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 | EUCTR2014-002184-14-NL (EUCTR) | 22/12/2015 | 03/09/2015 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 18.0;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: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 2 | EUCTR2014-002184-14-DE (EUCTR) | 26/02/2015 | 23/12/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 01 - Site Specific- dated-20-Aug-2014 | Active 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: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 3 | EUCTR2014-002184-14-IT (EUCTR) | 24/02/2015 | 09/01/2015 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 17.1;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: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Lulizumab Pegol Other descriptive name: Lulizumab Pegol | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 4 | EUCTR2014-002184-14-HU (EUCTR) | 16/02/2015 | 29/12/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 1 - Site Specific - dated-20-Aug-2014 | Active Systemic Lupus Erythematosus MedDRA version: 17.1;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: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 5 | EUCTR2014-002184-14-ES (EUCTR) | 26/12/2014 | 22/12/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 17.1;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: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy | ||
| 6 | NCT02265744 (ClinicalTrials.gov) | November 13, 2014 | 15/10/2014 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus | Lupus | Drug: BMS-931699;Drug: Placebo matching BMS-931699 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 70 Years | All | 730 | Phase 2 | United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar |