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 | EUCTR2008-005476-27-GR (EUCTR) | 15/06/2010 | 17/12/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 2 | EUCTR2008-008008-42-GR (EUCTR) | 15/06/2010 | 04/12/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 3 | EUCTR2008-005479-82-GR (EUCTR) | 20/04/2010 | 04/12/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 4 | EUCTR2008-005476-27-GB (EUCTR) | 08/03/2010 | 11/09/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 5 | EUCTR2008-005479-82-AT (EUCTR) | 17/12/2009 | 02/12/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 6 | EUCTR2008-005479-82-GB (EUCTR) | 16/12/2009 | 11/09/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 7 | EUCTR2008-008008-42-GB (EUCTR) | 16/12/2009 | 11/09/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 8 | EUCTR2008-008008-42-DE (EUCTR) | 24/11/2009 | 17/04/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859 | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Denmark;Peru;Netherlands;Germany;Norway;Sweden | |||
| 9 | EUCTR2008-005479-82-DE (EUCTR) | 24/11/2009 | 17/04/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 10 | EUCTR2008-005476-27-DE (EUCTR) | 24/11/2009 | 17/04/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 11 | EUCTR2008-008008-42-DK (EUCTR) | 10/11/2009 | 30/09/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Hungary;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 12 | EUCTR2008-005479-82-DK (EUCTR) | 28/10/2009 | 30/09/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 13 | EUCTR2008-005476-27-DK (EUCTR) | 28/10/2009 | 28/09/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Sweden | |||
| 14 | EUCTR2008-005479-82-SE (EUCTR) | 16/07/2009 | 16/06/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 15 | EUCTR2008-005476-27-SE (EUCTR) | 16/07/2009 | 18/06/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 16 | EUCTR2008-008008-42-SE (EUCTR) | 16/07/2009 | 16/06/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) 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] - Musculoskeletal Diseases [C05] | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Swaziland;Canada;Argentina;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 17 | EUCTR2008-005479-82-ES (EUCTR) | 12/06/2009 | 05/03/2009 | Estudio doble ciego, randomizado, controlado con placebo, con diseño de retirada en la prevención de brotes con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301 | Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas. MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 18 | EUCTR2008-008008-42-ES (EUCTR) | 12/06/2009 | 01/04/2009 | Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1 | Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1 | Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 19 | EUCTR2008-005479-82-BE (EUCTR) | 04/06/2009 | 14/04/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Spain;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 20 | EUCTR2008-005476-27-BE (EUCTR) | 04/06/2009 | 27/04/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 21 | EUCTR2008-005476-27-ES (EUCTR) | 14/05/2009 | 03/03/2009 | Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305 | Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305 | Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas. MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 22 | EUCTR2008-008008-42-FR (EUCTR) | 07/05/2009 | 19/03/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 23 | EUCTR2008-005476-27-FR (EUCTR) | 07/05/2009 | 19/03/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 24 | EUCTR2008-005479-82-FR (EUCTR) | 07/05/2009 | 19/03/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 25 | EUCTR2008-005479-82-HU (EUCTR) | 05/05/2009 | 06/04/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 26 | EUCTR2008-005476-27-HU (EUCTR) | 04/05/2009 | 07/04/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 27 | EUCTR2008-008008-42-NO (EUCTR) | 10/03/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 88 | Phase 3 | Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 28 | EUCTR2008-005479-82-NO (EUCTR) | 12/03/2009 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 29 | EUCTR2008-005476-27-NO (EUCTR) | 09/03/2009 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 | Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Canakinumab Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden |