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 107. 若年性特発性関節炎 [臨床試験数:45,薬物数:39(DrugBank:10),標的遺伝子数:13,標的パスウェイ数:80] 

Searched query = "Systemic juvenile idiopathic arthritis", "Systemic-onset juvenile idiopathic arthritis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
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PhaseCountries
1NCT04088396October 31, 201911 November 2019A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIARandomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic ArthritisSystemic Juvenile Idiopathic ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNot recruiting1 Year17 YearsAll103Phase 3Argentina;Austria;Belgium;Brazil;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom
2NCT03932344April 10, 20194 November 2019Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic ArthritisStill Disease, Juvenile OnsetDrug: AnakinraSwedish Orphan BiovitrumNot recruitingN/AN/AAll306N/AItaly
3NCT02991469August 9, 201811 November 2019A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension PhaseJuvenile Idiopathic ArthritisDrug: Sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsRecruiting1 Year17 YearsAll72Phase 2Argentina;Canada;Czechia;Finland;France;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Chile;Estonia;United States
4NCT03000439May 10, 201830 September 2019A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIAEFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTSArthritis Juvenile IdiopathicDrug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratioPfizerRecruiting2 Years17 YearsAll100Phase 3United States;Argentina;Brazil;Canada;Chile;China;Israel;Mexico;Russian Federation;South Africa;Turkey;Ukraine
5NCT03301883April 26, 20184 November 2019A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: Tocilizumab;Drug: NSAIDs;Drug: CSs;Drug: MTXHoffmann-La RocheRecruiting2 Years17 YearsAll74Phase 4China
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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sponsor
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agemin
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PhaseCountries
6NCT03311854March 2, 201826 August 2019A Study to Investigate the Safety and Efficacy of an Anti-IFN-gamma mAb in Children With 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;Lymphohistiocytosis, Hemophagocytic;Arthritis, JuvenileDrug: NI-0501NovImmune SARecruitingN/A18 YearsAll10Phase 2United States;France;Italy;Netherlands;Spain;United Kingdom
7ChiCTR-OPB-170137042017-12-2011 December 2017A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritisA phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritissystemic juvenile idiopathic arthritisCase series:Tocilizumab;Children's Hospital of Chongqing Medical UniversityRecruiting217BothCase series:65;Post-marketChina
8EUCTR2016-004223-23-ES25/09/20172 October 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Emapalumab
Current Sponsor code: NI-0501
Other descriptive name: NI-0501
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Novimmune SAAuthorisedFemale: yes
Male: yes
5Phase 2France;Spain;Netherlands;Germany;Italy;United Kingdom
9ChiCTR-INR-170118292017-08-013 July 2017Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumabMultiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumabSystemic onset juvenile idiopathic arthritisCase:Tocilizumab;Control:Conventional Treatment;Shenzhen Children's HospitalNot RecruitingBothCase:75;Control:75;New Treatment Measure Clinical StudyChina
10EUCTR2016-004223-23-IT14/04/201719 March 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: 19.1 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
Pharmaceutical Form: Concentrate for solution for infusion
Novimmune SAAuthorisedFemale: yes
Male: yes
5Phase 2France;Spain;Netherlands;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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Inclusion_
agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-004000-35-GB24/02/20177 May 2018A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension PhaseJuvenile Idiopathic Arthritis
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: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-
sanofi-aventis recherche & développementAuthorisedFemale: yes
Male: yes
72Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands
12EUCTR2015-004393-16-NL04/10/201624 October 2016Biomarker-guided treatment-and-stop-strategy for short acting IL-1 blockade in patients with systemic Juvenile Idiopathic Arthritis.Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis. - ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIAsystemic Juvenile Idiopathic Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: kineret® or anakinra
Product Name: anakinra / kineret
Product Code: not applicable
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Current Sponsor code: Anakinra
Other descriptive name: rIL-1RA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
University Medical Center UtrechtAuthorisedFemale: yes
Male: yes
Phase 4Netherlands
13JPRN-UMIN0000241782016/09/282 April 2019Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritisSystemic-onset juvenile idiopathic arthritis(sJIA)Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeksYokohama City University Hospital Department of PediatricsRecruiting2years-oldNot applicableMale and Female5Not selectedJapan
14ChiCTR-OPC-170113912016-09-0122 May 2017The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in ChinaThe efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in Chinasystemic juvenile idiopathic arthritistocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid;Children's Hospital of Chongqing Medical UniversityNot Recruiting216Bothtocilizumab group:36;glucocorticoid group:24;Post-marketChina
15EUCTR2016-004223-23-FR23 July 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: 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
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: EMAPALUMAB
Current Sponsor code: NI-0501
Other descriptive name: Fully human anti-interferon gamma monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Novimmune SANot AvailableFemale: yes
Male: yes
10Phase 2United States;France;Canada;Spain;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02396212May 7, 20151 October 2018Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIAAn Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisBiological: CanakinumabNovartis PharmaceuticalsNot recruiting2 Years19 YearsAll19Phase 3Japan
17ChiCTR-OOC-150062282015-04-0118 April 2017Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritisClinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritissystemic-onset juvenile idiopathic arthritisdisease active group,disease remission group:add heparin into neutrophils in vitro;Shanghai Children's Medical CenterRecruiting316Bothdisease active group,disease remission group:30;OtherChina
18JPRN-JapicCTI-15286501/4/20152 April 2019Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIAAn Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisIntervention name : ACZ885
INN of the intervention : Canakinumab
Dosage And administration of the intervention : 4mg/kg every 4 weeks
Control intervention name : null
Novartis Pharma K.K.219BOTH20Phase 3
19EUCTR2015-004000-35-FR28 February 2019A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension PhaseJuvenile 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] - Immune System Diseases [C20]
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-
sanofi-aventis recherche & développementNot Recruiting Female: yes
Male: yes
36Phase 2United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany
20NCT02334748November 3, 201421 January 2019A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 StudiesA French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)Systemic Juvenile Idiopathic Arthritis;Hereditary Periodic FeversDrug: canakinumabNovartis PharmaceuticalsNot recruitingN/AN/AAll31Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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gender
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size
PhaseCountries
21EUCTR2014-002872-95-FR15/09/201410 September 2018A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1A French open-label extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who participated in the international phase III study CACZ885G2301E1 - CACZ885GFR01Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations
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] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Novartis Pharma S.A.SNot RecruitingFemale: yes
Male: yes
15Phase 4France
22EUCTR2013-004867-29-SE10/09/201420 August 2018ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
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: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
23NCT02165345July 16, 201430 September 2019Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic ArthritisLong-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNot recruiting2 Years18 YearsAll82Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
24EUCTR2013-005212-98-DE30/06/201418 June 2018Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic ArthritisLONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITISPolyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA)
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] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
104Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
25EUCTR2012-003490-26-DE08/08/20132 October 2017A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITISSystemic Juvenile Idiopathic Arthritis (sJIA)
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] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01676948January 201326 October 2015An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisDrug: ACZ885;Drug: CanakinumabNovartis PharmaceuticalsPRINTO/PRCSGNot recruiting2 Years20 YearsBoth0Phase 3Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
27EUCTR2012-000444-10-GB09/11/201214 March 2016A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMABSystemic juvenile idiopathic arthritis (sJIA)
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] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes
43Phase 4Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom;Sweden
28NCT01455701October 26, 201211 November 2019A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)Juvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNot recruitingN/A24 MonthsAll11Phase 1United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;United Kingdom
29NCT00891046September 20091 April 2019An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.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 Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without FeverSystemic Juvenile Idiopathic ArthritisDrug: CanakinumabNovartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationNot recruiting2 Years19 YearsAll270Phase 3United States;Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Peru;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;Denmark;Norway;South Africa
30NCT00868751March 200916 December 2017Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic ArthritisSingle Patient Use of Tocilizumab for Treatment of Steroid Dependent, Active Systemic Onset Juvenile Idiopathic ArthritisArthritis, Juvenile Rheumatoid;Still's Disease, Juvenile OnsetBiological: tocilizumabTufts Medical CenterHoffmann-La RocheNot recruiting2 Years16 YearsAll1N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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Inclusion_
agemin
Inclusion_
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Inclusion_
gender
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size
PhaseCountries
31NCT00534495November 200819 October 2017Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young AdultsRandomized Placebo Phase Study of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT)Juvenile Idiopathic ArthritisBiological: RilonaceptMontefiore Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Months19 YearsAll71Phase 2United States
32JPRN-UMIN0000014572008/10/012 April 2019The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trialAdult Still's disease and systemic juvenile idiopathic arthritisTocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weightDivision of Rheumatology & Clinical Immunology, Jichi Medical UniversityNot Recruiting16years-oldNot applicableMale and Female10Not selectedJapan
33JPRN-UMIN0000012502008/07/012 April 2019Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trialAdult Still's disease or systemic juvenile idiopathic arthritisTocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks.Division of Rheumatology & Clinical Immunology, Jichi Medical UniversityNot Recruiting16years-oldNot applicableMale and Female10Not selectedJapan
34EUCTR2007-000872-18-BE15/04/200817 August 2015The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDERSystemic 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 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche Ltd.Not RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
35EUCTR2008-008008-42-NO2 October 2017An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1Active 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGNot AvailableFemale: yes
Male: yes
88Phase 3Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-001834-42-FR17/04/200710 July 2015A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 8.1 Level: PT Classification code 10059177 Term: Juvenile arthritis
Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ACZ885 Drug Substance
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
26France;United Kingdom;Italy
37NCT00426218December 200619 February 2015Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Arthritis, Juvenile RheumatoidDrug: ACZ885NovartisNot recruiting4 Years20 YearsBoth26Phase 1/Phase 2Italy
38EUCTR2006-000089-35-IT17/08/200619 March 2012Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - NDPhase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - NDsystemic onset juvenile idiopathic arthritis
Level: PT Classification code 10059177
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
ITALFARMACONot RecruitingFemale: yes
Male: yes
16Phase 2Italy
39NCT00339157June 200619 February 2015Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITISANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)Systemic-Onset Juvenile Idiopathic ArthritisDrug: Anakinra;Biological: Pneumo23Institut National de la Santé Et de la Recherche Médicale, FranceNot recruiting2 Years20 YearsBoth24Phase 2/Phase 3France
40NCT01803321November 200519 February 2015Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisDrug: rilonacept (IL-1 Trap);Other: PlaceboRegeneron PharmaceuticalsNot recruiting4 Years20 YearsBoth24Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2005-004008-36-IT27/10/200518 April 2012Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritisEfficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritisCINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis
MedDRA version: 14.1 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anakinra
Concentration unit: mg milligram(s)
Concentration number: 100-
ISTITUTO GIANNINA GASLININot RecruitingFemale: yes
Male: yes
Italy
42NCT00144664November 200419 February 2015Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIASystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting2 Years19 YearsBoth19Phase 3
43NCT00144612July 200419 February 2015Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JPSystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNot recruiting2 Years19 YearsBoth60Phase 3
44NCT00144599May 200419 February 2015Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIASystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab);Drug: placeboChugai PharmaceuticalNot recruiting2 Years19 YearsBoth56Phase 3
45JPRN-JapicCTI-05001723 April 2019Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)sJIAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion
Chugai Pharmaceutical Co., Ltd.219Phase 3

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