11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 315 / 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
| 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 | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | Hungary;Czech Republic;Spain;Italy | ||
| 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 |