49. 全身性エリテマトーデス [臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191

Searched query = "Systemic lupus erythematosus", "SLE"
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"
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-004575-37-GB
(EUCTR)
14/03/200808/10/2008A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
460Phase 2;Phase 3France;Belgium;United Kingdom
2EUCTR2005-004575-37-BE
(EUCTR)
21/11/200715/06/2007A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
460Phase 2;Phase 3France;Belgium;United Kingdom
3EUCTR2005-004575-37-FR
(EUCTR)
27/04/200726/03/2007A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07). IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 2/3United Kingdom;Belgium;France
4EUCTR2004-004051-19-AT
(EUCTR)
30/08/200526/07/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Austria;Germany;Italy;United Kingdom;Sweden
5EUCTR2004-004051-19-BE
(EUCTR)
29/08/200529/06/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Austria;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2004-004051-19-SE
(EUCTR)
01/06/200529/03/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific.A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific. SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Germany;Italy;Sweden
7EUCTR2004-004051-19-DE
(EUCTR)
13/05/200522/03/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United Kingdom;Germany;Italy;Sweden
8EUCTR2004-004051-19-GB
(EUCTR)
18/04/200524/03/2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 dated 03-June-2005 + Amendment 1 dated 08-Feb-2005A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 dated 03-June-2005 + Amendment 1 dated 08-Feb-2005 SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Germany;United Kingdom;Italy;Sweden