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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2005-000343-28-IT (EUCTR) | 29/03/2006 | 15/03/2006 | 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 - ND | 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 - ND | Myasthenia Gravis MedDRA version: 6.1;Level: PT;Classification code 10028417 | Trade Name: cellcept INN or Proposed INN: Mycophenolic acid | ASPREVA PHARMACEUTICALS CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | United Kingdom;Germany;Spain;Italy | |||
| 2 | EUCTR2005-000343-28-DE (EUCTR) | 19/12/2005 | 10/05/2005 | 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) | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Spain;Germany;Italy;United Kingdom | |||
| 3 | EUCTR2004-000596-34-HU (EUCTR) | 30/09/2005 | 08/06/2005 | 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. | 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 Program | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 4 | EUCTR2005-000343-28-GB (EUCTR) | 05/09/2005 | 28/06/2005 | 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) | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Germany;United Kingdom;Spain;Italy | |||
| 5 | EUCTR2004-000596-34-ES (EUCTR) | 01/09/2005 | 05/07/2005 | 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. | 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2004-000596-34-IT (EUCTR) | 01/06/2005 | 20/06/2005 | 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) | 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 CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 7 | EUCTR2004-000596-34-CZ (EUCTR) | 19/05/2005 | 06/05/2005 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 8 | NCT00683969 (ClinicalTrials.gov) | August 2004 | 19/5/2008 | A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of 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 Corticosteroid in Subjects With Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: mycophenolate mofetil (CellCept);Drug: placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;United Kingdom |
| 9 | NCT00408213 (ClinicalTrials.gov) | June 2004 | 5/12/2006 | A 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 Prednisone | Myasthenia Gravis Generalised | Drug: mycophenolate mofetil [CellCept];Drug: Placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00618527 (ClinicalTrials.gov) | August 2006 | 6/2/2008 | Combination Therapy Using Cellcept and Rebif in RRMS | Combination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple Sclerosis | Multiple Sclerosis | Drug: mycophenolate mofetil (Cellcept);Drug: human interferon beta 1a (Rebif) | Aaron Boster | EMD Serono;Pfizer | Completed | 18 Years | 65 Years | Both | 31 | Phase 0 | United States |
| 2 | NCT00324506 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis | A 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 Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (CellCept) | University of Texas Southwestern Medical Center | Aspreva Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 43 | Phase 2 | United States |
| 3 | NCT00223301 (ClinicalTrials.gov) | July 2004 | 19/9/2005 | Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis | A 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 Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (cellcept) | University of Texas Southwestern Medical Center | Roche Pharma AG;Biogen Idec | Completed | 21 Years | 45 Years | Both | 24 | Phase 2;Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-004668-71-ES (EUCTR) | 13/10/2016 | 05/08/2016 | A study of treatment for polyarteritis nodosa in children | An 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 London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2013-004668-71-IT (EUCTR) | 01/08/2016 | 14/07/2015 | A study of treatment for polyarteritis nodosa in children | An 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 London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Italy;United Kingdom;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2013-004668-71-GB (EUCTR) | 25/09/2014 | 25/09/2014 | A study of treatment for polyarteritis nodosa in children | An 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 London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Croatia;Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2013-004668-71-BE (EUCTR) | 12/04/2017 | A study of treatment for polyarteritis nodosa in children | An 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 London | NULL | NA | Female: yes Male: yes | 40 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden | |||
| 5 | EUCTR2013-004668-71-PT (EUCTR) | 16/02/2016 | A study of treatment for polyarteritis nodosa in children | An 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 London | NULL | NA | Female: yes Male: yes | 40 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Poland;Belgium;Croatia;Germany;Netherlands;Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2006-001663-33-IT (EUCTR) | 09/06/2008 | 28/05/2008 | A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC | A 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 Clinic | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Spain;Austria;Germany;United Kingdom;Italy;Sweden | |||
| 2 | EUCTR2006-001663-33-SE (EUCTR) | 13/05/2008 | 19/03/2008 | A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC | A 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 ANCA | Trade 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 Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Germany;United Kingdom;France;Spain;Italy;Austria;Sweden | |||
| 3 | NCT00405860 (ClinicalTrials.gov) | December 2002 | 29/11/2006 | CellCept in p-ANCA Vasculitis | A Pilot Study of Mycophenolate Mofetil (MMF) in Patients With p-ANCA Microscopic Polyangiitis and Mild to Moderate Renal Dysfunction. | MPO-ANCA Vasculitis;Microscopic Polyangiitis | Drug: CellCept (mycophenolate mofetil) | Mayo Clinic | Roche Pharma AG | Completed | 18 Years | N/A | Both | 18 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2005-004575-37-GB (EUCTR) | 14/03/2008 | 08/10/2008 | 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). | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 2 | EUCTR2005-004575-37-BE (EUCTR) | 21/11/2007 | 15/06/2007 | 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). | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 3 | EUCTR2005-004575-37-FR (EUCTR) | 27/04/2007 | 26/03/2007 | 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). | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 2;Phase 3 | United Kingdom;Belgium;France | ||
| 4 | NCT00594932 (ClinicalTrials.gov) | November 2006 | 4/1/2008 | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Systemic Lupus Erythematosus;Arthritis | Drug: mycophenolate mofetil;Other: placebo | Oklahoma Medical Research Foundation | NYU Langone Health | Completed | 14 Years | 70 Years | All | 27 | Phase 1;Phase 2 | United States |