49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| 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 | EUCTR2017-001764-37-PT (EUCTR) | 14/05/2018 | 12/10/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 2 | NCT03407482 (ClinicalTrials.gov) | January 9, 2018 | 15/1/2018 | An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: GDC-0853 | Genentech, Inc. | NULL | Completed | 18 Years | 76 Years | All | 160 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;Germany;Portugal |
| 3 | EUCTR2017-001764-37-BG (EUCTR) | 15/12/2017 | 16/10/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 4 | EUCTR2017-001764-37-GB (EUCTR) | 14/11/2017 | 15/08/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 5 | EUCTR2017-001764-37-ES (EUCTR) | 07/11/2017 | 18/09/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 6 | EUCTR2016-001039-11-DE (EUCTR) | 03/04/2017 | 22/12/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 7 | EUCTR2016-001039-11-BG (EUCTR) | 20/02/2017 | 08/11/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITHMODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 8 | EUCTR2016-001039-11-ES (EUCTR) | 07/02/2017 | 26/10/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 9 | EUCTR2016-001039-11-PT (EUCTR) | 30/01/2017 | 23/09/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 10 | NCT02908100 (ClinicalTrials.gov) | January 19, 2017 | 14/9/2016 | A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GDC-0853;Drug: Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 260 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;France;Portugal;Thailand |
| 11 | EUCTR2016-001039-11-GB (EUCTR) | 16/11/2016 | 24/08/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of |