100 mg    (DrugBank: -)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎17

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.
17 / 2,269 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
1EUCTR2020-004391-18-FR
(EUCTR)
28/10/202014/09/2020IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITISIMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Inflectra 100 mg
Product Name: Inflectra 100 mg
Trade Name: AMGEVITA
Product Name: AMGEVITA
Trade Name: Simponi
Product Name: Simponi
Trade Name: Entyvio 300 mg
Product Name: Entyvio 300 mg
Trade Name: XELJANZ
Product Name: XELJANZ
CHU Amiens-PicardieNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4France
2NCT04209556
(ClinicalTrials.gov)
June 30, 20201/12/2019A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative ColitisA PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITISUlcerative ColitisDrug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QDPfizerNULLRecruiting18 Years75 YearsAll202Phase 2United States
3EUCTR2019-002698-74-SK
(EUCTR)
26/03/202031/01/2020A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitisA PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2 A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PF-06480605 100 mg/ml
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A
Pfizer IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;India;France;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Japan;China
4NCT03884439
(ClinicalTrials.gov)
March 18, 20194/3/2019Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)Crohn's Disease;Ulcerative ColitisDrug: Infliximab [infliximab biosimilar 3]PfizerNULLRecruitingN/AN/AAll300Japan
5NCT03669029
(ClinicalTrials.gov)
October 1, 20184/7/2018Optimization of Golimumab Treatment in Ulcerative ColitisOptimization of Golimumab Treatment in Ulcerative ColitisColitis, UlcerativeDrug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization.Hospital de ManisesValencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp.Unknown status18 Years80 YearsAll50Phase 4Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03358706
(ClinicalTrials.gov)
February 2, 201827/11/2017A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative ColitisA Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.Crohn Disease;Ulcerative ColitisDrug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mgJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll57Phase 1United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark
7EUCTR2016-002061-54-IT
(EUCTR)
13/10/201615/11/2018Switch 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. GEMELLINULLNot RecruitingFemale: yes
Male: yes
250Phase 4Italy
8EUCTR2015-001954-14-NL
(EUCTR)
14/09/201525/08/2015Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research ulcerative colitis and Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion
Product Name: Inflectra 100 mg powder for concentrate for solution for infusion
Trade Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Code: EMEA/H/C/000240
SanteonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
9EUCTR2014-002056-40-NO
(EUCTR)
12/08/201413/06/2014A 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 psoriasisA 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 ASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway
10EUCTR2011-002462-20-SK
(EUCTR)
19/11/201227/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
Hungary;Czech Republic;Slovakia;Poland;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-002462-20-PL
(EUCTR)
27/12/201120/10/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Czech Republic;Poland;Germany;Italy
12EUCTR2011-002462-20-HU
(EUCTR)
07/12/201122/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
Czech Republic;Hungary;Poland;Germany;Italy
13EUCTR2011-002462-20-CZ
(EUCTR)
24/11/201120/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
Hungary;Czech Republic;Poland;Germany;Italy
14EUCTR2011-002462-20-DE
(EUCTR)
25/10/201113/09/2011Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisRandomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Dr August Wolff GmbH & Co KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Czech Republic;Poland;Germany;Italy
15EUCTR2006-005299-42-FI
(EUCTR)
25/02/200827/12/2007A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDYA randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti
INN or Proposed INN: CICLOSPORIN
Trade Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten
INN or Proposed INN: INFLIXIMAB
Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)NULLNot RecruitingFemale: yes
Male: yes
100France;Finland;Belgium;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT00488631
(ClinicalTrials.gov)
September 200718/6/2007An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeBiological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mgJanssen Research & Development, LLCMerck Sharp & Dohme Corp.Completed18 YearsN/AAll1228Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom
17NCT00487539
(ClinicalTrials.gov)
August 200714/6/2007An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeBiological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mgJanssen Research & Development, LLCMerck Sharp & Dohme Corp.Completed18 YearsN/AAll1065Phase 2;Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom