DDrare: Database of Drug Development for Rare Diseases

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	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
2	EUCTR2017-003649-10-BE (EUCTR)	02/05/2018	27/02/2018	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	60	Phase 1	United States;Poland;Spain;Belgium;Germany;United Kingdom
3	EUCTR2017-003649-10-DE (EUCTR)	30/04/2018	07/02/2018	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	Not Recruiting			Female: yes Male: yes	60	Phase 1	United States;Poland;Belgium;Spain;Germany;United Kingdom
4	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	24	Phase 1	Belgium;Poland;Spain;United Kingdom;Germany;United States
5	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
6	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	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
7	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
8	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	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
9	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	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
10	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]	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	1250	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
11	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]	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	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
12	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	Crohn`s Disease MedDRA version: 20.0;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
13	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]	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	1250	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
14	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	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	1250	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
15	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	Crohn`s Disease MedDRA version: 20.0;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	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
16	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	Crohn`s Disease MedDRA version: 20.0;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
17	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]	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;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
18	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	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
19	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	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
20	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]	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	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
21	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	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;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
22	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
23	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
24	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]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	Roche Farma S.A en nombre de F. Hoffmann-La Roche 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
25	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]	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;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
26	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	Crohn`s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	Roche Farma S.A. en nombre de F. Hoffmann-La Roche 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
27	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]	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	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
28	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
29	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	Crohn`s Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche 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
30	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	Crohn`s Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche 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
No.	TrialID	Date_ enrollment	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	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]	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	1250	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
32	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	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
33	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	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;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
34	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	Crohn`s Disease MedDRA version: 20.0;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;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden
35	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2017-003649-10-PL (EUCTR)		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]		F. Hoffmann-La Roche Ltd	NULL	NA			Female: yes Male: yes	60	Phase 1	United States;Belgium;Spain;Poland;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

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

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

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

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

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

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

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

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

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-003649-10-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