DDrare: Database of Drug Development for Rare Diseases

97. 潰瘍性大腸炎
［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］

Searched query = "Ulcerative colitis"
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 = (-)-3-(4-Aminophenyl)-2-methoxypropionic acid; (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid; (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride; -aminosalicylic acid; 0.25 mg RPC1063; 0.25mg RPC103; 0.25mg RPC1063; 0.5 mg RPC1063; 1 mg RPC1063; 1.0 mg RPC103; 1.0 mg RPC1063; 1.Remicade; 10 mg Natura-alpha capsule; 100; 100 mg; 150 mg; 1500mg mesalazine pellets; 15N2-tofacitinib; 2 x 10 mg Natura-alpha capsules; 2'-Fucosyllactose; 2-Hydroxybenzoic acid; 20 mg; 225mg SHP647 (PF-00547659); 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM); 25 mg Ontamalimab; 250mg mesalazine pellets; 2L polyethylene glycol/ascorbic acid; 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; 40 mg MSB11022; 42942019; 450 mg; 5 ASA, enemas, suppositories, corticosteroids; 5-ASA; 5-ASA (5-Aminosalicylate); 5-ASA MMx; 5-AminoSalicylic Acid; 5-Aminosalicyclic acid; 5-Aminosalicylic Acid; 5-Aminosalicylic acid; 5-Aminosalicylic acid (5-ASA); 5-Aminosalicylic acid(5-ASA) and/or Prednisone; 5-HTP; 5-amino salicylic acid; 5-amino salicylic acid (5-ASA); 5-amino-2-hydroxybenzoic acid; 5-aminosalicylate (Pentasa, Ferring); 5-aminosalicylic acid; 5-aminosalicylic acid (5-ASA); 50 mg; 500mg mesalazine pellets; 549-0261/F02-01; 6 mercaptopurine; 6-MP; 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid; 6-mercaptopurine; 75 mg Ontamalimab; 750mg mesalazine pellets; 75mg SHP647 (PF-00547659); 90 mg hydrocortisone acetate suppository with Sephure suppository applicator; A multistrain probiotic product (DSF); A07DA03; A: 1 dosis; AB (antibiotics); ABBV-006; ABBV-066; ABBV-323; ABBV-323 Dose A; ABBV-323 Dose B; ABI-M201; ABT-494; ABT-Humira; ABX464; ABX464 100mg; ABX464 25mg; ABX464 50mg; ADALIMUMAB; AEB071; AEB071A; AG011; AG011 - Capsules; AG011 - Enema; AJG501; AJG511; AJM300; ALLOPURINOL; ALTH12-1:4; ALTH12-2:4; AMG 181; AMG181; AMGEVITA; AMGEVITA (Adalimumab biosimilar ); AMGEVITA®; AMT; AMT-101; AMT-101 (oral); AND (Andrographolide); ANDROGRAPHIS PANICULATA; ANDROGRAPHIS PANICULATA (ethanol extract); AODG (Apigenin-7-O-glucuronide); APD334; APREMILAST; APRISO 375 mg extended-release capsules; APVO210; AR401959 L-arginine; AS; AS INN; ASA; ASACOL; ASC; ASP015K; ASP3291; AST-120; ATL-2502; AVONEX; AVX 470; AZA; AZAFOR 50mg; AZATHIOPRINE; AZATIOPRINA; AbGn-168H; Abalimumab; Abatacept; Abatacept (ABA); Abrilumab; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion; Acetate; Acetic acid; Acidophilus; Active group; Adalimumab; Adipate; Adipose derived, autologous mesenchymal stem cells; Adipose tissue-derived mesenchymal stem cells; Adipose-cord mesenchymal stromal cells (A-MSCs); Air; Aldesleukin; Alicaforsen; Alkaline Phosphatase; Allogeneic adipose tissue-derived mesenchymal stem cells; Allopurinol; AloASC; Aloe; Aloe Barbadensis Miller; Amg 181; Amgevita; Amgevita 40 mg Injektionslösung im Fertigpen; Amgevita 40 mg Injektionslösung in einer Fertigspritze; Amgevita 40Mg Solution for Injection; Aminosalicylic acid; Amitriptyline; Amitriptyline hydrochloride; Amoxicillin; Amoxicillin and tetracycline; Amoxicillin, metronidazole and tetracycline; Anakinra; Andecaliximab; AndoSan; Andrographolide; Anrukinzumab; Anti Beta7; Anti CD3 monoclonal antibody; Anti TNF therapy including infliximab; Anti-CD3; Anti-CD3 monoclonal antibody; Anti-IP-10 Antibody; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; Anti-MAdCAM antibody; Anti-TL1A; Anti-TNF Drug; Anti-TNF Therapy; Anti-TNF discontinuation: Physiological saline solution; Anti-TNF: Infliximab (Infusion); Anti-TNF:Adalimumab (Subcutaneus); Antibiotic cocktail; Apigenin; Apixaban; Apixaban 2.5 milligram; Apremilast; Apriso 0.375G ER CAP; Aquamin®; Arginine; Asacol; Asacol (mesalamine); Asacol (mesalamine) Delayed-release Tablets; Asacol 400 mg; Asacol 400 mg (mesalamine); Asacol 400 mg tablet; Asacol 400mg tablet; Asacol 800 mg (mesalamine); Asacol 800 mg tablet; Asacol 800mg tablet; Asacol Delayed Release Tablets; Asacol Delayed-Release Tablets; Asacol tablet; Asacol®; Asacol® 400 mg; Ascorbic Acid; Ascorbic acid; Aspergillus oryzae; Avonex; Azathioprine; Azathioprine (AZA); Azathioprine (AZA) or 6-mercaptopurine (6-MP); Azathioprine (Imuran) 50 mg Overencapsulated Tablet; Azathioprine and Allopurinol; Azathioprine or 6-mercaptopurine; Azatioprina; B2-ASmedic; B: 2 dosis; BBT-401-1S; BBT-401-1S, Multiple doses; BBT-401-1S, Single dose; BECLOMETASONE DIPROPIONATE; BG9418 (Interferon beta-1a); BG9924; BI 655130; BIAP; BITTER CANDYTUFT FRESH PLANT EXTRACT; BL-7040; BMS-188667; BMS-936557; BMS-986165; BMS-986165 Dose 1; BMS-986165 Dose 2; BMS-986166; BMS-986184; BMS986165; BRAZIKUMAB; BT-11; BT-11 (1000 mg); BT-11 (500 mg); BT-11 1000mg; BT-11 500 mg; BT-11 Active; BUDESONIDE; Bacteriotherapy; Balsalazide; Balsalazide Disodium; Balsalazide disodium; Baminercept; Band; Bascial prescription plus or minus herbs depend on symptoms; Basiliximab; Beclometasone; Beclometasone dipropionate; Beclomethasone dipropionate; Beclomethasone diproprionate; Behavioral: AbbVie Care 2.0; Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus); Behavioral: Increased dietary intake of salmon or cod; Behavioral: TIP / IMPACT Plus Care Coordination; Berberine; Berberine Chloride; Bertilimumab; Beta-1,3/1,6-D-Glucan; Bezlotoxumab; Bifidobacterium breve; Bifidobacterium infantis; Bifidobacterium infantis 35624; Bimekizumab; Bio-enhanced Curcumin Soft Gelatin Capsule; Biologically active human fecal microbiota; Biopsies; Biosimilar; Biosimilar infliximab; Bitterschleifenblume-ganzpflanze 1,5ml/10ml; Blood sample; Blood samples; Boulardii; Bovine intestinal alkaline phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase BIAP; Brazikumab; Broccoli; Budenofalk 2mg rectal foam; Budenofalk 3mg; Budenofalk rectal foam; Budenofalk® suppositories; Budenofalk® suppositories (BUS); Budesonide; Budesonide (6 mg); Budesonide (9 mg); Budesonide 6 mg capsules, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide 9 mg capsules, hard (BUX-PV); Budesonide 9 mg capsules, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide MMX; Budesonide MMX 6 mg Tablet; Budesonide MMX®; Budesonide MMX® 6 mg; Budesonide MMX® 9 mg; Budesonide-MMX; Budesonide-MMX®; Budesonide-MMX® 6 mg; Budesonide-MMX® 9 mg; Budesonide-MMX™; Butanoic acid; Butyrate; By demand; CANNABIDIOL; CARVI EXTRACTUM FLUIDUM; CAT-354; CB-01-02; CB-01-05-MMX; CC; CC-10004; CD; CGMP protein; CICLOSPORIN; CLA; CLA (Chlorogenic acid); CLIPPER*30CPR 5MG R.M.; CNTO 148; CNTO-148; CNTO1275; CNTO148; CNTO1959; CNTO312; COFFEE COAL; COLAL PRED; COLAL-PRED; COLAL-PRED®; CP; CP- 690 550; CP-690,500 5 mg; CP-690,550; CP-690,550 10 mg; CP-690,550-10; CP690,550; CS (corticosteroids) Only; CT-P13; CT-P13 SC (Infliximab); CYCLOSPORIN; CYCLOSPORINE VS INFLIXIMAB; Caffeine; Caffeine 100 mg; Calcitonin nasal spray (salmon); Calcium; Caltrate Pill; Cannabidiol; Cannabis; Cannabis, Medical; Carbon; Carbon dioxide; Carnitine; Carrageenan; Casein; Casein glycomacropeptide (CGMP); Catridecacog; Ceftriaxone; Cefuroxime; Certolizumab pegol; Chloride; Chlorogenic Acid; Cholecalciferol; Ciclosporin; Ciclosporina; Cimzia; Ciprofloxacin; Clarithromycin; Clipper; Clipper 30 cpr 5mg R.M.; Clotrimazole; Coamoxiclav; Cobitolimod; Coffee; Colal-Pred; Colazide; Coltect; Combination Oral Budesonide and Rectal Hydrocortisone; Combination Product: Beclomethasone dipropionate in addition to MC-EVOO; Combination Product: Beclomethasone dipropionate in addition to refined oil; Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator; Corticosteroid; Corticosteroids; Corticosteroids only; CortimentMMX 9 mg; CosmoFer; CosmoFer 50mg/ml solution for infusion or injection; Cotrimoxazole; Curcumin; CyCol; CyCol™; Cyclosporin; Cyclosporine; Cyclosporine (USAN); Cytochrome P450 (CYP) Substrates; D-Proline; DACORTIN; DAND (14-Deoxyandrographolide); DDAND (14-deoxy-11,12-didehydroandrographolide); DELTACORTENE FORTE*10CPR 25MG; DELTACORTENE*20CPR 5MG; DEXTRAN 1 FOR INJECTION; DIMS0150; DIMs0150; Daclizumab; Dacortin; Decortin H; Decortin H 1 mg; Decortin H 10mg; Decortin H 20mg; Decortin H 50 mg; Decortin H 5mg; Dekavil; Dekristol; Delayed and extended release mesalazine; Deligoparin; Delmitide acetate; Deltacortene; Deltacortene 10 cpr 25mg; Deltacortene 20 cpr 5mg; Dersalazina sodica; Dersalazine; Dersalazine sodium; Device: The Colonic Transendoscopic enteral Tubing.; Dexamethasone; Dexamethasone 21-phosphate; Dextran; Dextromethorphan; Dextromethorphan 30 mg; Diagnostic Test: Antibodies to golimumab; Diagnostic Test: Calprotectin; Diagnostic Test: Colonoscopy; Diagnostic Test: Golimumab trough levels; Diagnostic Test: Histology; Diagnostic Test: Rectosigmoidoscopy; Diagnostic Test: parasitological diagnostics (coproscopy); Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels; Diet; Doxycycline; Dukoral; E. coli Nissle; E6007; EGF enema; EMEA/H/C/000240; EMEA/H/C/000481; EN; ENTOCORT CR; ENTYVIO; ETROLIZUMAB; Ecologic 825; Eicosapentaenoic Acid; Eicosapentaenoic acid; Encapsulated Mesalamine Granules (eMG); Encapsulated faecal microbiota; Encapsulated faecal microbiota filtrate; Entecavir; Entocort EC® 3 mg; Entocort® CR; Entyvio; Entyvio 300 mg; Entyvio 300mg; Epaxal Berna (virosomal hepatitis A vaccine); Epidermal growth factor; Epidermal growth factor enema; Ergocalciferol; Ethanol; Etrasimod; Etrasimod L-arginine; Etrolizumab; Etrozulimab; Exposure to golimumab; F8IL10; FE 999301; FILGOTINIB; FITC-ADALIMUMAB; FITC-Adalimumab; FMT; FMT enema; FMT infusions; FMT oral; FP-110; FP-CYA-050; FP-CYA-053; Factor XIII; Faecal Microbiota Transplant; Faecal Microbiota Transplantation; Faecal matter; Fecal Microbial Transplant; Fecal Microbial Transplantation; Fecal Microbiota; Fecal Microbiota Enema; Fecal Microbiota Transplant; Fecal Microbiota Transplant (FMT); Fecal Microbiota Transplantation; Fecal Microbiota Transplantation (FMT); Fecal Microbiota Transplantation (FMT), OpenBiome; Fecal microbiota; Fecal microbiota capsule; Fecal microbiota transplantation; Ferric carboxymaltose; Ferrous sulphate; Filgotinib; Film-coated tablet; Flagyl; Flaxseed; Flaxseed lignan-enriched complex (FLC); Flixabi; Fluorescein; Flupentixol; Fosfomycin; Freeze-dried black raspberry powder; G321605; GB004; GED-0301; GED-0507-34-LEVO; GED-0507-34-Levo; GED-0507-34-Levo 160 mg; GED-0507-34-Levo 80 mg; GED0507; GI-270384; GLPG0974; GLPG1205; GLPG3970; GLYCYRRHIZA GLABRA ROOT; GOLIMUMAB; GS-4875; GS-5745; GS-5745 IV; GS-5745 SC; GS-6034; GSK1399686; GSK1605786; GSK1605786A; GSK2586184 400mg; GSK2831781; GSK2831781 IV infusion; GSK2831781 SC injection; GSK2982772; GSK2982772A, where A denotes the free base; GUSELKUMAB; GWP42003; Ganciclovir; Gastro-resistant phosphatidylcholine granules; Gelatin; Genetic: TPMT genotyping; Gliolan; Glutamine; Glycyrrhiza; Glycyrrhiza glabra; Gold; Golimumab; Golimumab (GLM); Golimumab (Optimization); Golimumab 1 mg per kg; Golimumab 100 mg; Golimumab 2 mg per kg; Golimumab 200 mg; Golimumab 4 mg per kg; Golimumab 400 mg; Golimumab 50 mg; Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg; Golimumab Dose 1; Golimumab Dose 2; Golimumab Liquid in Vial; Golimumab Liquid in prefilled syringe; Golimumab Prefilled Syringe; Golimumab treatment optimization.; Gralise; Granulated mesalamine; Grapefruit; Group 1- Control Diet; Group 2- UCD Diet; Guaiazulene; Guselkum; Guselkumab; Guselkumab Dose 1; Guselkumab Dose 2; H02AB; HE3286; HF2; HGS1025; HMPL-004; HMPL-004 1800 mg/day; HMPL-004 2400 mg/day; HMPL-004 high dose; HMPL-004 low dose; HMPL004-6599; HUMIRA; HUMIRA 40Mg Solution for Injection; HUMIRA ®; HYDROCORTISONE ACETATE; Hemay007; Hepatitis A Vaccine; Herbal treatment (SA100); Hextend; Hgd40; High Dose Budesonide; High dose; HuM291; HuM291); Hulio; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-IP10 monoclonal antibody; Human anti-TNF-alpha monoclonal antibody; Humanized recombinant IgG4 monoclonal antibody against CD-127; Humira; Humira (adalimumab original); Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg solution for injection in pre-filled syringes; Humira 40 mg/0.8 ml solution for injection; Humira 40 mg/0.8 ml solution for injection for paediatric use; Humira®; Hyaluronate; Hydrocortisone; Hydrocortisone acetate; Hydrocortisone sodium succinate; Hydrogen; Hydroxide; Hydroxocobalamin; Hydroxocobalamin with Butyrate; IBD98-M; IBD98-M Delayed-release Capsules; IDOFORM®Travel; IM90838; IMU-838; INCB039110; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN-2; ITACITINIB ADIPATE; IV Corticosteroid; Iberogast N; Imolope; Impact; Imuran; Imurek; Imurek 25mg Filmtabletten; Imurek 50mg Filmtabletten; Imurel; Inflectra; Inflectra 100 mg; Inflectra 100 mg powder for concentrate for solution for infusion; Infliximab; Infliximab (IFX); Infliximab 10 mg/kg; Infliximab 5 mg/kg; Infliximab [infliximab biosimilar 3]; Infliximab and adalimumab; Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab; Infliximab, adalimumab, certolizumab pegol; Innovator infliximab; Inositol; Interferon beta; Interferon beta-1a; Interferon-beta; Interferon-beta-1a; Interferon-beta-1a, 44 microgram; Interferon-beta-1a, 66 microgram; Interleukin 2; Interleukin-2 (aldesleukin).; Iron; Iron Sucrose; Iron sucrose; Iron sulphate; Iron sulphate 200mg coated tablets; Iron supplement 300-600 mg/day; Iron(III)- hydroxide dextran complex; Itacitinib; JNJ-54781532 150 mg once daily; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 75 mg twice daily; JNJ-54781532-AAD-10 mg; JNJ-54781532-AAD-30 mg; JNJ-54781532-AAD-5 mg; JNJ-66525433; K(D)PT; KHK4083; KRP203; KRP203A; Kamillenblüten 3ml/10ml; Kappaproct; KdPT; Kremezin; Kremezin®, Spherical Adsorptive Carbon; Kyo-Dophilus; Kümmel 2ml/10ml; L-Carnitine; L-Lysyl-D-Prolyl-L-Threonine Acetate; L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate; LC51-0255; LDP-02; LIXACOL; LOPERAMIDE; LT-02; LT-02 (modified-release PC pellets); LX1606; LY3074828; LYC-30937; LYC-30937-EC; LYS006; Lactated Ringers; Lactobacillus GG; Lactobacillus casei DG; Lactobacillus plantarum; Lactobacillus reuteri; Lactobacillus rhamnosus GG ATCC 53103; Lactobacillus salivarius UCC118; Lactobacilus acidophilus & bifidobacterium animalis/lactis; Lactose; Lactose in water; Leucine; Levocarnitine; Levocarnitine propyl hydrochloride; Linaclotide; Lixacol; Loperamide; Loperamide hydrochloride; Losartan; Low Dose Budesonide; Low FODMAP; Low dose; Low dose naltrexone; Lumbar puncture; Lysine; Lysine-D-Proline-Threonine; Lysine-D-proline-threonine; MATRICARIA FLOWER; MATRICARIA RECUTITA L. FLOS; MD-0901; MDX-1100; MDX-1100 (anti-CXCL10 human monoclonal antibody); MEDI7183 high dose; MEDI7183 low dose; MEDI7183 medium dose; MELISSAE FOLII DRY AQUEOUS EXTRACT; MENTHA × PIPERITA L. FOLIUM; MERCAPTOPURINE; MESALAZINA; MESALAZINE; MESENCHYMAL CELLS; MET-2; METHOTREXATE; METHOTREXATE DISODIUM; METHYLENE BLUE; METHYLPREDNISOLONE SODIUM HEMISUCCINATE; MEZAVANT; MIRIKIZUMAB; MK-8259; MLN0002; MLN0002 (Vedolizumab); MLN0002 SC; MLN002; MMX Mesalamine; MMX Mesalamine/Mesalazine; MMX Mesalamine/Mesalazine (High Dose); MMX Mesalamine/Mesalazine (Low Dose); MMX mesalamine/ mesalazine; MONOCLONAL ANTIBODY ANTI-IGG1; MSC; MTX; MTX 12.5; MTX 25; MYRRH; Magnesium; Magnesium citrate; Maltodextrin; Maltose; Mango; Mango polyphenolics; Mare´s milk; Matricaria Flower; Maximal oral 5ASA; Melatonin; Melissenblätter 15ml/10ml; Melitracen; Mercaptopurine; Mercaptopurine (Puri-Nethol); Mercaptopurine (Purinethol); Mesalamin; Mesalamine; Mesalamine Delayed Release Tablets 400mg; Mesalamine Enema; Mesalamine Granules; Mesalamine Once-Daily; Mesalamine Twice-Daily; Mesalamine granules; Mesalamine, 5-ASA; Mesalamine, 5-aminosalicylic acid [5-ASA]; Mesalazina; Mesalazine; Mesalazine (3,600 mg); Mesalazine (Asacol®); Mesalazine - TID 1000 mg; Mesalazine - TID 2x 500 mg; Mesalazine 1000 mg gastro-resistant tablets; Mesalazine 250Mg; Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet; Mesalazine 4G Enema; Mesalazine 500 mg gastro-resistant tablets (Salofa; Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg); Mesalazine Enema; Mesalazine enema; Mesalazine liquid enema; Mesalazine slow-release granules; Mesalazine tablet; Mesalazine with hydrocortisone sodium succinate; Mesalazinum; Mesenchymal Stromal Cells; Mesenchymal stromal cells; Methotrexate; Methotrexate bellon; Methotrexate bellon 25mg/ml; Methotrexate injection; Methylene blue; Methylene blue 25mg tablets; Methylprednisolone; Metoject; Metronidazole; Metronidazole capsule 50 mg; Mezavant; Mezavant 1200 mg magensaftresistente Retardtabletten; Mezavant Gastro-resistant, prolonged release tablets; Mezavant XL; Mezavant XL 1200 mg gastro-resistant prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.; Mezavant XL 1200mg gastro-resistant, prolonged release tablets; Mezavant XL Gastro-resistant, prolonged release tablets; Midazolam; Midazolam 2 mg; Mirikizumab; Mirikizumab IV; Mirikizumab SC; MitoQ; Modified Gegen Qinlian Decoction; Modified-release phosphatidylcholine; Mongersen; MultiStem; MultiStem high dose; MultiStem low dose; Multiple dose- Group B; Multiple dose-Group B; Multistem; Mycodigest supplement; Myrrh; Myrrhinil-Intest®; N.a.; NAND (Neoandrographolide); ND; NEORAL; NX-13 250 mg; Naltrexone; Nanocort; Neomycin; Neoral Soft Gelatin Capsules; Niclosamide; Nicolon; Nitazoxanide; Nitazoxanide 500Mg Oral Tablet; Nivolumab; Nolpitantium Besylate; Nolpitantium besylate; Non as of yet; None; None given; Normal Saline Enema; Null; Nutrition supplement; Nutritional dietary intervention; Nuvion®); OPC-6535; OPC-6535 Tablets (drug); OPC-6535(Tetomilast); OPRX-106; OPRX-106 (plant cells expressing TNFR-Fc) 2mg; OPRX-106 (plant cells expressing TNFR-Fc) 8mg; ORE1001; OSE-127; OST-122; Oats; Omeprazole; Omeprazole 20 mg; Ondansetron; Ondansetron hydrochloride dihydrate; Ontamalimab; Oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; Oral Corticosteroids; Oral OKT3; Orencia; Originator (legacy) drug; Oseltamivir; Other: 0 mg; Other: 100% pomegranate juice; Other: Additional Therapies; Other: Control; Other: Control group(Normal saline); Other: Conventional drugs; Other: Faecal bacterial transplantation; Other: Fast Mimicking Diet; Other: Hyperbaric Oxygen Therapy; Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis; Other: Intensify treatment with the existing drug; Other: Laboratory Biomarker Analysis; Other: Measurement of drug (Adalimumab/Infliximab); Other: Mesalazine; Other: Other Biologic Agents; Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA); Other: Saline; Other: Therapy Education; Other: Threonine; Other: Ulcerative Colitis Diet; Other: dietary intervention with no-carrageenan diet; Other: e-Monitoring; Other: pretreatment antibiotics; Overencapsulated Azathioprine (Imuran) 50 mg Tablet; Overencapsulated mesalazine tablets; Oxygen; Ozanimod; Ozanimod hydrochloride; PARNAPARIN SODIUM; PBF-677; PCT (PureCell Technologies Complex); PEG; PEG-liposomal prednisolone sodium phosphate; PF 06687234; PF-00547659; PF-00547659 SC Injection; PF-05230917; PF-05285401; PF-06480605; PF-06480605 100 mg/ml; PF-06651600; PF-06651600 10 mg; PF-06651600 50 mg; PF-06651600-15; PF-06687234; PF-06700841; PF-06700841 25 mg; PF-06700841 5 mg; PF-06700841-15; PF-06826647; PF-06826647 100 mg QD; PF-06826647 300 mg QD; PF-06826647 600 mg QD; PF-6826647 400 mg QD; PN-10884A; PN-943; PRD5973697; PREDNISOLONE; PREDNISOLONE SODIUM PHOSPHATE; PREDNISONE; PRIM-DJ2727; PRO145223; PRO145223 (RO5490261); PROPIONYL L-CARNITINE; PROPIONYL L-CARNITINE HYDROCHLORIDE; PRV-300; PS; PS-QD; PS-SP; PTG-100; PUR 0110; PUR 0110 Rectal Enema; PUR 0110 Rectal Enema 1000 mg; PUR 0110 Rectal Enema 250 mg; PUR 0110 Rectal Enema 500 mg; PV; Palmitoleic Acid; Palmitoleic acid; Parnaparin; Pending; Pentasa; Pentasa 2g sachet prolonged release granules (95%); Pentasa 500 mg Retardtabletten; Pentasa Compact 2g, granulate with prolonged release; Pentasa Compact 4g, granulate with prolonged release; Pentasa Sachet; Pentasa Sachet 1 g; Pentasa Sachet 1g; Pentasa Sachet 2 g; Pentasa enema; Pentasa prolonged release granules 2g; Pentasa sachet 1g; Pfefferminzblätter 1ml/10ml; Phosphate; Phosphatidylcholine; Photodynamic therapy with Gliolan; Picosulfate; Placebo; Polaprezinc; Polyethylene glycol; Polyphenon E®; Pomegranate; Prednisolon; Prednisolon Jenapharm; Prednisolone; Prednisolone Sodium Phosphate; Prednisolone Tablets B.P. 5mg; Prednisolone sodium metasulphobenzoate; Prednisone; Prefilled Syringe delivery of Golimumab; Previously referred to as MEDI2070 and AMG 139; Probiotic; Probiotic Formula Capsule; Probiotic Mixture; Probiotics; Procedure: Biopsies; Procedure: Blood sampling, endoscopy; Procedure: Colectomy; Procedure: Colonoscopy; Procedure: Colorectal biopsies; Procedure: Enema; Procedure: FMT; Procedure: Fecal microbiota transplantation; Procedure: Gastroscopy; Procedure: Hyperbaric oxygen; Procedure: Infusion of Saline; Procedure: Narrow Band Imaging; Procedure: Rectal dialysis; Procedure: Sham Hyperbaric Air; Procedure: Standardized FMT; Procedure: Stool samples; Procedure: colonoscopy; Procedure: lumbar puncture; Procedure: rectosigmoidoscopy; Procedure: sigmoidoscopy; Products containing aminosalicylate; Products containing azathioprine or 6-mercaptopurine; Proline; Promiten; Propionyl-L-Carnitine; Propionyl-L-carnitine; Propionylcarnitinhydrochlorid; Psyllium; Psyllium Husk Powder; Psyllium husk; Puri-Nethol; QBECO SSI; RAVAGALIMAB; RDP58; RECTABUL2mg rectal form; REMICADE; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; RIBOFLAVIN; RISANKIZUMAB; RO5490261 / F02; RO5490261/F02; RO5490261/F04-02; RO7049665; RO7246311; ROSUVASTATIN CALCIUM; RPC1063; RTNV148B IgG; Raspberry; Ravagalimab; Rebamipide; Recombinant Factor XIII (rFXIII); Rectal dialysis; Rectal tacrolimus; Regular treatment; Remestemcel-L; Remicade; Remicade (infliximab); Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten; Remicade 100 mg powder for concentrate for solution for infusion.; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima; Remsima (CT-P13); Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima and Inflectra; Retarded Release Phosphatidylcholine (rPC); Retarded release phosphatidylcholine; RhIL-11; RhuMAb Beta7; RhuMAb Beta7, Anti Beta 7, PRO145223; RhuMAb Beta7, Anti Beta7, PRO145223; RhuMab Beta7, Anti Beta7, PRO145223; Riboflavin; Rifaximin; Risankizumab; Risankizumab (Genetical Recombination); Risankizumab IV; Risankizumab SC; Rituximab; Rivenprost; Rivenprost (drug); Ro 549-0261/F04; Rosiglitazone; Rosuvastatin; Rosuvastatine EG; SANDINUM; SAR339658; SB-656933; SB-656933 Tablets; SB012; SB5; SC12267; SC12267 (4SC-101); SCH 900050; SER-287; SF257 C59; SHINGRIX; SHP647; SHR0302; SIMPONI; SODIUM HYALURONATE; SOYBEAN PHOSPHATIDYLCHOLINE; SPD476; SPD476 (mesalazine); SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine; SPESOLIMAB; SR140333B; SRT2104; ST 261; ST-0529; ST10-021; ST261; STELARA®; STNM01; STNM01 1.84 mg; STW5-II; STW5-II (Iberogast N, BAY98-7410); SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML; Salicylic acid; Saline; Salmon; Salofalk; Salofalk 1000mg Granu-Stix; Salofalk 1000mg Granu-Stix®; Salofalk 1000mg Granu-stix®; Salofalk 3g gastro-resistant prolonged-release granules; Salofalk 4g/60ml Klysma; Salofalk Granu-Stix 500 mg; Salofalk® 1000mg Granu-Stix®; Salofalk® 500 mg gastro-resistant tablet; Salofalk® 500 mg tablets; Salofalk® 500mg; Salofalk® 500mg Granu-Stix®; Sandimmum; Sandimmun; Sandimmun 50 mg/ml, infuusiokonsentraatti; Sandimmun Neoral; Semi-vegetarian diet; Serum bovine immunoglobulin; Shingrix; Simponi; Simponi (Golimumab); Simponi®; Simponi® (Golimumab); Simulect; Single dose-group A; Smartject Device delivery of Golimumab; Smoking cigarettes; Smoking of cannabis; Sodium Picosulfate/Magnesium Citrate Laxative; Solu-Medrol; Solu-medrol; Sotrastaurin; Sotrastaurin (INN) acetate; Soybean; Spesolimab; Spesolimab IV infusion; Spesolimab SC solution for injection; Standard 2 hours-infusion; Standard Therapy; Standardized FODMAP; Standardized anthocyanin-rich extract; Stasis; Stelara; Sterile saline for injection; Steroids; Sucrose; Sugar Extract; Sulphsalazine, Pentasa, Asacol, Colazide, Depentum; Suspension de microbiote fécal; Synergy-1; Synergy1; Sübetaholzwurzel 1ml/10ml; Süßholzwurzel 1ml/10ml; TA-650; TA-650 (Infliximab); TD-1473; TD-1473 Dose A; TD-1473 Dose B; TD-1473 Dose C; TD-3504; THRX-139060; TJ301 300mg; TJ301 600mg; TOFACITINIB; TOP1288; TOP1288 Rectal solution; TOP1288 rectal solution; TP05; TP05 Coating A; TP05 Coating B; TP05 Coating D; TP05 Coating E; TP05 Coating H; TREMFYA®; TSO; Tacrolimus; Tauroursoursodeoxycholic acid, brand name Tudcabil; Telotristat; Telotristat Etiprate; Telotristat etiprate; Terbinafine; Tetomilast; Tetracycline; Thalidomide; Thalidomide Pharmion; Threonine; To be confirmed; To be requested; Tofacitinib; Tofacitinib citrate; Tofacitinib citrate (Phase III Formulation); Tofacitinib citrate (Proposed commercial formulation - debossed); Tofacitinib citrate (Proposed commercial formulation – debossed); Tofacitinib citrate (Proposed commercialFormulation - debossed); Tofacitinib citrate (clinical trial image); Traditional treatments; Tralokinumab; Treatment Algorithm A; Treatment Algorithm B; Treatment Algorithm C; Tremfya; Trexan; Trexan inj 25 mg/ml; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (TSO); Tris; UCB4940; UCMSC group; UDCA; UR-12746-S; USTEKINUMAB; UTTR1147A; UTTR1147A, IL22-Fc, IL-22Fc; UTTR1147A/RO7021610 (Active); Umbilical Cord Mesenchymal Stem Cells; Unknown; Upadacitinib; Upadacitinib (ABT-494); Upadacitinib - Direct compression-yellow; Upadacitinib - Wet Granulation-Yellow; Upadacitinib -Direct compression-yellow; Updacitinib (ABT-494); Urbason; Ursodeoxycholic acid; Ursodiol; Ursodiol (ursodeoxycholic acid, UDCA); Ursofalk; Ustekinumab; Ustekinumab Dose Based on BSA and Body Weight; Ustekinumab IV; Ustekinumab IV Infusion; Ustekinumab SC; Ustekinumab SC Injection; Usual current care; V565; VB-201; VB-201 160mg; VEDOLIZUMAB; VSL#3; VSL#3 (Original De Simone formulation); VSL#3®; Vaccine Vivotif + Vaccine Dukoral; Vaccine Vivotif + Vaccine Dukoral + oats; Valganciclovir; Vaminolac; Vaminolac, komb.; Vamorolone; Vamorolone 4% suspension for oral dosing; Vancomycin; Vancomycin Pre-Treat; Vancomycin Pre-Treatment; Vatelizumab; Vedolizumab; Vedolizumab 108 mg SC; Vedolizumab 300 mg; Vedolizumab 300 mg IV; Vedolizumab IV; Vedolizumab IV, Placebo IV, Placebo SC; Vedolizumab IV, Placebo SC; Vedolizumab Injection; Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV; Vedolizumab SC; Vedolizumab SC 108 mg; Vedolizumab intravenous injection; Vedolizumab subcutaneous injection; Vidofludimus; Vidofludimus calcium; Vidofludimus calcium dihydrate; Vigantol; Vigantol Oel; Vigantol Oel TM; Visilizumab; Visilizumab (HuM291; Visilizumab (Nuvion); Visilizumab (Nuvion®; Vitamin B2; Vitamin D; Vitamin D drops; Vitamin D3; Vitamin E; Vitamin E 800IU; Vitamin K; Vitamin K 10 mg; Vivotif; Warfarin; Warfarin 10 mg; Water; Wharton Jelly Mesenchymal stem cells; XELJANZ; Xeljanz; Xeljanz 5 mg film-coated tablets; Xeljanz 5mg film-coated tablets; Z-206; Zessly; Zoenasa-1:4; [124I]IB PF 06687234; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F]FSPG; [BI 655130]; [CC-10004]; [N/A]

No.	TrialID	Date_ enrollment	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	EUCTR2018-001546-33-GB (EUCTR)	11/07/2018	14/05/2018	The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease	IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0	Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab	University Southampton Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
2	JPRN-UMIN000027465	2017/05/29	24/05/2017	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients	ulcerative colitis	Infliximab (5mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)	University of Toyama	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not selected	Japan
3	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
4	NCT02148640 (ClinicalTrials.gov)	October 2014	23/5/2014	The NOR-SWITCH Study	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY	Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic	Drug: Innovator infliximab;Drug: Biosimilar infliximab	Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority	Completed	18 Years	N/A	All	482	Phase 4	Norway
5	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-001546-33-GB
(EUCTR)

11/07/2018

14/05/2018

The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease

IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0

Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

University Southampton Hospital NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

JPRN-UMIN000027465

2017/05/29

24/05/2017

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients

ulcerative colitis

Infliximab (5mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)

University of Toyama

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)

Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

NCT02148640
(ClinicalTrials.gov)

October 2014

23/5/2014

The NOR-SWITCH Study

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY

Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic

Drug: Innovator infliximab;Drug: Biosimilar infliximab

Diakonhjemmet Hospital

South-Eastern Norway Regional Health Authority

Completed

18 Years

N/A

All

482

Phase 4

Norway

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway