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 : 292 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142

  
11 trials found
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PhaseCountries
1EUCTR2021-001577-24-ES
(EUCTR)
15/12/202125/08/2021A 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 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 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
2EUCTR2021-001577-24-PL
(EUCTR)
31/10/202128/09/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)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 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Germany;Netherlands;China;Japan;Sweden
3EUCTR2016-004223-23-NL
(EUCTR)
09/08/201813/02/2018A 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 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) 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Novimmune SANULLNot RecruitingFemale: yes
Male: yes
10Phase 2France;United States;Canada;Spain;Germany;Netherlands;United Kingdom;Italy
4NCT03311854
(ClinicalTrials.gov)
February 20, 201821/8/2017A 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 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)Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset Still DiseaseDrug: EmapalumabSwedish Orphan BiovitrumNULLCompletedN/AN/AAll14Phase 2United States;France;Italy;Spain;United Kingdom;Netherlands
5EUCTR2016-004223-23-ES
(EUCTR)
25/09/201709/06/2017A 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 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) 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]
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Other descriptive name: NI-0501
Novimmune SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 2France;Spain;Netherlands;Germany;Italy;United Kingdom
6EUCTR2016-004223-23-GB
(EUCTR)
12/09/201702/03/2017A 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 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) 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Swedish Orphan Biovitrum AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Canada;Spain;Netherlands;Italy;United Kingdom
7EUCTR2021-001577-24-IT
(EUCTR)
16/09/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)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 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]
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
Swedish Orphan Biovitrum AGNULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
8EUCTR2021-001577-24-FR
(EUCTR)
27/08/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)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 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
9EUCTR2021-001577-24-SE
(EUCTR)
22/11/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)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 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden
10EUCTR2016-004223-23-FR
(EUCTR)
13/02/2017A 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 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) 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Other descriptive name: Fully human anti-interferon gamma monoclonal antibody
Novimmune SANULLNot RecruitingFemale: yes
Male: yes
10Phase 2United States;France;Canada;Spain;Netherlands;Italy;United Kingdom
11EUCTR2021-001577-24-CZ
(EUCTR)
18/10/2021A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS)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 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]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: Emapalumab
Swedish Orphan Biovitrum AG (Sobi AG)NULLNAFemale: yes
Male: yes
41Phase 2;Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden