Human anti-TNF-alpha monoclonal antibody ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ10
97潰瘍性大腸炎6
107若年性特発性関節炎6

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-015019-42-DE
(EUCTR)
10/05/201120/08/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands
2EUCTR2009-015019-42-BE
(EUCTR)
04/04/201106/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany
3EUCTR2009-015019-42-FI
(EUCTR)
17/11/201027/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands
4EUCTR2009-015019-42-LT
(EUCTR)
02/11/201017/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
5EUCTR2009-015019-42-AT
(EUCTR)
05/10/201001/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
6EUCTR2008-006064-11-HU
(EUCTR)
20/01/201027/10/2009A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
564Hungary;Lithuania
7EUCTR2008-006064-11-LT
(EUCTR)
30/12/200919/10/2009An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroidsA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
564United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of
8EUCTR2009-010582-23-AT
(EUCTR)
26/11/200912/10/2009Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
400Phase 3Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
9NCT00650390
(ClinicalTrials.gov)
October 200428/3/2008Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody AdalimumabOpen Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody AdalimumabRheumatoid ArthritisBiological: adalimumabAbbottNULLApproved for marketing18 YearsN/ABothN/ANULL
10EUCTR2009-015019-42-Outside-EU/EEA
(EUCTR)
08/03/2012Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNAFemale: yes
Male: yes
170Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-004366-18-BE
(EUCTR)
08/01/201427/06/2013A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK Ulcerative Colitis in pediatric subjects
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany
2EUCTR2012-004366-18-DE
(EUCTR)
17/12/201329/07/2013A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK Ulcerative Colitis in pediatric subjects
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany
3EUCTR2012-004366-18-DK
(EUCTR)
11/12/201303/12/2013A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK Ulcerative Colitis in pediatric subjects
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
30Phase 1United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands
4EUCTR2012-004366-18-NL
(EUCTR)
28/11/201316/08/2013A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK Ulcerative Colitis in pediatric subjects
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands
5EUCTR2012-004366-18-AT
(EUCTR)
30/07/201312/06/2013A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK Ulcerative Colitis in pediatric subjects
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany
6EUCTR2012-004366-18-FR
(EUCTR)
28/09/2015A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative ColitisA Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK Ulcerative Colitis in pediatric subjects
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNAFemale: yes
Male: yes
30Phase 1United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-015019-42-DE
(EUCTR)
10/05/201120/08/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands
2EUCTR2009-015019-42-BE
(EUCTR)
04/04/201106/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany
3EUCTR2009-015019-42-FI
(EUCTR)
17/11/201027/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands
4EUCTR2009-015019-42-LT
(EUCTR)
02/11/201017/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
5EUCTR2009-015019-42-AT
(EUCTR)
05/10/201001/09/2010Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
170Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
6EUCTR2009-015019-42-Outside-EU/EEA
(EUCTR)
08/03/2012Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNAFemale: yes
Male: yes
170Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico