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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
25 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-002411-29-PL
(EUCTR)
19/12/201317/10/2013A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
2EUCTR2011-002411-29-CZ
(EUCTR)
15/11/201316/09/2013A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
3EUCTR2011-002411-29-SK
(EUCTR)
11/11/201314/10/2013A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
4EUCTR2011-002411-29-ES
(EUCTR)
10/08/201218/10/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
680Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
5EUCTR2011-002411-29-FI
(EUCTR)
29/06/201211/06/2012A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
680Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-002411-29-AT
(EUCTR)
26/06/201201/02/2012A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
7EUCTR2011-002411-29-PT
(EUCTR)
01/06/201203/01/2012A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
680Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
8EUCTR2011-002411-29-DE
(EUCTR)
11/05/201211/11/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
9EUCTR2011-002411-29-GB
(EUCTR)
03/05/201207/11/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Abbvie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
10EUCTR2011-002411-29-SE
(EUCTR)
26/04/201213/10/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-002411-29-DK
(EUCTR)
30/03/201228/11/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
12EUCTR2011-002411-29-IE
(EUCTR)
30/03/201209/02/2012A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
13EUCTR2011-002411-29-BE
(EUCTR)
07/03/201223/11/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
455Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
14EUCTR2011-002411-29-IT
(EUCTR)
20/02/201207/03/2012A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
ABBOTT GMBH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
680Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden
15EUCTR2011-002411-29-GR
(EUCTR)
09/01/201207/12/2011A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A Ulcerative Colitis
MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
680Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-004268-31-DK
(EUCTR)
13/12/201121/11/2011Adalimumab (Humira) in the treatment of chronic pouchitisAdalimumab (Humira) in the treatment of chronic pouchitis Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis
MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringes
Product Name: Humira
Product Code: EMEA/H/C/000481
Odense University HospitalNULLNot RecruitingFemale: yes
Male: yes
24Denmark
17EUCTR2007-004157-28-SE
(EUCTR)
22/10/200906/05/2009Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden
18EUCTR2007-004157-28-PT
(EUCTR)
17/03/200912/12/2008A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative ColitisA Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
19EUCTR2007-004157-28-NL
(EUCTR)
09/12/200810/12/2008Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
20EUCTR2007-004157-28-DE
(EUCTR)
07/08/200825/03/2008Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2007-004157-28-SK
(EUCTR)
04/08/200809/04/2008A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative ColitisA Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
22EUCTR2007-004157-28-HU
(EUCTR)
09/07/200828/03/2008Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia
23EUCTR2007-004157-28-BE
(EUCTR)
23/06/200813/12/2007Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Germany;Norway;New Zealand;Sweden;Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands
24EUCTR2007-004157-28-CZ
(EUCTR)
09/06/200810/04/2008Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
25EUCTR2007-004157-28-AT
(EUCTR)
30/04/200808/04/2008Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
592Phase 3Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden