUTO PER L INFANZIA BURLO GAROFOLO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

124

Italy

1830

NCT00291668
(ClinicalTrials.gov)

March 2, 2006

10/2/2006

Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease

Crohn's Disease

Biological: Certolizumab Pegol;Other: Placebo

UCB Pharma

NULL

Completed

16 Years

65 Years

All

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1831

NCT00306215
(ClinicalTrials.gov)

March 2006

21/3/2006

A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: CCX282-B

ChemoCentryx

NULL

Completed

18 Years

N/A

Both

436

Phase 2

Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;Netherlands;Poland;South Africa;Sweden;United Kingdom

1832

EUCTR2005-003827-38-DK
(EUCTR)

27/02/2006

07/12/2005

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

598

Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden

1833

EUCTR2005-003827-38-CZ
(EUCTR)

20/02/2006

15/12/2005

A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

Product Name: CCX282-B
Product Code: CCX282-B

ChemoCentryx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

400

Hungary;United Kingdom;Czech Republic;Belgium;Denmark;France;Bulgaria;Austria;Sweden

1834

EUCTR2005-003337-40-GB
(EUCTR)

13/02/2006

13/01/2006

Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC

Patients with Crohn's disease who have not responded to immunosupressant medication

Product Name: Cyclophosphamide
Product Code: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
Product Name: Filgrastim
Product Code: N/A
INN or Proposed INN: Filgrastim
Other descriptive name: N/A
Product Name: rabbit antithymocyte globulin
Product Code: rbATG
INN or Proposed INN: rabbit antithymocyte globulin
Other descriptive name: N/A
Product Name: Mesna
Product Code: N/A
INN or Proposed INN: mensa
Other descriptive name: N/A
Product Name: methyl prednisolone
Product Code: N/A
INN or Proposed INN: methyl prednisolone
Other descriptive name: N/A
Product Name: ciprofloxacin
Product Code: N/A
INN or Proposed INN: ciprofloxacin
Other descriptive name: N/A

European Group for Blood and Marrow Transplantation (EMBT)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

1835

NCT00286689
(ClinicalTrials.gov)

February 3, 2006

1/2/2006

Effects of Growth Hormone in Chronically Ill Children

Hurler Syndrome;Cerebral Palsy;Juvenile Rheumatoid Arthritis;Crohn Disease;HIV Infections

Drug: Growth Hormone;Procedure: Whole body Protein turnover;Procedure: DEXA scan

University of Texas Southwestern Medical Center

NULL

Withdrawn

3 Years

17 Years

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1836

NCT00297648
(ClinicalTrials.gov)

February 2006

27/2/2006

Mucosal Healing Study in Crohn's Disease (CD)

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

Crohn's Disease

Biological: Certolizumab pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

Phase 3

Belgium;France;Germany

1837

EUCTR2005-002857-29-HU
(EUCTR)

04/01/2006

18/08/2005

A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s Disease

Moderate to severe, active Crohn’s disease
MedDRA version: 3.2;Level: LLT;Classification code 10011401

Product Name: STA-5326 mesylate
Product Code: S38
Other descriptive name: STA-6838, STA-5326 m, S38

Synta Pharmaceutical Corporation

NULL

Not Recruiting

Female: yes
Male: yes

282

Hungary

1838

NCT00630643
(ClinicalTrials.gov)

January 2006

28/2/2008

NI-0401 in Active Crohn's Disease

A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease

Moderate to Severe Crohn's Disease

Biological: NI-0401 (anti-CD3 mAB);Drug: Placebo

NovImmune SA

NULL

Completed

18 Years

70 Years

Both

Phase 1;Phase 2

NULL

1839

NCT00295165
(ClinicalTrials.gov)

January 2006

21/2/2006

Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease

Crohn Disease

Drug: Sargramostim (Leukine);Drug: Placebo

Genzyme, a Sanofi Company

NULL

Terminated

18 Years

N/A

Both

Phase 3

United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine

1840

EUCTR2005-002319-26-BE
(EUCTR)

23/12/2005

13/12/2005

Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study

Crohn's disease

Product Code: AZD9056

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;Belgium;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1841

EUCTR2005-002319-26-DE
(EUCTR)

20/12/2005

28/10/2005

Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study

Crohn's disease

Product Code: AZD9056

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;Belgium;Austria

1842

EUCTR2004-002815-10-DE
(EUCTR)

12/12/2005

25/04/2005

Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

1843

JPRN-C000000300

2005/12/01

22/12/2005

Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -

Patients with Crohn's disease in active phase

Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.
Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 12 weeks.

Zeria Pharmaceutical Co.,LTD

NULL

Complete: follow-up complete

16years-old

64years-old

Male and Female

Phase 3

Japan

1844

JPRN-C000000301

2005/12/01

22/12/2005

Z-206 Phase III Clinical Trial-Investigation on the remission–maintaining effect in patients with Crohn's disease in remission phase-

Patients with Crohn's disease in remission phase

Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa
placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.

Zeria Pharmaceutical Co.,LTD.

NULL

Complete: follow-up complete

16years-old

64years-old

Male and Female

Phase 2;Phase 3

Japan

1845

NCT00571337
(ClinicalTrials.gov)

December 2005

25/7/2007

Stop Infliximab in Patients With Crohn's Disease

Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

Crohn Disease

Drug: Infliximab

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Completed

18 Years

N/A

Both

126

Phase 3

Belgium;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1846

NCT00250198
(ClinicalTrials.gov)

November 3, 2005

5/11/2005

The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease

A Randomized, Double-blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease

Crohn's Disease

Drug: STA-5326

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

18 Years

75 Years

All

Phase 2

United States

1847

NCT00838149
(ClinicalTrials.gov)

November 2005

5/2/2009

Effect of Glutamine on Intestinal Permeability in Crohn's Disease

Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial

Crohn's Disease

Dietary Supplement: Glutamine;Dietary Supplement: Whey protein

All India Institute of Medical Sciences, New Delhi

NULL

Completed

15 Years

60 Years

Both

Phase 1

India

1848

EUCTR2004-004387-72-AT
(EUCTR)

11/10/2005

09/06/2005

A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A

Crohn’s disease (CD) in patients with at least one perianal fistula.
MedDRA version: 7.1;Level: LLT;Classification code 10011401

Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Austria;Germany

1849

NCT00225810
(ClinicalTrials.gov)

October 2005

22/9/2005

A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease

Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s Disease

Crohn's Disease

Drug: Crohn's Disease

Ferring Pharmaceuticals

NULL

Completed

8 Years

18 Years

Both

Phase 4

Czech Republic

1850

EUCTR2005-002472-15-SE
(EUCTR)

22/09/2005

23/06/2005

The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A.

Mild to moderate active Crohn's disease
MedDRA version: 7.1;Level: PT;Classification code 10011401

Trade Name: Pentasa Sachet 1 g prolonged release granules
Product Name: Pentasa Sachet 1 g
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicylic acid

Ferring Laegemidler A/S

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1851

NCT00252369
(ClinicalTrials.gov)

September 2005

10/11/2005

Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.

Crohn's Disease

Drug: Infliximab;Procedure: Instillation of fibrin glue

Sheba Medical Center

NULL

Terminated

18 Years

90 Years

Both

N/A

Israel

1852

NCT00132184
(ClinicalTrials.gov)

September 2005

18/8/2005

Vitamin D Treatment for Crohn´s Disease

Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation

Crohns Disease

Drug: Vitamin D

University of Aarhus

NULL

Active, not recruiting

18 Years

90 Years

Both

110

Phase 2;Phase 3

Denmark

1853

NCT00130390
(ClinicalTrials.gov)

August 2005

12/8/2005

Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults

Crohn's Disease

Drug: Nitazoxanide;Other: Placebo

Romark Laboratories L.C.

NULL

Terminated

18 Years

N/A

Both

Phase 2

United States

1854

NCT00138840
(ClinicalTrials.gov)

August 2005

26/8/2005

Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease

A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's Disease

Crohn's Disease

Drug: STA-5326 mesylate

Synta Pharmaceuticals Corp.

NULL

Completed

18 Years

75 Years

Both

282

Phase 2

United States;Canada

1855

EUCTR2004-002815-10-GB
(EUCTR)

25/07/2005

26/05/2005

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Spain;Denmark;Austria;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1856

EUCTR2005-002048-25-SE
(EUCTR)

20/07/2005

07/06/2005

A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease.

Inflammatory Bowel Disease (IBD) is the comprehensive term for disorders involving chronic inflammation in the gastrointestinal tract, often the small intestine and colon. It is believed to be a disorder mediated by T lymphocytes that arise in genetically susceptible persons as a result of a breakdown in the regulatory constraints on mucosal immune responses to enteric bacteria. Evidence suggests that Th1 T cells play an important pathogenetic role in Crohn´s disease.
Level: PTClassification code 10011401

Product Name: rCTB-401
Other descriptive name: rCTB-401

SBL Vaccin AB

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

1857

EUCTR2004-002815-10-ES
(EUCTR)

18/07/2005

16/05/2006

moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine

Centocor B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

1858

EUCTR2004-002815-10-DK
(EUCTR)

07/07/2005

10/07/2008

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

1859

NCT00167882
(ClinicalTrials.gov)

July 2005

9/9/2005

The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels

Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease

Drug: 5-aminosalicylate (Pentasa, Ferring)

VU University Medical Center

NULL

Completed

18 Years

70 Years

Both

Phase 4

Netherlands

1860

EUCTR2004-004083-77-SK
(EUCTR)

29/06/2005

31/01/2005

A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease

Moderate active Crohn disease

Trade Name: Mesalazine EC 500 mg
Product Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Trade Name: Salofalk 500 mg
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine

Disphar International B.V.

NULL

Not Recruiting

Female: yes
Male: yes

436

Phase 3

Czech Republic;Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1861

EUCTR2005-001148-22-SK
(EUCTR)

27/06/2005

12/05/2005

A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable

Crohn's disease
MedDRA version: 7.1;Level: Low;Classification code 10011401

Trade Name: Certican
Product Name: Certican
Product Code: RAD001
INN or Proposed INN: Everolimus
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: Azathioprine

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Slovakia

1862

EUCTR2004-004388-31-DE
(EUCTR)

03/06/2005

07/01/2005

A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A

Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD).
MedDRA version: 7.1;Level: LLT;Classification code 10011401

Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Germany

1863

EUCTR2004-004387-72-DE
(EUCTR)

03/06/2005

07/01/2005

A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A

Crohn’s disease (CD) in patients with at least one perianal fistula.
MedDRA version: 7.1;Level: LLT;Classification code 10011401

Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Germany

1864

NCT00114465
(ClinicalTrials.gov)

June 2005

14/6/2005

VSL#3 Versus Placebo in Maintenance of Remission in Crohn's Disease

Randomized, Double-Blind, Placebo-Controlled Study of VSL#3 Versus Placebo in the Maintenance of Remission in Crohn's Disease

Crohn's Disease

Drug: VSL#3;Other: Placebo

Orphan Australia

NULL

Completed

18 Years

75 Years

Both

Phase 4

Australia

1865

EUCTR2004-002815-10-SE
(EUCTR)

24/05/2005

11/04/2005

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1866

EUCTR2004-002815-10-AT
(EUCTR)

04/05/2005

30/03/2005

moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

Spain;Denmark;Austria;Germany;United Kingdom;Sweden

1867

NCT00829595
(ClinicalTrials.gov)

May 2005

23/1/2009

Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis

Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM)

Cedars-Sinai Medical Center

NULL

Completed

18 Years

N/A

Both

N/A

United States

1868

NCT00509639
(ClinicalTrials.gov)

May 2005

30/7/2007

Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease

Phase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease Activity

Crohn's Disease

Drug: 10% Metronidazole Ointment

S.L.A. Pharma AG

NULL

Completed

18 Years

N/A

Both

Phase 3

United States;United Kingdom

1869

EUCTR2004-004854-19-SK
(EUCTR)

25/04/2005

09/02/2005

A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease

Crohn's disease

Product Name: ITF2357
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon

Italfarmaco S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Slovakia

1870

NCT00705471
(ClinicalTrials.gov)

April 2005

23/6/2008

Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources

Crohn Disease

Biological: Infliximab

Merck Sharp & Dohme Corp.

Centocor, Inc.

Terminated

18 Years

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1871

NCT00271947
(ClinicalTrials.gov)

April 2005

2/1/2006

Crohn's Disease Stem Cell Transplantation

Crohn's Disease Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard Therapy

Crohn's Disease

Biological: Autologous Stem Cell Transplantation

Northwestern University

NULL

Terminated

18 Years

55 Years

All

Phase 2

United States

1872

NCT00098111
(ClinicalTrials.gov)

April 2005

3/12/2004

Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease

A Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS)

Crohn's Disease

Drug: azathioprine

Massachusetts General Hospital

NULL

Terminated

14 Years

N/A

Both

Phase 3

United States

1873

EUCTR2004-002693-37-DE
(EUCTR)

14/03/2005

06/01/2005

A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2

Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents
MedDRA version: 7.1;Level: LLT;Classification code 10011401

Trade Name: UVADEX
INN or Proposed INN: methoxsalen

Therakos

NULL

Not Recruiting

Female: yes
Male: yes

Germany

1874

EUCTR2004-002163-24-IT
(EUCTR)

28/02/2005

15/06/2005

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Trade Name: HUMIRA *SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab

Abbott GmBH Co KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;Spain;Denmark;Germany;United Kingdom;Italy

1875

EUCTR2004-002934-20-BE
(EUCTR)

22/02/2005

08/07/2005

A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab

Crohn's Disease

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1876

EUCTR2004-002163-24-DE
(EUCTR)

09/02/2005

25/10/2004

A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.

Crohn's Disease

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;United Kingdom;Germany;Denmark;Spain;Italy

1877

EUCTR2004-003839-31-DK
(EUCTR)

05/02/2005

17/05/2005

A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354

Crohn's Disease (CD)

Product Name: natalizumab
Product Code: AN100226
INN or Proposed INN: natalizumab

Elan Pharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Denmark

1878

NCT00106314
(ClinicalTrials.gov)

January 2005

22/3/2005

An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease

A Randomized, Double-Blind, Multi-Center, Dose Response, Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Moderately Active Crohn's Disease

Crohn's Disease

Drug: Dehydroepiandrosterone [DHEA]

Inflabloc Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

Phase 2

United States;Canada

1879

EUCTR2004-002163-24-SE
(EUCTR)

30/12/2004

12/11/2004

Crohn's Disease

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

1880

EUCTR2004-002163-24-ES
(EUCTR)

17/12/2004

07/06/2005

A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn.

Crohn's Disease

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1881

EUCTR2004-001213-34-SK
(EUCTR)

16/12/2004

16/08/2005

moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401

INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

370

Phase 3

Czech Republic;Slovakia;United Kingdom

1882

EUCTR2004-004083-77-CZ
(EUCTR)

13/12/2004

02/12/2004

Moderate active Crohn disease

Product Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine

Disphar International B.V.

NULL

Not Recruiting

Female: yes
Male: yes

436

Czech Republic

1883

EUCTR2004-002693-37-AT
(EUCTR)

10/12/2004

05/11/2004

Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents
MedDRA version: 7.1;Level: LLT;Classification code 10011401

Trade Name: UVADEX
INN or Proposed INN: methoxsalen

Therakos

NULL

Not Recruiting

Female: yes
Male: yes

Austria;Germany

1884

NCT00206661
(ClinicalTrials.gov)

December 2004

12/9/2005

Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease

Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment Extension

Crohn Disease

Drug: Sargramostim (Leukine)

Genzyme, a Sanofi Company

NULL

Terminated

6 Years

16 Years

Both

Phase 1;Phase 2

United States

1885

EUCTR2004-002163-24-BE
(EUCTR)

25/11/2004

19/08/2005

Crohn's Disease

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & co. KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1886

EUCTR2004-002163-24-HU
(EUCTR)

23/11/2004

13/10/2004

Crohn's Disease

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott Laboratories

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

1887

EUCTR2004-002163-24-DK
(EUCTR)

16/11/2004

09/07/2008

Crohn's Disease

Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

960

Hungary;United Kingdom;Germany;Denmark;Spain;Italy

1888

EUCTR2004-001213-34-CZ
(EUCTR)

02/11/2004

moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401

INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

370

United Kingdom;Czech Republic

1889

NCT00101946
(ClinicalTrials.gov)

October 2004

18/1/2005

Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Drug: 683699

GlaxoSmithKline

NULL

Completed

18 Years

65 Years

Both

Phase 2

United States;Canada

1890

NCT00105300
(ClinicalTrials.gov)

October 2004

11/3/2005

Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

Crohn's Disease

Drug: Adalimumab

Abbott

NULL

Completed

18 Years

75 Years

Both

300

Phase 3

United States;Belgium;Canada;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1891

NCT00300118
(ClinicalTrials.gov)

September 2004

7/3/2006

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients

Crohn's Disease

Drug: budesonide;Drug: mesalazine

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

70 Years

Both

311

Phase 3

Germany

1892

NCT00206674
(ClinicalTrials.gov)

September 2004

13/9/2005

Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease

Crohn Disease

Drug: Sargramostim (Leukine);Drug: Placebo

Genzyme, a Sanofi Company

NULL

Completed

18 Years

N/A

Both

286

Phase 3

Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom

1893

NCT00195715
(ClinicalTrials.gov)

September 2004

13/9/2005

Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

Crohn's Disease

Biological: Adalimumab

Abbott

NULL

Completed

18 Years

75 Years

All

777

Phase 3

United States;Australia;Belgium;Canada;Denmark;France;Germany;Hungary;Italy;Netherlands;Poland;South Africa;Spain;Sweden;United Kingdom

1894

NCT00102921
(ClinicalTrials.gov)

August 2004

4/2/2005

Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn’s Disease

Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn’s Disease

Crohn Disease

Drug: CCX282-B

ChemoCentryx

NULL

Completed

18 Years

65 Years

Both

Phase 2

United States

1895

NCT00160524
(ClinicalTrials.gov)

July 2004

8/9/2005

A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032

Crohn's Disease

Biological: Certolizumab Pegol (CDP870)

UCB Pharma SA

NULL

Completed

18 Years

N/A

All

596

Phase 3

United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Georgia;Germany;Hong Kong;Hungary;Israel;Italy;Latvia;Lithuania;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Ukraine;Czech Republic;Tunisia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1896

NCT00206713
(ClinicalTrials.gov)

July 2004

13/9/2005

Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim

Crohn Disease

Drug: Sargramostim (Leukine);Drug: Placebo

Genzyme, a Sanofi Company

NULL

Terminated

18 Years

N/A

Both

264

Phase 3

United States

1897

NCT00265122
(ClinicalTrials.gov)

April 2004

13/12/2005

A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: Ustekinumab 90 mg;Drug: Ustekinumab 4.5 mg/kg;Drug: Placebo SC;Drug: Placebo IV

Centocor, Inc.

NULL

Completed

18 Years

N/A

All

131

Phase 2

United States;Belgium;Canada

1898

NCT00245947
(ClinicalTrials.gov)

April 2004

26/10/2005

Study Evaluating ERB-041 in Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease

Crohn's Disease

Drug: ERB-041

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Both

Phase 1

NULL

1899

NCT00308438
(ClinicalTrials.gov)

March 1, 2004

13/9/2005

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008

Crohn's Disease

Drug: Teduglutide (ALX-0600)

Shire

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Canada

1900

NCT00152425
(ClinicalTrials.gov)

February 2004

7/9/2005

Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).

A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870

Crohn's Disease

Drug: Certolizumab Pegol (CDP870)

UCB Pharma

NULL

Completed

18 Years

N/A

Both

392

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1901

NCT00224562
(ClinicalTrials.gov)

February 2004

14/9/2005

The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists

The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis

Drug: TNF-alpha antagonists

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

N/A

Both

N/A

France

1902

NCT00160706
(ClinicalTrials.gov)

February 2004

8/9/2005

A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

Crohn's Disease

Biological: Certolizumab Pegol (CDP870)

UCB Pharma SA

NULL

Completed

18 Years

N/A

All

310

Phase 3

United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Ukraine;Czech Republic

1903

NCT00088062
(ClinicalTrials.gov)

February 2004

19/7/2004

STA-5326 in Crohn's Disease Patients

A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450

Crohn's Disease

Drug: STA-5326

Synta Pharmaceuticals Corp.

NULL

Completed

18 Years

65 Years

Both

Phase 1;Phase 2

United States

1904

NCT00152490
(ClinicalTrials.gov)

December 2003

8/9/2005

A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease

Crohn's Disease

Drug: Certolizumab Pegol (CDP870)

UCB Pharma

NULL

Completed

18 Years

N/A

Both

604

Phase 3

NULL

1905

NCT00796250
(ClinicalTrials.gov)

November 1, 2003

21/11/2008

Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine

Crohn's Disease

Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1906

NCT00072839
(ClinicalTrials.gov)

October 2003

11/11/2003

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease

Crohn's Disease

Drug: ALX-0600;Drug: placebo;Drug: teduglutide 0.05;Drug: teduglutide 0.2 mg;Drug: Teduglutide 0.05 dose;Drug: teduglutide 0.1 mg dose

Shire

NULL

Completed

18 Years

N/A

Both

100

Phase 2

United States;Canada

1907

NCT00206596
(ClinicalTrials.gov)

July 2003

12/9/2005

Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease

Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease

Crohn Disease

Drug: Sargramostim (Leukine);Drug: Placebo

Genzyme, a Sanofi Company

NULL

Completed

18 Years

80 Years

Both

127

Phase 2

United States;Canada

1908

NCT00741910
(ClinicalTrials.gov)

July 2003

22/8/2008

Extension Study of Semapimod 60 mg IV x 3 Days

Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

Crohn's Disease

Drug: Semapimod

Ferring Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

Phase 2

United States;Germany;Israel;Netherlands

1909

NCT00705614
(ClinicalTrials.gov)

July 2003

23/6/2008

Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)

Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy

Crohn's Disease

Biological: Remicade

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

2662

N/A

NULL

1910

NCT00077779
(ClinicalTrials.gov)

July 2003

12/2/2004

Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Crohn's Disease

Drug: Adalimumab

Abbott

NULL

Completed

18 Years

75 Years

Both

854

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1911

NCT00056355
(ClinicalTrials.gov)

March 2003

10/3/2003

Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's Disease

A Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohn's Disease Who May Also Be Refractory or Intolerant to Immunosuppressants and/or Anti-Tumor Necrosis Factor Agen

Crohn Disease

Drug: UVADEX and UVAR XTS Photopheresis System

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

N/A

Both

Phase 1

United States

1912

NCT00206700
(ClinicalTrials.gov)

February 2003

13/9/2005

Open-label Trial of Leukine in Active Crohn's Disease

Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease

Crohn Disease

Drug: Sargramostim (Leukine)

Genzyme, a Sanofi Company

NULL

Terminated

18 Years

N/A

Both

378

Phase 2

United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom

1913

NCT00207675
(ClinicalTrials.gov)

February 2003

13/9/2005

A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease

A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.

Crohn Disease

Drug: infliximab

Centocor, Inc.

Centocor BV

Completed

6 Years

17 Years

Both

112

Phase 3

NULL

1914

NCT00613197
(ClinicalTrials.gov)

January 2003

15/1/2008

EPANOVA in Crohn's Disease, Study 1

A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.

Crohn's Disease

Drug: Epanova

Tillotts Pharma AG

NULL

Completed

18 Years

70 Years

Both

384

Phase 3

Belgium

1915

NCT00740103
(ClinicalTrials.gov)

December 2002

21/8/2008

Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease

Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo

Crohn's Disease

Drug: Semapimod

Ferring Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

119

Phase 2

United States;Belgium;Germany;Israel;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1916

NCT00739986
(ClinicalTrials.gov)

October 2002

20/8/2008

Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo

A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. Placebo

Crohn's Disease

Drug: Semapimod;Drug: Placebo

Ferring Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

152

Phase 2

United States;Belgium;Germany;Israel;Netherlands

1917

NCT00976690
(ClinicalTrials.gov)

October 2002

11/9/2009

Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

Crohn Disease

Drug: Azathioprine OR Mesalazine

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Completed

18 Years

N/A

Both

Phase 3

France

1918

NCT00074542
(ClinicalTrials.gov)

September 2002

15/12/2003

An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

Crohn's Disease

Drug: Epanova™ (Omega-3 Free Fatty Acids)

Tillotts Pharma AG

NULL

Completed

16 Years

N/A

Both

364

Phase 3

United States;Canada

1919

NCT00055497
(ClinicalTrials.gov)

August 2002

3/3/2003

Remission in Subjects With Crohn's Disease, 1 Year Phase

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease

Crohn's Disease

Biological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mg

Abbott

NULL

Completed

18 Years

75 Years

All

276

Phase 3

United States

1920

NCT01070303
(ClinicalTrials.gov)

August 2002

16/2/2010

Remission in Subjects With Crohn's Disease, Open Label Extension

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension

Crohn's Disease

Biological: Adalimumab 40 mg eow or ew

Abbott

NULL

Completed

18 Years

75 Years

All

177

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1921

NCT00275418
(ClinicalTrials.gov)

July 2002

10/1/2006

Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease

Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission

Crohn's Disease

Drug: beta carotene from Dunaliella algae

Bnai Zion Medical Center

NULL

Recruiting

17 Years

75 Years

Both

300

Phase 3

Israel

1922

NCT00038766
(ClinicalTrials.gov)

June 2002

5/6/2002

CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

Crohn Disease

Drug: semapimod;Drug: placebo

Ferring Pharmaceuticals

NULL

Terminated

18 Years

N/A

Both

Phase 2

United States

1923

NCT00048295
(ClinicalTrials.gov)

May 2002

29/10/2002

Alicaforsen (ISIS 2302) in Patients With Active Crohn’s Disease

ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn’s Disease

Crohn's Disease

Drug: Alicaforsen

Isis Pharmaceuticals

NULL

Active, not recruiting

12 Years

N/A

Both

150

Phase 3

Belgium;Czech Republic;Germany;Italy;Poland;Spain

1924

NCT00040521
(ClinicalTrials.gov)

April 2002

27/6/2002

Study Evaluating rhIL-11 in Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease

Crohn Disease;Inflammatory Bowel Disease

Drug: Recombinant Human Interleukin-11 (rhIL-11)

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

16 Years

N/A

Both

Phase 2

United States

1925

NCT00055523
(ClinicalTrials.gov)

April 2002

4/3/2003

A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Crohn's Disease

Drug: Adalimumab (D2E7)

Abbott

NULL

Completed

18 Years

75 Years

Both

300

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1926

NCT00446433
(ClinicalTrials.gov)

March 2002

7/3/2007

A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease

Crohn's Disease

Drug: CC -5013

Celgene Corporation

NULL

Completed

12 Years

75 Years

Both

Phase 2

United States;France;Israel;United Kingdom

1927

NCT00072943
(ClinicalTrials.gov)

March 2002

12/11/2003

A Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease

Crohn's Disease;Colitis;Intestinal Disease;Gastrointestinal Disease;Digestive System Disease

Drug: anti-Interferon-gamma monoclonal antibody

Facet Biotech

NULL

Completed

18 Years

70 Years

Both

175

Phase 2

United States;Canada

1928

NCT00032786
(ClinicalTrials.gov)

March 2002

3/4/2002

Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease

Crohn's Disease

Drug: natalizumab

Biogen

Elan Pharmaceuticals

Completed

18 Years

N/A

Both

Phase 3

NULL

1929

NCT00946946
(ClinicalTrials.gov)

February 2002

24/7/2009

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence

Crohn's Disease

Drug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placebo

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

70 Years

Both

Phase 3

Austria;Germany

1930

NCT00035503
(ClinicalTrials.gov)

January 2002

3/5/2002

Multicenter Trial For Patients With Acute Crohn's Disease

Crohn's Disease

Drug: etiprednol dicloacetate

Teva Branded Pharmaceutical Products, R&D Inc.

NULL

Completed

18 Years

N/A

Both

Phase 2

United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1931

NCT00304252
(ClinicalTrials.gov)

November 2001

14/3/2006

Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease

A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease

Crohn's Disease

Drug: Interferon beta -1a

EMD Serono

NULL

Terminated

18 Years

N/A

Both

192

Phase 2

Germany;Italy;Sweden;Switzerland;United Kingdom

1932

NCT00025805
(ClinicalTrials.gov)

October 23, 2001

25/10/2001

G-CSF to Treat Crohn's Disease

Granulocyte-Colony Stimulating Factor Treatment for Crohn's Disease: A Pilot Study Assessing Immune and Clinical Response

Crohn's Disease

Drug: G-CSF

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

18 Years

N/A

All

Phase 1

United States

1933

NCT02209792
(ClinicalTrials.gov)

October 2001

5/8/2014

Dose Finding Study of BIRB 796 BS in Patients With Moderate to Severe Crohn's Disease

A Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included.

Crohn Disease

Drug: Placebo;Drug: BIBR 796 BS, 5 mg;Drug: BIBR 796 BS, 20 mg

Boehringer Ingelheim

NULL

Terminated

18 Years

65 Years

Both

284

Phase 2

NULL

1934

NCT00048113
(ClinicalTrials.gov)

September 2001

24/10/2002

Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

ISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease

Crohn's Disease

Drug: Alicaforsen

Isis Pharmaceuticals

NULL

Completed

12 Years

N/A

Both

150

Phase 3

United States;Canada

1935

NCT00278577
(ClinicalTrials.gov)

April 2001

15/1/2006

Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease

Immune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease

CROHN'S DISEASE

Biological: Immune Ablation and Hematopoietic Stem Cell Support

Richard Burt, MD

NULL

Terminated

N/A

60 Years

Both

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1936

NCT00007163
(ClinicalTrials.gov)

December 2000

9/12/2000

Monoclonal Antibody Treatment of Crohn's Disease

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Safety Study of Two Parallel Dose Levels of Subcutaneously Administered Human Monoclonal Antibody to Interleukin-12 (J695) in Patients With Active Crohn's Disease

Crohn's Disease

Drug: J695

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

N/A

Both

Phase 1

United States

1937

NCT00207662
(ClinicalTrials.gov)

July 2000

13/9/2005

A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease

ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: infliximab or placebo

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

580

Phase 3

NULL

1938

NCT00207766
(ClinicalTrials.gov)

June 2000

13/9/2005

A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease

Crohn Disease

Drug: infliximab or placebo

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

306

Phase 3

NULL

1939

NCT00655135
(ClinicalTrials.gov)

February 2000

3/4/2008

Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients

Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease

Crohn's Disease

Drug: LDP-02;Drug: Placebo

Millennium Pharmaceuticals, Inc.

NULL

Completed

18 Years

80 Years

Both

185

Phase 2

NULL

1940

NCT00004941
(ClinicalTrials.gov)

July 1996

24/2/2000

Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Crohn's Disease

Drug: monoclonal antibody cA2

FDA Office of Orphan Products Development

Centocor, Inc.

Completed

18 Years

65 Years

Both

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1941

NCT00269841
(ClinicalTrials.gov)

May 1996

22/12/2005

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Crohn Disease

Drug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: Placebo

Centocor, Inc.

NULL

Completed

18 Years

65 Years

Both

Phase 3

NULL

1942

NCT00004423
(ClinicalTrials.gov)

December 1995

18/10/1999

Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

Crohn's Disease

Drug: -aminosalicylic acid

University of Vermont

NULL

Completed

18 Years

80 Years

Both

N/A

NULL

1943

NCT00269854
(ClinicalTrials.gov)

June 1995

22/12/2005

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease

A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease

Crohn Disease

Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: Placebo

Centocor, Inc.

NULL

Completed

18 Years

65 Years

Both

108

Phase 2;Phase 3

NULL

1944

EUCTR2015-001924-40-PL
(EUCTR)

29/03/2017

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

798

Phase 3

1945

EUCTR2017-002231-41-FR
(EUCTR)

15/12/2017

A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1946

EUCTR2014-004354-34-Outside-EU/EEA
(EUCTR)

27/02/2015

Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease

A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals

Crohn’s Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL

UCB Japan Co., Ltd.

NULL

Female: yes
Male: yes

Japan

1947

EUCTR2014-004400-30-Outside-EU/EEA
(EUCTR)

27/02/2015

Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42)

A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals

Trade Name: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL

UCB Japan Co., Ltd.

NULL

Female: yes
Male: yes

Japan

1948

EUCTR2011-003743-22-DE
(EUCTR)

20/10/2011

A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: budesonide

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

United States;Canada;Poland;Germany;Italy

1949

EUCTR2017-004294-14-IE
(EUCTR)

27/04/2018

Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Female: yes
Male: yes

485

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

1950

EUCTR2015-001925-18-NO
(EUCTR)

27/01/2016

A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1064

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1951

EUCTR2017-000576-29-IE
(EUCTR)

10/04/2018

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1032

Phase 3

1952

EUCTR2014-004531-39-Outside-EU/EEA
(EUCTR)

12/11/2014

A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.

A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

Abbott Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Japan

1953

JPRN-JapicCTI-111460

29/03/2011

Phase II Study of Z-206 in Patients with Active Crohn's Disease

Active Crohn's disease

Intervention name : Z-206
INN of the intervention : Mesalazine
Dosage And administration of the intervention : oral

Zeria Pharmaceutical Co., Ltd.

Kyowa Hakko Kirin Co., Ltd.

BOTH

Phase 2

NULL

1954

EUCTR2017-000575-88-PL
(EUCTR)

20/06/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

1032

Phase 3

United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan

1955

EUCTR2017-000617-23-IE
(EUCTR)

10/04/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

983

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1956

EUCTR2014-004132-20-Outside-EU/EEA
(EUCTR)

28/07/2016

Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japan

A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan

Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Entocort
Product Code: D9421-C
INN or Proposed INN: budesonide
Trade Name: Pentasa
INN or Proposed INN: mesalazine

AstraZeneca K.K.

NULL

Female: yes
Male: yes

112

Phase 3

Japan

1957

EUCTR2014-004399-42-Outside-EU/EEA
(EUCTR)

05/03/2015

Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

Trade Name: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL

UCB Japan Co., Ltd.

NULL

Female: yes
Male: yes

100

Phase 2

Japan

1958

EUCTR2017-004295-55-IE
(EUCTR)

27/04/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Female: yes
Male: yes

1200

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand

1959

EUCTR2006-004814-41-Outside-EU/EEA
(EUCTR)

07/02/2012

Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Female: yes
Male: yes

184

NULL

1960

EUCTR2010-022383-12-DE
(EUCTR)

02/11/2010

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

750

Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1961

EUCTR2016-003123-32-NL
(EUCTR)

10/08/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

855

Phase 3

1962

EUCTR2016-003190-17-PL
(EUCTR)

01/08/2017

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

579

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

1963

JPRN-JapicCTI-121765

A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan

Crohn's Disease

Intervention name : D9421-C
Dosage And administration of the intervention : 9mg, Oral once daily
Control intervention name : Mesalazine
Dosage And administration of the control intervention : 1g, Oral three times a day

AstraZeneca

NULL

BOTH

Phase 3

NULL

1964

EUCTR2017-000575-88-CZ
(EUCTR)

25/04/2018

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

1032

Phase 3

Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan

1965

EUCTR2019-000333-39-FR
(EUCTR)

04/10/2019

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Millennium Pharmaceuticals, Inc (MPI)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1966

EUCTR2010-022382-10-NO
(EUCTR)

23/11/2010

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

Subjects with Moderately-to-Severely Active Crohn’s Disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Slovakia;Spain;Austria;United Kingdom;Italy;Czech Republic;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden

1967

EUCTR2020-003193-48-NL
(EUCTR)

21/11/2020

A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.

A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease.

Complex Perianal Fistulas in Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Alofisel
Product Name: Darvadstrocel
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)

Takeda Development Center Americas, Inc.

NULL

Female: yes
Male: yes

Phase 3

Spain;Poland;Israel;Netherlands;Japan;Italy

1968

EUCTR2007-006494-90-Outside-EU/EEA
(EUCTR)

07/02/2012

Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

Abbott GmbH & Co. K.G.

NULL

Female: yes
Male: yes

100

Belgium;Canada;Czech Republic;Poland;United Kingdom;United States

1969

EUCTR2019-000176-41-DE
(EUCTR)

15/08/2019

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy

1970

EUCTR2016-001956-22-FR
(EUCTR)

23/01/2017

A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease

A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Moderately to severely active Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Female: yes
Male: yes

Phase 1

United States;France;Canada;Poland;Belgium;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1971

EUCTR2011-000854-44-NL
(EUCTR)

06/07/2011

A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat several hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but neither the doctor nor the patient will knowduring the study.

A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease

Product Name: TRK-170
Product Code: TRK-170
Product Name: TRK-170
Product Code: TRK-170

Toray Industries Inc

NULL

Not Recruiting

Female: yes
Male: yes

609

Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Netherlands;Sweden

1972

EUCTR2016-003123-32-NO
(EUCTR)

16/11/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

855

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

1973

EUCTR2016-003123-32-CZ
(EUCTR)

19/07/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

855

Phase 3

1974

EUCTR2015-002882-41-AT
(EUCTR)

05/11/2015

A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease

Sono-Response-StudyA Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease

Inflammatory bowel disease (Crohn's disease)
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: SonoVue
Product Name: SonoVue
INN or Proposed INN: sulphur hexafluoride
Other descriptive name: SULFUR HEXAFLUORIDE

Medical University of Vienna (MUW)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

1975

EUCTR2016-000522-18-FR
(EUCTR)

21/06/2016

Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: humira
INN or Proposed INN: ADALIMUMAB
Product Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Methotrexate
Product Name: methotrexate

PIBDNet

NULL

Female: yes
Male: yes

312

Phase 4

France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1976

EUCTR2016-000522-18-PL
(EUCTR)

04/04/2018

Risk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

PIBDnet (Pediatric Inflammatory Bowel Disease Network)

NULL

Female: no
Male: no

312

Phase 4

France;Hungary;Czech Republic;Canada;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom

1977

EUCTR2011-003742-40-DE
(EUCTR)

20/10/2011

A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: BUDESONIDE

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Poland;Germany;Italy

1978

EUCTR2019-004225-24-GB
(EUCTR)

25/11/2020

A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease

A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr

Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Female: yes
Male: yes

Phase 3

United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom

1979

EUCTR2017-004295-55-CZ
(EUCTR)

05/02/2018

Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease

Celgene International II Sàrl

NULL

Female: yes
Male: yes

1350

Phase 3

1980

EUCTR2019-004225-24-DE
(EUCTR)

17/11/2020

Janssen-Cilag International NV

NULL

Female: yes
Male: yes

Phase 3

United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1981

EUCTR2017-000574-11-CZ
(EUCTR)

01/11/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

2453

Phase 3

Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands

1982

EUCTR2014-004381-24-Outside-EU/EEA
(EUCTR)

02/03/2015

The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents

A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) - NURTURE

Trade Name: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: Certolizumab Pegol

UCB Celltech

NULL

Female: yes
Male: yes

100

Phase 2

United States;Australia;Canada;New Zealand

1983

EUCTR2017-000617-23-PL
(EUCTR)

20/06/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

983

Phase 3

1984

EUCTR2014-004560-38-Outside-EU/EEA
(EUCTR)

12/11/2014

The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease.

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

Abbott Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Japan

1985

JPRN-JapicCTI-080566

09/04/2008

A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

Crohn's Disease

Intervention name : Budesonide
Dosage And administration of the intervention : Oral

AstraZeneca

NULL

BOTH

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1986

EUCTR2016-003191-50-NO
(EUCTR)

16/11/2017

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

1987

EUCTR2012-005226-29-NL
(EUCTR)

08/03/2013

Antibiotic therapy for children with active Crohn's disease

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: azithromycin
Trade Name: metronidazole
Product Name: metronidazole

Wolfson Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United States;Canada;Israel;Netherlands

1988

EUCTR2018-004346-42-PL
(EUCTR)

01/08/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Allergan Ltd.

NULL

Female: yes
Male: yes

2000

Phase 2;Phase 3

United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany

1989

EUCTR2017-003649-10-PL
(EUCTR)

11/12/2017

Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Female: yes
Male: yes

Phase 1

United States;Belgium;Spain;Poland;Germany;United Kingdom

1990

EUCTR2010-023589-39-HU
(EUCTR)

26/05/2011

Iron deficiency anaemia in quiescent Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1991

EUCTR2017-004292-31-IE
(EUCTR)

27/04/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand

1992

EUCTR2016-003123-32-PL
(EUCTR)

02/08/2017

A 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 of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

855

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand

1993

EUCTR2017-004293-33-DE
(EUCTR)

06/02/2018

Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl

NULL

Female: yes
Male: yes

600

Phase 3

1994

EUCTR2010-019996-32-NL
(EUCTR)

27/07/2011

A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective and safe for treating adult subjects with moderate to severe Crohn's Disease

A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’ TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005

Moderate to severe Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 2

France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Germany;Netherlands

1995

EUCTR2006-002078-23-SK
(EUCTR)

11/09/2006

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease

Moderate to severe Crohn´s Disease (Harvey Bradshaw index score greater or equal to 7)

Trade Name: HUMIRA

Abbott GmbH & Co. KG (Abbott)

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1996

EUCTR2017-000617-23-CZ
(EUCTR)

25/04/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

983

Phase 3

1997

EUCTR2017-000574-11-PL
(EUCTR)

05/12/2017

Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

2453

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1998

EUCTR2015-004121-13-Outside-EU/EEA
(EUCTR)

17/11/2015

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie GK

NULL

Female: yes
Male: yes

Japan

1999

EUCTR2019-001866-14-GB
(EUCTR)

09/04/2020

Open-label Extension Study of Brazikumab in Crohn’s Disease

An Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598

AstraZeneca AB

NULL

Female: yes
Male: yes

1000

Phase 3

United States;Czechia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of

2000

EUCTR2016-003191-50-PL
(EUCTR)

03/08/2017

Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1250

Phase 3

Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand