160. 先天性魚鱗癬 Congenital ichthyosis Clinical trials / Disease details
臨床試験数 : 36 / 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
| 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 | EUCTR2016-001948-19-IT (EUCTR) | 05/09/2017 | 25/05/2021 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sj¿grens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sj¿grens Syndrome - - | Adults with moderately to severely Active Primary Sjogrens Syndrome MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: 00305800 | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Czechia;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Korea, Republic of;Sweden | ||
| 2 | EUCTR2016-001948-19-SE (EUCTR) | 02/02/2017 | 19/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2016-001948-19-CZ (EUCTR) | 28/12/2016 | 27/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | ||
| 4 | EUCTR2016-001948-19-FR (EUCTR) | 02/12/2016 | 07/11/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Sweden;Korea, Republic of |