Cellcept    (DrugBank: -)

5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症9
13多発性硬化症/視神経脊髄炎3
42結節性多発動脈炎5
43顕微鏡的多発血管炎3
49全身性エリテマトーデス4

11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118
Searched query = "Myasthenia", "MG"
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.
9 / 226 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-000343-28-IT
(EUCTR)
29/03/200615/03/2006An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - NDAn optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND Myasthenia Gravis
MedDRA version: 6.1;Level: PT;Classification code 10028417
Trade Name: cellcept
INN or Proposed INN: Mycophenolic acid
ASPREVA PHARMACEUTICALS CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
136United Kingdom;Germany;Spain;Italy
2EUCTR2005-000343-28-DE
(EUCTR)
19/12/200510/05/2005An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) Myasthenia Gravis
MedDRA version: 8.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis
Trade Name: Cellcept 500 mg tablets
Product Name: CellCept 500 mg tablets
INN or Proposed INN: mycophenolate mofetil
Aspreva Pharmaceuticals CorporationNULLNot RecruitingFemale: yes
Male: yes
136Spain;Germany;Italy;United Kingdom
3EUCTR2004-000596-34-HU
(EUCTR)
30/09/200508/06/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. Myasthenia gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Trade Name: CellCept®500 mg tablets
Product Name: CellCept 500 mg film-coated tablets
INN or Proposed INN: mycophenolate mofetil
F. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease ProgramNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
4EUCTR2005-000343-28-GB
(EUCTR)
05/09/200528/06/2005An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) Myasthenia Gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Product Name: CellCept 500 mg tablets
INN or Proposed INN: mycophenolate mofetil
Aspreva Pharmaceutical CorporationNULLNot RecruitingFemale: yes
Male: yes
136Germany;United Kingdom;Spain;Italy
5EUCTR2004-000596-34-ES
(EUCTR)
01/09/200505/07/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. Myasthenia gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Trade Name: CellCept®500 mg tablets
Product Name: CellCept 500 mg film-coated tablets
INN or Proposed INN: mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2004-000596-34-IT
(EUCTR)
01/06/200520/06/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG)A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) Myastenia gravis
MedDRA version: 6.1;Level: PT;Classification code 10028417
Trade Name: CELLCEPT
INN or Proposed INN: Mycophenolic acid
ASPREVA PHARMACEUTICALS CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
7EUCTR2004-000596-34-CZ
(EUCTR)
19/05/200506/05/2005A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravisA prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis Myasthenia gravis
MedDRA version: 7.1;Level: LLT;Classification code 10028417
Trade Name: CellCept 500 mg
Product Name: CellCept
F.Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
8NCT00683969
(ClinicalTrials.gov)
August 200419/5/2008A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia GravisA Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: mycophenolate mofetil (CellCept);Drug: placeboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years80 YearsBoth136Phase 3United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;United Kingdom
9NCT00408213
(ClinicalTrials.gov)
June 20045/12/2006A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of PrednisoneMyasthenia Gravis GeneralisedDrug: mycophenolate mofetil [CellCept];Drug: PlaceboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years80 YearsBoth136Phase 3United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands

13. 多発性硬化症/視神経脊髄炎 [臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228
Searched query = "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
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.
3 / 3,050 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00618527
(ClinicalTrials.gov)
August 20066/2/2008Combination Therapy Using Cellcept and Rebif in RRMSCombination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple SclerosisMultiple SclerosisDrug: mycophenolate mofetil (Cellcept);Drug: human interferon beta 1a (Rebif)Aaron BosterEMD Serono;PfizerCompleted18 Years65 YearsBoth31Phase 0United States
2NCT00324506
(ClinicalTrials.gov)
May 20069/5/2006Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple SclerosisA Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: Mycophenolate Mofetil (CellCept)University of Texas Southwestern Medical CenterAspreva PharmaceuticalsCompleted18 Years55 YearsBoth43Phase 2United States
3NCT00223301
(ClinicalTrials.gov)
July 200419/9/2005Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple SclerosisA One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple SclerosisMultiple SclerosisDrug: Mycophenolate Mofetil (cellcept)University of Texas Southwestern Medical CenterRoche Pharma AG;Biogen IdecCompleted21 Years45 YearsBoth24Phase 2/Phase 3United States

42. 結節性多発動脈炎 [臨床試験数:14,薬物数:27(DrugBank:16),標的遺伝子数:26,標的パスウェイ数:102
Searched query = "Polyarteritis nodosa", "PAN"
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.
5 / 14 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004668-71-ES
(EUCTR)
13/10/201605/08/2016A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 19.0;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden
2EUCTR2013-004668-71-IT
(EUCTR)
01/08/201614/07/2015A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 19.0;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;Italy;United Kingdom;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden
3EUCTR2013-004668-71-GB
(EUCTR)
25/09/201425/09/2014A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 17.0;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
University College LondonNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Croatia;Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Germany;Netherlands;Sweden
4EUCTR2013-004668-71-BE
(EUCTR)
12/04/2017A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 19.1;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
INN or Proposed INN: CYCLOPHOSPHAMIDE
University College LondonNULLNAFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden
5EUCTR2013-004668-71-PT
(EUCTR)
16/02/2016A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 18.1;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
University College LondonNULLNAFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Poland;Belgium;Croatia;Germany;Netherlands;Sweden

43. 顕微鏡的多発血管炎 [臨床試験数:85,薬物数:80(DrugBank:19),標的遺伝子数:13,標的パスウェイ数:85
Searched query = "Microscopic polyangiitis", "MPA"
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.
3 / 85 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-001663-33-IT
(EUCTR)
09/06/200828/05/2008A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYCA randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC ANCA-associated vasculitis (Microscopic Polyangiitis, Wegener's granulomatosis)
MedDRA version: 9.1;Level: HLT;Classification code 10047113;Term: Vasculitides NEC
Trade Name: CELLCEPT
INN or Proposed INN: Mycophenolic acid
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Vasculitis and Lupus ClinicNULLNot RecruitingFemale: yes
Male: yes
140France;Spain;Austria;Germany;United Kingdom;Italy;Sweden
2EUCTR2006-001663-33-SE
(EUCTR)
13/05/200819/03/2008A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYCA randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC Anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Wegener´s granulomatosis (WG) and microscopic polyangiitis (MPA) are primary systemic vasculitides associated with ANCATrade Name: Cellcept
Product Name: Cellcept
Product Code: Ro106-1443
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Sendoxan
Product Name: Sendoxan
Product Code: 5009111000001105
INN or Proposed INN: CYCLOPHOSPHAMIDE
Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Germany;United Kingdom;France;Spain;Italy;Austria;Sweden
3NCT00405860
(ClinicalTrials.gov)
December 200229/11/2006CellCept in p-ANCA VasculitisA Pilot Study of Mycophenolate Mofetil (MMF) in Patients With p-ANCA Microscopic Polyangiitis and Mild to Moderate Renal Dysfunction.MPO-ANCA Vasculitis;Microscopic PolyangiitisDrug: CellCept (mycophenolate mofetil)Mayo ClinicRoche Pharma AGCompleted18 YearsN/ABoth18Phase 1United States

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.
4 / 827 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
4NCT00594932
(ClinicalTrials.gov)
November 20064/1/2008Biomarker-Linked Outcomes of Cellcept in Lupus ArthritisBiomarker-Linked Outcomes of Cellcept in Lupus ArthritisSystemic Lupus Erythematosus;ArthritisDrug: mycophenolate mofetil;Other: placeboOklahoma Medical Research FoundationNYU Langone HealthCompleted14 Years70 YearsAll27Phase 1/Phase 2United States