Amgevita ( 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	9

96. クローン病

臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209

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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	EUCTR2020-001811-26-BE (EUCTR)	18/11/2021	22/07/2021	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprot ...	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: INFLIXIMA ...	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Phase 4	Belgium;Netherlands
2	EUCTR2020-001811-26-NL (EUCTR)	30/09/2020	08/07/2020	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprot ...	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: INFLIXIMA ...	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Netherlands
3	EUCTR2019-003662-40-DE (EUCTR)	18/12/2019	22/10/2019	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and ...	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and ...	MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System ...	Trade Name: Amgevita40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trad ...	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	82	Phase 4	Germany
4	NCT04131322 (ClinicalTrials.gov)	October 10, 2019	10/10/2019	Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.	Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: ...	Crohn Disease;Ulcerative Colitis	Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	NULL	Terminated	18 Years	N/A	All	24	Phase 4	Spain
5	EUCTR2019-000717-37-ES (EUCTR)	27/06/2019	28/06/2019	Loss of response of the Adalimumba biosimilar compared with the original drug	LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB O ...	Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - ...	Trade Name: AMGEVITA® Product Name: AMGEVITA(Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: ...	Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Spain

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97. 潰瘍性大腸炎

臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

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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	EUCTR2020-001811-26-BE (EUCTR)	18/11/2021	22/07/2021	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprot ...	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: INFLIXIMA ...	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Phase 4	Belgium;Netherlands
2	EUCTR2020-003420-16-ES (EUCTR)	11/08/2021	23/06/2021	A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcera ...	SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MOD ...	Moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;T ...	Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Other descriptive name: Amgevita	Instituto Clinico Humanitas	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 4	Portugal;France;Belgium;Spain;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
3	EUCTR2020-003420-16-BE (EUCTR)	16/07/2021	30/06/2021	A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcera ...	SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MOD ...	Moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;T ...	Trade Name: Amgevita INN or Proposed INN: Adalimumab 40mg Trade Name: Azathioprine Other descriptive na ...	Instituto Clinico Humanitas	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 4	Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
4	EUCTR2020-003420-16-IT (EUCTR)	29/01/2021	02/08/2021	A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcera ...	SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MOD ...	Moderate to severe ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365; ...	Trade Name: Amgevita Product Name: Adalimumab Product Code: [n.d.] INN or Proposed INN: ADALIMUMAB Produ ...	IRCCS ISTITUTO CLINICO HUMANITAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Phase 4	Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
5	EUCTR2020-004391-18-FR (EUCTR)	28/10/2020	14/09/2020	IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS ...	IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS ...	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 ...	CHU Amiens-Picardie	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	France
6	EUCTR2020-001811-26-NL (EUCTR)	30/09/2020	08/07/2020	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprot ...	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: INFLIXIMA ...	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Netherlands
7	EUCTR2019-003662-40-DE (EUCTR)	18/12/2019	22/10/2019	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and ...	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and ...	MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System ...	Trade Name: Amgevita40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trad ...	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	82	Phase 4	Germany
8	NCT04131322 (ClinicalTrials.gov)	October 10, 2019	10/10/2019	Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.	Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: ...	Crohn Disease;Ulcerative Colitis	Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	NULL	Terminated	18 Years	N/A	All	24	Phase 4	Spain
9	EUCTR2019-000717-37-ES (EUCTR)	27/06/2019	28/06/2019	Loss of response of the Adalimumba biosimilar compared with the original drug	LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB O ...	Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - ...	Trade Name: AMGEVITA® Product Name: AMGEVITA(Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: ...	Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Spain

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