Kineret ( DrugBank: - )


9 diseases
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス1
41巨細胞性動脈炎1
46悪性関節リウマチ5
49全身性エリテマトーデス1
65原発性免疫不全症候群1
106クリオピリン関連周期熱症候群2
107若年性特発性関節炎3
266家族性地中海熱1
299嚢胞性線維症1

28. 全身性アミロイドーシス


臨床試験数 : 261 薬物数 : 276 - (DrugBank : 81) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 178
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-001927-20-IT
(EUCTR)
01/07/200615/06/2007Treatment with Anakinra in TRAPS - NDTreatment with Anakinra in TRAPS - ND TRAPS
MedDRA version: 9.1;Level: LLT;Classification code 10016202;Term: Familial amyloidosis
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
INN or Proposed INN: Anakinra
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Italy

41. 巨細胞性動脈炎


臨床試験数 : 128 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 124
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-005804-27-FR
(EUCTR)
04/06/201629/01/2016GiAnT (Giant cell arteritis and Anakinra Trial)Essai randomisé, contrôlé, en double aveugle, de l'anakinra contre placebo, en adjonction à la corticothérapie dans l'artérite à cellules géantes. - GiAnT Patients atteints d’artérite à cellules géantes (ou maladie de Horton)
MedDRA version: 18.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: KINERETCHU CAENNULLNot RecruitingFemale: yes
Male: yes
70Phase 3France

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-005370-62-IT
(EUCTR)
18/02/201311/01/2013clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes.No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study. rheumatoid arthritis and type 2 diabetes mellitus as comorbidity.
MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859
MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
INN or Proposed INN: ANAKINRA
OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILANULLNot RecruitingFemale: yes
Male: yes
200Phase 4Italy
2NCT02915094
(ClinicalTrials.gov)
October 201223/9/2016Kineret in the Treatment of Rheumatoid ArthritisKineret in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: AnakinraSwedish Orphan BiovitrumNULLCompleted18 YearsN/AAll30N/AGermany
3NCT00117091
(ClinicalTrials.gov)
September 200430/6/2005Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Anakinra (Kineret®)AmgenNULLCompleted18 YearsN/ABothPhase 3NULL
4NCT00121043
(ClinicalTrials.gov)
October 200230/6/2005Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported QuestionnaireAn Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported QuestionnaireRheumatoid ArthritisDevice: SimpleJectTM;Drug: Kineret® (Anakinra)AmgenNULLCompleted18 YearsN/ABothPhase 4NULL
5NCT00121056
(ClinicalTrials.gov)
September 200230/6/2005REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal EvaluationsRegistry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)Rheumatoid ArthritisDrug: Enbrel®;Drug: Kineret®AmgenNULLCompleted18 YearsN/ABothN/ANULL

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-005392-16-ES
(EUCTR)
23/05/201217/04/2012Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosusStudy to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients - ANAKINRA AND LUPUS ARTHRITIS Systemic lupus erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KINERET
Product Name: KINERET
Product Code: KINERET
INN or Proposed INN: ANAKINRA
Dr Josep Ordi RosNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain

65. 原発性免疫不全症候群


臨床試験数 : 482 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04136028
(ClinicalTrials.gov)
September 25, 201521/10/2019IL-1 Receptor Inhibitor for Granulomatous Complications in Patients With Chronic Granulomatous DiseaseA Retrospective Analysis of Efficacy and Safety of Interleukin-1 Receptor Inhibitor for the Treatment of Granulomatous Complications in Patients With Chronic Granulomatous DiseaseChronic Granulomatous DiseaseDrug: KineretFederal Research Institute of Pediatric Hematology, Oncology and ImmunologyNULLCompletedN/A18 YearsAll13Early Phase 1Russian Federation

106. クリオピリン関連周期熱症候群


臨床試験数 : 42 薬物数 : 24 - (DrugBank : 4) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 48
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00069329
(ClinicalTrials.gov)
September 200322/9/2003Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory DiseaseA Long-Term Outcome Study With the IL-1 Receptor Antagonist Anakinra/Kineret in Patients With Neonatal Onset Multisystem Inflammatory Disease (NOMID/CINCA Syndrome) A Therapeutic Approach to Study the Pathogenesis of This DiseaseNervous System Malformations;Arthropathy, Neurogenic;Urticaria;PapilledemaDrug: anakinraNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLTerminatedN/AN/AAll43Phase 1/Phase 2United States
2EUCTR2013-000300-42-Outside-EU/EEA
(EUCTR)
18/01/2013A long-term study with the IL-1 receptor blocker anakinra/kineret® in patients with neonatal onset multisystem inflammatory disease (NOMID/CINCA syndrome)A long-term outcome study with the IL-1 receptor antagonist Anakinra/Kineret® in patients with Neonatal onset multisystem inflammatory disease (Nomid/Cinca syndrome) neonatal onset multisystem inflammatory disease (NOMID/CINCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: KineretNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLNAFemale: yes
Male: yes
50United States

107. 若年性特発性関節炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03932344
(ClinicalTrials.gov)
April 10, 201916/4/2019Long-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 BiovitrumNULLCompletedN/AN/AAll306Italy
2EUCTR2015-004393-16-NL
(EUCTR)
04/10/201608/07/2016Biomarker-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 JIA systemic Juvenile Idiopathic Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: kineret® or anakinra
Product Name: anakinra / kineret
Product Code: not applicable
INN or Proposed INN: ANAKINRA
Other descriptive name: rIL-1RA
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
3EUCTR2005-004008-36-IT
(EUCTR)
27/10/200530/01/2012Efficacy 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 arthritis CINCA/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
INN or Proposed INN: Anakinra
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Italy

266. 家族性地中海熱


臨床試験数 : 28 薬物数 : 24 - (DrugBank : 6) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 59
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01705756
(ClinicalTrials.gov)
November 201227/9/2012Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean FeverA Randomized Placebo-Controlled Study of the Efficacy and Safety of Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean FeverFamilial Mediterranean FeverDrug: KineretSheba Medical CenterNULLCompleted18 Years65 YearsAll25Phase 3Israel

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004786-80-DE
(EUCTR)
30/06/2017Tolerability and Efficacy of Anakinra in patients with cystic fibrosis.A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutanous administration of anakinra in patients with cystic fibrosis. - ANAKIN Cystic fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10028141;Term: Mucoviscidosis;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kineret
INN or Proposed INN: ANAKINRA
Ruprecht-Karls-University Heidelberg, Medical FacultyNULLNA Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany