GSK1841157 ( DrugBank: - )


3 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica5
35Pemphigus5
46Malignant rheumatoid arthritis4

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,342 Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-002333-19-CZ
(EUCTR)
27/02/201231/10/2011Subcutaneous 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy
2EUCTR2011-002333-19-DE
(EUCTR)
29/11/201109/09/2011Subcutaneous 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy
3EUCTR2011-002333-19-DK
(EUCTR)
25/11/201118/10/2011Subcutaneous 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
196Phase 2United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy
4EUCTR2011-002333-19-NL
(EUCTR)
23/11/201105/10/2011Subcutaneous 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;Italy
5EUCTR2011-002333-19-ES
(EUCTR)
21/10/201128/09/2011Subcutaneous 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 SANULLNot RecruitingFemale: yes
Male: yes
196Phase 2United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy

35. Pemphigus


Clinical trials : 98 Drugs : 126 - (DrugBank : 41) / Drug target genes : 23 - Drug target pathways : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-001370-20-PL
(EUCTR)
03/07/201523/04/2015Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
2EUCTR2013-001370-20-FR
(EUCTR)
20/04/201513/07/2015Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of
3EUCTR2013-001370-20-GR
(EUCTR)
12/12/201411/12/2014Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
4EUCTR2013-001370-20-IT
(EUCTR)
26/11/201425/08/2014Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
5EUCTR2013-001370-20-HR
(EUCTR)
17/11/201402/12/2014Study of subcutaneous Ofatumumab Injections for Pemphigus VulgarisOPV116910: 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 AGNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of

46. Malignant rheumatoid arthritis


Clinical trials : 4,325 Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-002046-27-DE
(EUCTR)
08/12/200808/07/2008Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose MethotrexateClinical 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 LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 1/2Germany;Belgium;France;Spain
2EUCTR2008-002046-27-BE
(EUCTR)
05/11/200817/09/2008Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose MethotrexateClinical 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 LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 1/2Germany;Belgium;France;Spain
3EUCTR2008-002046-27-ES
(EUCTR)
14/10/200806/05/2010Clinical 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.NULLNot RecruitingFemale: yes
Male: yes
70Phase 1/2Germany;Belgium;France;Spain
4EUCTR2008-002046-27-FR
(EUCTR)
05/09/200815/07/2008OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose MethotrexateOFA110867 : 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 LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 1;Phase 2France;Spain;Belgium;Germany