0.7mL prefilled syringes ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
107若年性特発性関節炎6

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
1EUCTR2012-003195-39-IT
(EUCTR)
08/10/201322/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03. Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy
2EUCTR2012-003195-39-BE
(EUCTR)
07/10/201309/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11Site specific Protocol Amendment 13 dated 17-July-2015 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy
3EUCTR2012-003195-39-ES
(EUCTR)
17/09/201312/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy
4EUCTR2012-003195-39-DE
(EUCTR)
26/08/201308/07/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11Site specific Protocol Amendment 13 dated 17-July-2015Site specific Protocol Amendment 12 dated 02-July-2015 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 18.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy
5EUCTR2012-003195-39-FR
(EUCTR)
29/09/2015Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 01 incorporating Amendment 03 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNAFemale: yes
Male: yes
210Phase 3United States;France;Mexico;Argentina;Brazil;Belgium;Spain;Peru;Russian Federation;South Africa;Germany;Italy
6EUCTR2012-003195-39-Outside-EU/EEA
(EUCTR)
14/11/2013Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Revised Protocol 03 incorporating Amendment 11 Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
MedDRA version: 17.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 1mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.7mL prefilled syringes
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: 0.4mL prefilled syringes
Bristol-Myers Squibb International CorporationNULLNAFemale: yes
Male: yes
210Phase 3South Africa;Spain;United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation