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"
35 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-003707-37-BE25/05/200718/12/2006A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Belgium;Austria
2EUCTR2005-003707-37-AT09/05/200703/01/2007A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Belgium;Austria
3EUCTR2005-004105-28-FR26/04/200723/02/2007An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ SAn Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece
4EUCTR2005-004105-28-GR15/03/200715/02/2007An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ SAn Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece
5EUCTR2005-003482-17-GB26/02/200701/02/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2United Kingdom;Spain;Ireland;Italy;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2005-003481-42-GR30/01/200724/11/2006A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
7EUCTR2005-003482-17-GR30/01/200724/11/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ DA Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United Kingdom;Spain;Ireland;Italy;Greece
8NCT00502294January 200713/7/2007A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative ColitisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative ColitisIntravenous Steroid-Refractory Ulcerative ColitisDrug: Visilizumab (HuM291; Nuvion®)Facet BiotechPDL BioPharma, Inc.Withdrawn18 YearsN/ABoth150Phase 3NULL
9EUCTR2005-004105-28-DE11/10/200610/04/2006An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ SAn Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Hungary;United Kingdom;Germany;Netherlands;France;Ireland;Greece
10EUCTR2005-004105-28-NL28/09/200610/08/2006An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative ColitisAn Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody
PDL BioPharma, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT00355901September 200621/7/2006An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative ColitisAn Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative ColitisUlcerative ColitisDrug: Visilizumab (Nuvion®; HuM291)PDL BioPharma, Inc.NULLTerminated18 YearsN/ABoth300United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Ukraine
12NCT00279435August 200617/1/2006Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyUlcerative ColitisDrug: visilizumabFacet BiotechPDL BioPharma, Inc.Terminated18 YearsN/ABoth25Phase 2/Phase 3United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Ukraine
13EUCTR2005-004105-28-GB20/06/200607/03/2006An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC).
MedDRA version: 8.0Level: LLTClassification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece
14EUCTR2005-004105-28-IE20/06/200610/02/2006An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC).
MedDRA version: 8.0Level: LLTClassification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;Hungary;Greece;Ireland;Netherlands;Germany;United Kingdom
15EUCTR2005-003481-42-IT08/06/200611/07/2007A 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: 9.1Level: LLTClassification code 10009900Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2005-003482-17-IT08/06/200604/12/2006A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis.A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis. Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis
MedDRA version: 6.1Level: PTClassification code 10009900
Product Name: visilizumab
Product Code: HuM291
Product Name: visilizumab
Product Code: HuM291
Product Name: visilizumab
Product Code: HuM291
PDL BioPharma , Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United Kingdom;Spain;Ireland;Italy;Greece
17EUCTR2005-003481-42-ES26/05/200615/03/2006A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos
MedDRA version: 8.0Level: LLTClassification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece
18EUCTR2005-003482-17-ES26/05/200615/03/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos.A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 8.0Level: LLTClassification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United Kingdom;Ireland;Spain;Italy;Greece
19EUCTR2005-003481-42-SK21/04/200625/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
20EUCTR2005-002063-87-HU04/04/200602/05/2007A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Germany;Czech Republic;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2005-003481-42-HU04/04/200628/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
22EUCTR2005-003481-42-IE04/04/200610/01/2006A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
23NCT00307827April 200624/3/2006Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative ColitisUlcerative ColitisDrug: VisilizumabAbbottNULLTerminated18 YearsN/ABoth38Phase 2United States;Canada;Croatia;Italy;Russian Federation;Spain;Ireland;Poland;Serbia;Switzerland
24EUCTR2005-003481-42-DE22/03/200629/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece
25EUCTR2005-002063-87-DE22/03/200629/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Czech Republic;Germany;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2005-002063-87-SK16/03/200623/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany
27EUCTR2005-003482-17-IE03/03/200610/01/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 8.0Level: LLTClassification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2Greece;Spain;Ireland;Italy;United Kingdom
28EUCTR2005-003481-42-CZ16/02/200628/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0Level: LLTClassification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece
29EUCTR2005-002063-87-CZ16/02/200628/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2/3Hungary;Germany;Czech Republic;Belgium
30EUCTR2005-002063-87-BE09/02/200624/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Germany;Czech Republic;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00279422February 200617/1/2006A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative ColitisUlcerative ColitisDrug: visilizumabFacet BiotechPDL BioPharma, Inc.Terminated18 YearsN/ABoth127Phase 2/Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;Norway;Slovakia;Ukraine
32EUCTR2005-003481-42-AT04/01/200630/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, IncNULLNot RecruitingFemale: yes
Male: yes
80Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
33EUCTR2005-002063-87-AT28/12/200523/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Czech Republic;Belgium;Austria;Germany
34NCT00267306January 200416/12/2005Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative ColitisA Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous CorticosteroidsSevere Ulcerative ColitisDrug: VisilizumabFacet BiotechPDL BioPharma, Inc.Completed16 Years70 YearsBoth144Phase 1/Phase 2United States
35NCT00032305March 200214/3/2002Research Study in Patients With Severe Ulcerative ColitisA Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to CorticosteroidsUlcerative ColitisDrug: VisilizumabFacet BiotechNULLCompleted18 Years70 YearsBoth20Phase 2/Phase 3United States