107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142

  
15 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT03841357
(ClinicalTrials.gov)
October 29, 201930/1/2019Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)A Randomized, Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)Juvenile Idiopathic ArthritisDrug: Abatacept Injection;Other: Usual CareDuke UniversityNULLRecruiting2 Years16 YearsAll306Phase 3United States
2NCT02840175
(ClinicalTrials.gov)
May 18, 201719/7/2016Treatment Tapering in JIA With Inactive DiseaseTreatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic TherapyJuvenile Idiopathic ArthritisDrug: etanercept;Drug: adalimumab;Drug: Abatacept;Drug: TocilizumabAssistance Publique - Hôpitaux de ParisNULLCompleted2 Years17 YearsAll62Phase 3France
3JPRN-UMIN000024178
2016/09/2828/09/2016Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis Systemic-onset juvenile idiopathic arthritis(sJIA)Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeksYokohama City University Hospital Department of PediatricsNULLRecruiting2years-oldNot applicableMale and Female5Not selectedJapan
4EUCTR2016-000312-15-FR
(EUCTR)
12/08/201617/06/2016Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREMTreatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology.
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: ENBREL
Product Name: ENBREL
INN or Proposed INN: Etanercept
Other descriptive name: Etanercept
Trade Name: HUMIRA
Product Name: HUMIRA
INN or Proposed INN: adalimumab
Other descriptive name: adalimumab
Trade Name: ROACTEMRA
Product Name: ROACTEMRA
INN or Proposed INN: tocilizumab
Other descriptive name: tocilizumab
Trade Name: ORENCIA
Product Name: ORENCIA
INN or Proposed INN: abatacept
Other descriptive name: abatacept
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
230Phase 3France
5EUCTR2013-003956-18-NL
(EUCTR)
29/04/201413/01/2014Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA)Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA) - PREVENT-JIA juvenile idiopathic arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: enbrel
Product Name: enbrel
Product Code: EU/1/99/126/001
INN or Proposed INN: ETANERCEPT
Other descriptive name: enbrel
Trade Name: humira
Product Name: humira
Product Code: EU/1/03/256/001
INN or Proposed INN: ADALIMUMAB
Other descriptive name: humira
Trade Name: orencia
Product Name: orencia
Product Code: EU/1/07/389/001
INN or Proposed INN: ABATACEPT
Other descriptive name: orencia
Trade Name: methotrexate
Product Name: methotrexate
Product Code: RVG 28636
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
Trade Name: methotrexate
Product Name: Methotrexate
Product Code: RVG 104433
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325United States;Canada;Latvia;Germany;Netherlands
6EUCTR2012-003195-39-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
7EUCTR2012-003195-39-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
8EUCTR2012-003195-39-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
9JPRN-JapicCTI-132119
12/9/201307/05/2013Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan.A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics. Juvenile Idiopathic Arthritis.Intervention name : Abatacept
INN of the intervention : Abatacept
Dosage And administration of the intervention : Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Bristol-Myers Squibb K.K.Ono Pharmaceutical Co., Ltd.complete417BOTH20Phase 3Japan
10EUCTR2012-003195-39-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
11NCT01835470
(ClinicalTrials.gov)
August 9, 201317/4/2013Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in JapanA Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or BiologicsJuvenile Idiopathic ArthritisDrug: AbataceptBristol-Myers SquibbOno Pharmaceutical Co. LtdCompleted4 Years17 YearsAll23Phase 3Japan
12NCT01844518
(ClinicalTrials.gov)
June 28, 201329/4/2013Pharmacokinetics, 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)Active Polyarticular Juvenile Idiopathic ArthritisBiological: AbataceptBristol-Myers SquibbNULLActive, not recruiting2 Years17 YearsAll187Phase 3United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation;South Africa;Spain
13EUCTR2016-000940-32-Outside-EU/EEA
(EUCTR)
28/04/2016Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in JapanA Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents with Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response orIntolerance to Methotrexate or Biologics. Juvenile Idiopathic Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: ABATACEPT
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNAFemale: yes
Male: yes
23Phase 3Japan
14EUCTR2012-003195-39-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
15EUCTR2012-003195-39-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