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
Showing 1 to 10 of 15 diseases
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 | NCT04060888 (ClinicalTrials.gov) | July 14, 2020 | 16/8/2019 | A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin C ... | Lupus Erythematosus, Systemic | Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: Placebo | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 3 | China |
2 | EUCTR2017-001489-53-PT (EUCTR) | 04/02/2019 | 08/11/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | Systemic Lupus Erythematosus MedDRA version: 21.1;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] Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Col ... | ||
3 | EUCTR2017-001489-53-PL (EUCTR) | 24/09/2018 | 23/07/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | Systemic Lupus Erythematosus MedDRA version: 21.1;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] Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hu ... | ||
4 | JPRN-JapicCTI-183973 | 16/8/2018 | 29/05/2018 | A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | Lupus Erythematosus, Systemic | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160. Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the ... | Janssen Pharmaceutical K.K. | NULL | complete | 16 | 75 | BOTH | 500 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa |
5 | EUCTR2017-001489-53-BG (EUCTR) | 27/06/2018 | 28/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | 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] Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hu ... | ||
6 | EUCTR2017-001489-53-HU (EUCTR) | 14/06/2018 | 03/04/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | 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] Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation; ... | ||
7 | EUCTR2017-001489-53-ES (EUCTR) | 12/06/2018 | 14/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | 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] Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation; ... | ||
8 | EUCTR2017-001489-53-DE (EUCTR) | 08/05/2018 | 23/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | Systemic Lupus Erythematosus MedDRA version: 21.1;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] Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hu ... | ||
9 | EUCTR2017-001489-53-LT (EUCTR) | 07/05/2018 | 19/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | 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] Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Syste ... | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: St ... | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hu ... | ||
10 | NCT03517722 (ClinicalTrials.gov) | April 16, 2018 | 13/4/2018 | A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumabin S ... | Lupus Erythematosus, Systemic | Drug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mg | Janssen Research & Development, LLC | NULL | Terminated | 16 Years | 75 Years | All | 516 | Phase 3 | United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lith ... |