Gsk1841157 (DrugBank: -)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 5 |
| 35 | 天疱瘡 | 5 |
| 46 | 悪性関節リウマチ | 4 |
| 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 | EUCTR2011-002333-19-CZ (EUCTR) | 27/02/2012 | 31/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy | |||
| 2 | EUCTR2011-002333-19-DE (EUCTR) | 29/11/2011 | 09/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 15.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy | |||
| 3 | EUCTR2011-002333-19-DK (EUCTR) | 25/11/2011 | 18/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 4 | EUCTR2011-002333-19-NL (EUCTR) | 23/11/2011 | 05/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;Italy | |||
| 5 | EUCTR2011-002333-19-ES (EUCTR) | 21/10/2011 | 28/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 196 | Germany;Czech Republic;Russian Federation;Canada;Netherlands;Denmark;Bulgaria;Norway;Spain;Italy;United States |
| 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 | EUCTR2013-001370-20-PL (EUCTR) | 03/07/2015 | 23/04/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2013-001370-20-FR (EUCTR) | 20/04/2015 | 13/07/2015 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of | |||
| 3 | EUCTR2013-001370-20-GR (EUCTR) | 12/12/2014 | 11/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 4 | EUCTR2013-001370-20-IT (EUCTR) | 26/11/2014 | 25/08/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Glaxo Group Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 5 | EUCTR2013-001370-20-HR (EUCTR) | 17/11/2014 | 02/12/2014 | Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris | OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris | Pemphigus Vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of |
| 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 | EUCTR2008-002046-27-DE (EUCTR) | 08/12/2008 | 08/07/2008 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1;Phase 2A | Germany;Belgium;France;Spain | ||
| 2 | EUCTR2008-002046-27-BE (EUCTR) | 05/11/2008 | 17/09/2008 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 1;Phase 2A | Germany;Belgium;France;Spain | ||
| 3 | EUCTR2008-002046-27-ES (EUCTR) | 14/10/2008 | 06/05/2010 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato. | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato. | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1;Phase 2A | Germany;Belgium;France;Spain | ||
| 4 | EUCTR2008-002046-27-FR (EUCTR) | 05/09/2008 | 15/07/2008 | OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1;Phase 2 | France;Spain;Belgium;Germany |