Flixabi ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病5
97潰瘍性大腸炎5

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001811-26-BE
(EUCTR)
18/11/202122/07/2021IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Belgium;Netherlands
2EUCTR2020-001811-26-NL
(EUCTR)
30/09/202008/07/2020IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Netherlands
3EUCTR2018-001546-33-GB
(EUCTR)
11/07/201814/05/2018The 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 diseaseIBD 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 TrustNULLNot RecruitingFemale: yes
Male: yes
200Phase 4United Kingdom
4NCT03662919
(ClinicalTrials.gov)
July 2, 20186/9/2018One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort StudyPERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort StudyArthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, UlcerativeDrug: Infliximab;Drug: AdalimumabBiogenNULLActive, not recruiting6 YearsN/AAll2274France
5NCT03108326
(ClinicalTrials.gov)
April 15, 201730/3/2017Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s DiseaseReal World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term OutcomeCrohn DiseaseBiological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraCed Service GmbHNULLRecruiting18 Years80 YearsAll900Germany

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001811-26-BE
(EUCTR)
18/11/202122/07/2021IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Belgium;Netherlands
2EUCTR2020-001811-26-NL
(EUCTR)
30/09/202008/07/2020IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Netherlands
3EUCTR2018-003524-36-IE
(EUCTR)
25/03/202005/11/2019Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: NA
Product Code: NA
INN or Proposed INN: INFLIXIMAB
Trade Name: Metoject
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
UMC Amsterdam location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 4Ireland;Netherlands
4EUCTR2018-002673-21-FR
(EUCTR)
04/09/201806/07/2018EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Centre Hospitalier Universitaire de RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4France
5EUCTR2018-001546-33-GB
(EUCTR)
11/07/201814/05/2018The 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 diseaseIBD 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 TrustNULLNot RecruitingFemale: yes
Male: yes
200Phase 4United Kingdom