13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2009-010788-18-NL (EUCTR) | 07/06/2010 | 18/09/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Serbia;United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 2 | EUCTR2009-010788-18-CZ (EUCTR) | 02/11/2009 | 14/09/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 3 | EUCTR2009-010788-18-GB (EUCTR) | 01/07/2009 | 13/07/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2006-002037-20-CZ (EUCTR) | 13/10/2006 | 28/08/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 5 | EUCTR2006-002037-20-BE (EUCTR) | 27/09/2006 | 19/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 6 | EUCTR2006-002037-20-GB (EUCTR) | 07/09/2006 | 23/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 7 | EUCTR2006-002037-20-DE (EUCTR) | 07/09/2006 | 20/10/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Czech Republic;United Kingdom;Germany;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 8 | EUCTR2006-002037-20-HU (EUCTR) | 27/07/2006 | 23/05/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 9 | EUCTR2006-002037-20-FI (EUCTR) | 12/07/2006 | 15/06/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Phase 3 | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom |