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
| 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 | NCT03841357 (ClinicalTrials.gov) | October 29, 2019 | 30/1/2019 | Preventing 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 Arthritis | Drug: Abatacept Injection;Other: Usual Care | Duke University | NULL | Recruiting | 2 Years | 16 Years | All | 306 | Phase 3 | United States |
| 2 | NCT02840175 (ClinicalTrials.gov) | May 18, 2017 | 19/7/2016 | Treatment Tapering in JIA With Inactive Disease | Treatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic Therapy | Juvenile Idiopathic Arthritis | Drug: etanercept;Drug: adalimumab;Drug: Abatacept;Drug: Tocilizumab | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 2 Years | 17 Years | All | 62 | Phase 3 | France |
| 3 | JPRN-UMIN000024178 | 2016/09/28 | 28/09/2016 | Efficacy 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 weeks | Yokohama City University Hospital Department of Pediatrics | NULL | Recruiting | 2years-old | Not applicable | Male and Female | 5 | Not selected | Japan | |
| 4 | EUCTR2016-000312-15-FR (EUCTR) | 12/08/2016 | 17/06/2016 | Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM | Treatment 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) | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | France | ||
| 5 | EUCTR2013-003956-18-NL (EUCTR) | 29/04/2014 | 13/01/2014 | Prevention 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 Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | United States;Canada;Latvia;Germany;Netherlands | |||
| 6 | EUCTR2012-003195-39-IT (EUCTR) | 08/10/2013 | 22/07/2013 | 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) | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 7 | EUCTR2012-003195-39-BE (EUCTR) | 07/10/2013 | 09/07/2013 | 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) | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 8 | EUCTR2012-003195-39-ES (EUCTR) | 17/09/2013 | 12/07/2013 | 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) | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;United States;Mexico;Argentina;Brazil;Belgium;Spain;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 9 | JPRN-JapicCTI-132119 | 12/9/2013 | 07/05/2013 | Efficacy, 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. | complete | 4 | 17 | BOTH | 20 | Phase 3 | Japan |
| 10 | EUCTR2012-003195-39-DE (EUCTR) | 26/08/2013 | 08/07/2013 | 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) | 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;France;Mexico;Argentina;Spain;Brazil;Belgium;Peru;South Africa;Russian Federation;Germany;Italy | ||
| 11 | NCT01835470 (ClinicalTrials.gov) | August 9, 2013 | 17/4/2013 | Efficacy, 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 | Drug: Abatacept | Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd | Completed | 4 Years | 17 Years | All | 23 | Phase 3 | Japan |
| 12 | NCT01844518 (ClinicalTrials.gov) | June 28, 2013 | 29/4/2013 | 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) | 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 Arthritis | Biological: Abatacept | Bristol-Myers Squibb | NULL | Active, not recruiting | 2 Years | 17 Years | All | 187 | Phase 3 | United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation;South Africa;Spain |
| 13 | EUCTR2012-003195-39-Outside-EU/EEA (EUCTR) | 14/11/2013 | 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) | 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 Corporation | NULL | NA | Female: yes Male: yes | 210 | Phase 3 | South Africa;Spain;United States;Argentina;Belgium;Brazil;France;Germany;Italy;Mexico;Peru;Russian Federation | |||
| 14 | EUCTR2012-003195-39-FR (EUCTR) | 29/09/2015 | 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) | 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 Corporation | NULL | NA | Female: yes Male: yes | 210 | Phase 3 | United States;France;Mexico;Argentina;Brazil;Belgium;Spain;Peru;Russian Federation;South Africa;Germany;Italy | |||
| 15 | EUCTR2016-000940-32-Outside-EU/EEA (EUCTR) | 28/04/2016 | Efficacy, 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 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 Corporation | NULL | NA | Female: yes Male: yes | 23 | Phase 3 | Japan |