97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


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

  
31 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-001682-16-DK
(EUCTR)
09/05/201913/05/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
2EUCTR2015-001346-29-CZ
(EUCTR)
13/11/201703/06/2016A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
93Phase 3United States;Slovakia;Spain;Austria;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden
3EUCTR2015-001346-29-BE
(EUCTR)
22/08/201622/09/2015 A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
93 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden
4EUCTR2015-001346-29-ES
(EUCTR)
31/03/201630/10/2015A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
93 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden
5EUCTR2015-001346-29-GB
(EUCTR)
08/02/201628/09/2015A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
93Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden
6EUCTR2015-001346-29-HU
(EUCTR)
02/02/201628/09/2015A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
93Phase 3United States;Hungary;Canada;Spain;Australia;Israel;United Kingdom;New Zealand
7EUCTR2015-001346-29-SK
(EUCTR)
12/11/201530/10/2015A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 20 mg solution for injection in pre-filled syringe (20 mg/0.2mL)
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe (40 mg/0.4 mL)
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 80 mg solution for injection in pre-filled syringe (80 mg/0.8 mL)
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
59Phase 3United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Poland;Japan;New Zealand;Sweden
8EUCTR2013-003032-77-PL
(EUCTR)
05/11/201528/08/2014A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
93Phase 3United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand
9EUCTR2013-001682-16-BE
(EUCTR)
15/01/201522/04/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Canada;Poland;Spain;Belgium;Israel;Netherlands;Germany;Italy;Japan;Switzerland
10EUCTR2013-001682-16-PL
(EUCTR)
08/12/201422/09/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
840Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
11EUCTR2013-003032-77-HU
(EUCTR)
04/12/201430/12/2013A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Hungary;United States;United Kingdom;Spain;New Zealand;Canada;Austria;Czech Republic;Belgium;Poland;Italy;Israel;Slovakia;Australia;France
12EUCTR2013-001682-16-NL
(EUCTR)
28/11/201401/05/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
840Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan
13EUCTR2013-003032-77-CZ
(EUCTR)
06/11/201431/07/2014A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
93Phase 3United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand
14EUCTR2013-003032-77-GB
(EUCTR)
30/10/201419/12/2013A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
85Phase 3United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand
15EUCTR2013-001682-16-DE
(EUCTR)
22/09/201410/04/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
840Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
16EUCTR2013-003032-77-IT
(EUCTR)
10/09/201419/12/2013A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 3United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
17EUCTR2013-001682-16-IT
(EUCTR)
02/09/201423/04/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
18EUCTR2013-003032-77-BE
(EUCTR)
25/08/201402/01/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Belgium;Poland;Italy;Israel;Slovakia;Australia;France
19EUCTR2013-001682-16-CZ
(EUCTR)
21/08/201418/06/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
840Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
20EUCTR2013-001682-16-ES
(EUCTR)
25/07/201408/05/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
525 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
21EUCTR2013-001682-16-AT
(EUCTR)
03/07/201416/06/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
840Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
22EUCTR2013-001682-16-HU
(EUCTR)
18/06/201422/04/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
23EUCTR2013-001682-16-SK
(EUCTR)
10/06/201429/04/2014A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative ColitisA Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis 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: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
840Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
24EUCTR2013-003032-77-ES
(EUCTR)
25/03/201427/02/2014 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
25EUCTR2013-003032-77-SK
(EUCTR)
13/03/201423/01/2014 A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
93 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand
26EUCTR2013-003032-77-AT
(EUCTR)
29/01/201408/01/2014A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
93Phase 3Hungary;United States;United Kingdom;Spain;New Zealand;Canada;Austria;Czech Republic;Belgium;Poland;Italy;Israel;Slovakia;France
27EUCTR2013-003032-77-FR
(EUCTR)
19/06/2015 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
28EUCTR2015-001346-29-SE
(EUCTR)
30/09/2015A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
93Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;United Kingdom;New Zealand;Japan;Sweden
29EUCTR2015-001346-29-PL
(EUCTR)
21/03/2016A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 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: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 20 mg solution for injection in pre-filled syringe (20 mg/0.2mL)
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe (40 mg/0.4 mL)
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 80 mg solution for injection in pre-filled syringe (80 mg/0.8 mL)
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
59Phase 3United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden
30EUCTR2014-004559-29-Outside-EU/EEA
(EUCTR)
12/11/2014A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative ColitisA Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Inc.NULLNAFemale: yes
Male: yes
274Japan
31EUCTR2015-001346-29-AT
(EUCTR)
12/01/2016A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
93Phase 3United States;Spain;Austria;Israel;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Japan;New Zealand;Sweden