Ro 533-3787/F01-06 ( 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 | 2 |
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. | 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 | EUCTR2020-004436-21-DK (EUCTR) | 11/08/2021 | 11/03/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB Product Name: Satralizumab Product Code: Ro 533-3787/F01-06 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2020-004436-21-NL (EUCTR) | 05/08/2021 | 06/04/2021 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia Gravis | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS | Generalized Myasthenia Gravis (gMG) MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab Product Code: RO5333787 INN or Proposed INN: SATRALIZUMAB Product Name: Satralizumab Product Code: Ro 533-3787/F01-06 INN or Proposed INN: SATRALIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of |