107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details
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
Showing 1 to 10 of 14 diseases
| 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 | JPRN-jRCT2031220187 | 01/08/2022 | 07/07/2022 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumabin Children and Adults With MAS i ... | A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's Disease (Including Systemic Juvenile Idiopathic Arthritis and Adult Onset Still's Disease) or with MAS in Systemic Lupus Erythematosus - EMERALD A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerabilit ... | Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, SLE | Emapalumab iv infusion initial dose: 6 mg/kg Subsequent doses: 3 mg/kg | Nakaoku Takahiro | NULL | Recruiting | >= 6month old | <= 80age old | Both | 2 | Phase 2-3 | Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;United States;Japan Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;Uni ... |
| 2 | EUCTR2021-001577-24-ES (EUCTR) | 15/12/2021 | 25/08/2021 | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ... | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ... | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJI ... | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ... | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Ger ... | ||
| 3 | EUCTR2021-001577-24-PL (EUCTR) | 31/10/2021 | 28/09/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of ema ... | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ... | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJI ... | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ... | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany;China;Japan;Sweden United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Pol ... | ||
| 4 | EUCTR2016-004223-23-NL (EUCTR) | 09/08/2018 | 13/02/2018 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idi ... | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ... | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ... | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | France;United States;Canada;Spain;Germany;Netherlands;United Kingdom;Italy | ||
| 5 | NCT03311854 (ClinicalTrials.gov) | February 20, 2018 | 21/8/2017 | A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With ... | A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFN?) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetic ... | Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset Still Disease Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset S ... | Drug: Emapalumab | Swedish Orphan Biovitrum | NULL | Completed | N/A | N/A | All | 14 | Phase 2 | United States;France;Italy;Spain;United Kingdom;Netherlands |
| 6 | EUCTR2016-004223-23-ES (EUCTR) | 25/09/2017 | 09/06/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idi ... | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ... | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ... | Product Code: NI-0501 INN or Proposed INN: Emapalumab Other descriptive name: NI-0501 | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2016-004223-23-GB (EUCTR) | 12/09/2017 | 02/03/2017 | A study to investigate a new medication, emapalumab, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) A study to investigate a new medication, emapalumab, in children with the disease systemic Juvenile ... | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ... | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ... | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB | Swedish Orphan Biovitrum AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Canada;Spain;Netherlands;Italy;United Kingdom | ||
| 8 | EUCTR2021-001577-24-BE (EUCTR) | 27/10/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics of emapalumab in children and adults with macrophage activation syndrome (MAS) A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics of emap ... | A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still’s disease) or with MAS in Systemic Lupus Erythematous - NI-0501-14 A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerabilit ... | Macrophage activation syndrome (MAS) in the context of Systemic Juvenile Idiopathic Arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic Lupus Erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome (MAS) in the context of Systemic Juvenile Idiopathic Arthritis (sJIA) ... | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ... | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Bel ... | |||
| 9 | EUCTR2021-001577-24-IT (EUCTR) | 16/09/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of ema ... | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ... | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJI ... | Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Profilassi per Herpes Zoster Product Code: [Profilassi per Herpes Zoster] INN or Proposed INN: Antivirale ad uso diretto Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Emapalum ... | Swedish Orphan Biovitrum AG | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Bel ... | |||
| 10 | EUCTR2021-001577-24-NL (EUCTR) | 21/04/2022 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of ema ... | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ... | Macrophage activation syndrome (MAS) in the context of Systemic juvenile idiopathic arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Macrophage activation syndrome (MAS) in the context of Systemic juvenile idiopathic arthritis (sJIA) ... | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ... | Swedish Orphan Biovitrum AG (Sobi AG) | NULL | NA | Female: yes Male: yes | 41 | Phase 2;Phase 3 | United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Bel ... |