49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | EUCTR2010-024069-30-BG (EUCTR) | 21/08/2012 | 08/08/2012 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.1;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] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Netherlands;Germany | ||
| 2 | EUCTR2010-024069-30-DE (EUCTR) | 21/12/2011 | 19/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.1;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] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany | ||
| 3 | EUCTR2010-024069-30-NL (EUCTR) | 05/08/2011 | 04/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.0;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: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 544 | Phase 2 | Hungary;Germany;Netherlands;France;Chile;Italy;South Africa;Brazil;India;United Kingdom;Canada;Peru;Mexico;Argentina;Romania;Spain;Thailand;United States;Philippines;Poland | ||
| 4 | EUCTR2010-024069-30-IT (EUCTR) | 05/07/2011 | 19/01/2012 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.1;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] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 544 | Phase 2 | United States;Philippines;Spain;Thailand;Chile;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Brazil;Peru;Bulgaria;South Africa;Germany;Netherlands | ||
| 5 | EUCTR2010-024069-30-ES (EUCTR) | 19/05/2011 | 19/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 13.1;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] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 544 | Phase 2 | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Netherlands | ||
| 6 | EUCTR2010-024069-30-GB (EUCTR) | 18/05/2011 | 13/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.1;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] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Romania;Peru;Bulgaria;South Africa;Netherlands;Germany;Brazil;United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland | ||
| 7 | NCT01283139 (ClinicalTrials.gov) | March 31, 2011 | 20/1/2011 | A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | 75 Years | All | 834 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;United Kingdom |
| 8 | NCT00979654 (ClinicalTrials.gov) | August 2010 | 17/9/2009 | A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis | A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis | Systemic Lupus Erythematosus | Drug: Sifalimumab | MedImmune LLC | PPD | Completed | 18 Years | 99 Years | All | 118 | Phase 2 | United States;Brazil;Canada;Chile |
| 9 | EUCTR2010-024069-30-HU (EUCTR) | 17/05/2011 | A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 14.1;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] | Product Name: Sifalimumab Product Code: MEDI-545 INN or Proposed INN: sifalimumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Philippines;Spain;Thailand;Chile;Italy;United Kingdom;India;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Netherlands;Germany |