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 | EUCTR2018-003618-41-BE (EUCTR) | 05/08/2019 | 05/04/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2018-003618-41-PL (EUCTR) | 05/07/2019 | 13/05/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-003618-41-DE (EUCTR) | 01/07/2019 | 29/03/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-003618-41-GB (EUCTR) | 05/06/2019 | 28/03/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2018-003618-41-IT (EUCTR) | 09/05/2019 | 24/05/2021 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis - --- | Generalized Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: [M281] | MOMENTA PHARMACEUTICALS, Inc | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2018-003618-41-ES (EUCTR) | 02/04/2019 | 12/04/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2018-002247-28-BE (EUCTR) | 18/03/2019 | 05/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2018-002247-28-PL (EUCTR) | 27/02/2019 | 31/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2018-002247-28-GB (EUCTR) | 05/02/2019 | 30/11/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2018-002247-28-IT (EUCTR) | 04/02/2019 | 04/11/2020 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: [M281] INN or Proposed INN: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 11 | EUCTR2018-002247-28-ES (EUCTR) | 14/12/2018 | 18/01/2019 | To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy |