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

  
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004435-72-IT
(EUCTR)
27/02/201529/09/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - Cottonwood 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]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ND
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2568Phase 3Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
2EUCTR2008-002784-14-IT
(EUCTR)
22/07/200917/03/2009A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - NDA Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD)
MedDRA version: 9.1;Level: LLT;Classification code 10045282
MedDRA version: 9.1;Level: PT;Classification code 10011401
Product Name: Vedolizumab
Product Code: MLN0002
MILLENNIUM PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
1508Phase 3Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
3EUCTR2008-002782-32-IT
(EUCTR)
22/07/200922/01/2009A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - NDA Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND Patients with Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
MILLENNIUM PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
4EUCTR2008-003913-28-IT
(EUCTR)
25/05/200916/04/2009Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - NDRandomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND Mild to moderate ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide
COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: yes
Male: yes
150Italy
5EUCTR2008-004564-40-IT
(EUCTR)
23/01/200929/09/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - NDA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC
Product Name: CP-690,550
Product Name: CP-690,550
Product Name: CP-690,550
PFIZERNULLNot RecruitingFemale: yes
Male: yes
200Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
6EUCTR2007-004157-28-IT
(EUCTR)
17/06/200801/10/2008A 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 Colitis - NDA 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 - ND Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
INN or Proposed INN: AdalimumabAbbott GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
7EUCTR2007-007702-30-IT
(EUCTR)
03/04/200808/07/2008Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - NDFeasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND Ulcerative colitis
MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: no
Male: yes
Italy
8EUCTR2006-006052-35-IT
(EUCTR)
08/08/200715/05/2007An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - NDAn open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: NicolonS.L.A. PHARMA (UK) LTDNULLNot RecruitingFemale: yes
Male: yes
Italy
9EUCTR2006-002781-20-IT
(EUCTR)
17/04/200707/03/2007A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - NDA multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: HUMIRAAbbott GmbH Co. KGNULLNot RecruitingFemale: yes
Male: yes
250Hungary;Germany;Czech Republic;Italy;Austria;Sweden
10EUCTR2006-001782-42-IT
(EUCTR)
03/11/200620/12/2006Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - NDEfficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: CB-01-05-MMXCOSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: yes
Male: yes
120Hungary;United Kingdom;Italy
11EUCTR2005-003481-42-IT
(EUCTR)
08/06/200611/07/2007A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - NDA Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND subjects with IVSR-UC
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: visilizumab
INN or Proposed INN: visilizumab
PDL BioPharma, Inc;NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece