CellCept 500 mg ( DrugBank: - )


1 disease
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5

11. 重症筋無力症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-000343-28-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
2EUCTR2004-000596-34-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
3EUCTR2005-000343-28-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
4EUCTR2004-000596-34-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 LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3Hungary;Czech Republic;Spain;Italy
5EUCTR2004-000596-34-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