DDrare: Database of Drug Development for Rare Diseases

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

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

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2012-002030-37-BE (EUCTR)	08/01/2013	05/09/2012	A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Crohn’s Disease (CD) and Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
2	EUCTR2010-024638-48-BG (EUCTR)	26/09/2012	03/10/2012	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210		Portugal;United States;Serbia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
3	EUCTR2010-023437-30-BG (EUCTR)	18/09/2012	17/07/2012	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA	Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
4	EUCTR2010-023437-30-PL (EUCTR)	06/06/2012	08/05/2012	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA	Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240		Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden
5	EUCTR2010-024638-48-PL (EUCTR)	04/06/2012	09/05/2012	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United States	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.	TrialID	Date_ enrollment	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	NCT01387594 (ClinicalTrials.gov)	May 2012	30/6/2011	Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs	A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)	Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis	Procedure: lumbar puncture;Drug: lumbar puncture	Shire	NULL	Completed	18 Years	75 Years	All	49	Phase 1	Austria;Belgium;France;Germany;Netherlands
7	EUCTR2010-024638-48-BE (EUCTR)	19/03/2012	25/05/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
8	EUCTR2010-024638-48-DE (EUCTR)	22/02/2012	30/05/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
9	EUCTR2010-024638-48-NO (EUCTR)	31/01/2012	01/06/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210		Portugal;Serbia;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden
10	EUCTR2010-023437-30-NO (EUCTR)	01/12/2011	01/06/2011	Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA	Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240		Portugal;Germany;Netherlands;Norway;France;Austria;South Africa;Sweden;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2010-023437-30-DE (EUCTR)	16/11/2011	26/05/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA	Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240		United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
12	EUCTR2010-023437-30-NL (EUCTR)	11/11/2011	08/06/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's Disease	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA	Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240		Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden
13	EUCTR2010-024638-48-NL (EUCTR)	11/11/2011	08/06/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Canada;Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden;Korea, Republic of
14	EUCTR2010-023437-30-SK (EUCTR)	29/09/2011	11/05/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA) - OPERA	Crohn's Disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240		United States;Portugal;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Norway;Germany;Korea, Republic of;Sweden
15	EUCTR2010-024638-48-SK (EUCTR)	29/09/2011	11/05/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2010-024638-48-PT (EUCTR)	02/09/2011	26/05/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	210		Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
17	EUCTR2010-023437-30-PT (EUCTR)	02/09/2011	26/05/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA	Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden
18	EUCTR2010-024638-48-ES (EUCTR)	15/07/2011	18/11/2011	A7281007; Multi-center open-label extension study for PF-00547659	MULTICENTER OPEN-LABEL EXTENSION STUDY FOR PF-00547659(OPERA II) - OPERA II	Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: No aplicable Product Code: PF-00547659 INN or Proposed INN: No aplicable Other descriptive name: No aplicable	PFIZER, S.L.U.	NULL	Not Recruiting			Female: yes Male: yes	180		Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden
19	NCT01298492 (ClinicalTrials.gov)	July 1, 2011	26/1/2011	A Study To Monitor Long-Term Treatment With PF-00547659	A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II	Crohn's Disease	Drug: PF-00547659	Shire	NULL	Completed	18 Years	75 Years	All	268	Phase 2	United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden
20	EUCTR2010-023437-30-ES (EUCTR)	03/06/2011	13/06/2011	Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA	Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA	Enfermedad de Crohn Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders	Product Name: PF-00547659 Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: No aplicable	PFIZER SLU	NULL	Not Recruiting			Female: yes Male: yes	240		Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2010-024638-48-SE (EUCTR)	01/06/2011	25/05/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210		Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
22	EUCTR2010-023437-30-AT (EUCTR)	01/06/2011	25/05/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA	Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240		United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
23	EUCTR2010-024638-48-AT (EUCTR)	01/06/2011	25/05/2011	A7281007; Multi-center open-label extension study for PF-00547659	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II	Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden
24	EUCTR2010-023437-30-SE (EUCTR)	01/06/2011	25/05/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA	Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240		Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland
25	EUCTR2010-023437-30-BE (EUCTR)	27/05/2011	25/05/2011	Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA	Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	240		United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT01276509 (ClinicalTrials.gov)	April 6, 2011	12/1/2011	Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease	A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)	Crohn's Disease	Drug: PF-00547659 SC injection	Shire	NULL	Completed	18 Years	75 Years	All	265	Phase 2	United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-002030-37-BE
(EUCTR)

08/01/2013

05/09/2012

A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Crohn’s Disease (CD) and Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

EUCTR2010-024638-48-BG
(EUCTR)

26/09/2012

03/10/2012

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Crohn’s disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Portugal;United States;Serbia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

EUCTR2010-023437-30-BG
(EUCTR)

18/09/2012

17/07/2012

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Crohn's Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

EUCTR2010-023437-30-PL
(EUCTR)

06/06/2012

08/05/2012

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden

EUCTR2010-024638-48-PL
(EUCTR)

04/06/2012

09/05/2012

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Crohn’s disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01387594
(ClinicalTrials.gov)

May 2012

30/6/2011

Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs

A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)

Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis

Procedure: lumbar puncture;Drug: lumbar puncture

Shire

NULL

Completed

18 Years

75 Years

All

Phase 1

Austria;Belgium;France;Germany;Netherlands

EUCTR2010-024638-48-BE
(EUCTR)

19/03/2012

25/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

EUCTR2010-024638-48-DE
(EUCTR)

22/02/2012

30/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

EUCTR2010-024638-48-NO
(EUCTR)

31/01/2012

01/06/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Portugal;Serbia;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden

EUCTR2010-023437-30-NO
(EUCTR)

01/12/2011

01/06/2011

Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA

Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Portugal;Germany;Netherlands;Norway;France;Austria;South Africa;Sweden;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-023437-30-DE
(EUCTR)

16/11/2011

26/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

EUCTR2010-023437-30-NL
(EUCTR)

11/11/2011

08/06/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's Disease

Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden

EUCTR2010-024638-48-NL
(EUCTR)

11/11/2011

08/06/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Canada;Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden;Korea, Republic of

EUCTR2010-023437-30-SK
(EUCTR)

29/09/2011

11/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA) - OPERA

Crohn's Disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Norway;Germany;Korea, Republic of;Sweden

EUCTR2010-024638-48-SK
(EUCTR)

29/09/2011

11/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-024638-48-PT
(EUCTR)

02/09/2011

26/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

EUCTR2010-023437-30-PT
(EUCTR)

02/09/2011

26/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden

EUCTR2010-024638-48-ES
(EUCTR)

15/07/2011

18/11/2011

A7281007; Multi-center open-label extension study for PF-00547659

MULTICENTER OPEN-LABEL EXTENSION STUDY FOR PF-00547659(OPERA II) - OPERA II

Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: No aplicable
Product Code: PF-00547659
INN or Proposed INN: No aplicable
Other descriptive name: No aplicable

PFIZER, S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

180

Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

NCT01298492
(ClinicalTrials.gov)

July 1, 2011

26/1/2011

A Study To Monitor Long-Term Treatment With PF-00547659

A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

Crohn's Disease

Drug: PF-00547659

Shire

NULL

Completed

18 Years

75 Years

All

268

Phase 2

United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden

EUCTR2010-023437-30-ES
(EUCTR)

03/06/2011

13/06/2011

Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA

Enfermedad de Crohn Crohn's Disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: PF-00547659
Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: No aplicable

PFIZER SLU

NULL

Not Recruiting

Female: yes
Male: yes

240

Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-024638-48-SE
(EUCTR)

01/06/2011

25/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland

EUCTR2010-023437-30-AT
(EUCTR)

01/06/2011

25/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

EUCTR2010-024638-48-AT
(EUCTR)

01/06/2011

25/05/2011

A7281007; Multi-center open-label extension study for PF-00547659

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden

EUCTR2010-023437-30-SE
(EUCTR)

01/06/2011

25/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Portugal;Germany;Netherlands;Norway;France;Austria;Sweden;South Africa;Slovakia;Serbia;Canada;Belgium;Spain;United States;Croatia;Poland

EUCTR2010-023437-30-BE
(EUCTR)

27/05/2011

25/05/2011

Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA

Product Name: Not Applicable
Product Code: PF-00547659
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

240

United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01276509
(ClinicalTrials.gov)

April 6, 2011

12/1/2011

Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

Crohn's Disease

Drug: PF-00547659 SC injection

Shire

NULL

Completed

18 Years

75 Years

All

265

Phase 2

United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden