266. 家族性地中海熱 Familial mediterranean fever Clinical trials / Disease details


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_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT05190991
(ClinicalTrials.gov)
October 5, 20213/11/2021Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean FeverAn International Multicenter Open-label Clinical Study of the Safety and Efficacy of RPH-104 for Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of ColchicineFamilial Mediterranean Fever;FMFBiological: RPH-104R-Pharm International, LLCAtlant Clinical LLC;Center for Pharmaceutical Analytics LLC;Unimed Laboratories CJSC;Data Management 365 LLCRecruiting18 Years80 YearsAll60Phase 2Armenia;Georgia;Russian Federation
2NCT04478409
(ClinicalTrials.gov)
July 21, 202116/7/2020Characterization of a Functional Test for Mediterranean Family Fever Screening - 2Characterization of a Functional Test for Mediterranean Family Fever Screening - 2Familial Mediterranean Fever;MEFV Gene MutationBiological: one additional blood sample during a planned blood testHospices Civils de LyonNULLRecruiting4 YearsN/AAll160France
3NCT03563300
(ClinicalTrials.gov)
September 1, 201824/5/2018Gluten-related Disorders in Familial Mediterranean Fever PatientsGluten-related Disorders in Patients Affected With Familial Mediterranean FeverNot-celiac Wheat Sensitivity (NCWS);Familial Mediterranean Fever (FMF)Other: Wheat flour;Other: Placebo ComparatorUniversity of PalermoNULLCompleted18 Years65 YearsAll8N/AItaly
4JPRN-UMIN000032557
2018/09/0130/05/2018An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intoleranceAn open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance - An open-label continuation trial of tocilizumab for familial Mediterranean fever familial Mediterranean feverTocilizumabDepartment of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical SciencesNULLComplete: follow-up continuing12years-oldNot applicableMale and Female24Not selectedJapan
5NCT03446209
(ClinicalTrials.gov)
April 23, 201811/12/2017Tocilizumab for the Treatment of Familial Mediterranean FeverTocilizumab for the Treatment of Familial Mediterranean Fever - A Randomized, Doubleblind, Phase II Proof of Concept StudyFamilial Mediterranean FeverDrug: Tocilizumab Infusion RoAcemtra (EU);Drug: 0.9% physiological salineUniversity Hospital TuebingenNULLCompleted18 Years64 YearsAll30Phase 2Germany
6JPRN-UMIN000028010
2018/03/0107/07/2017Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean feverRandomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever - Clinical trial of Tocilizumab for colchicine-resistant familial Mediterranean fever familial Mediterranean feverTocilizumab
Placebo
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical SciencesNULLComplete: follow-up complete12years-oldNot applicableMale and Female24Not selectedJapan
7EUCTR2016-004505-13-DE
(EUCTR)
27/11/201721/08/2017Tocilizumab for the Treatment of Familial Mediterranean FeverTocilizumab for the Treatment of Familial Mediterranean Fever – A randomized, doubleblind, phase II proof of concept study-TOFFIFE - Tocilizumab for the Treatment of Familial Mediterranean Fever Adult patients with Familial Mediterranean Fever, who have active disease
MedDRA version: 20.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra® 20mg/ml Konzentrat
INN or Proposed INN: INN-Tocilizumab
Other descriptive name: TOCILIZUMAB
University Hospital TuebingenNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Germany
8NCT03210610
(ClinicalTrials.gov)
October 19, 201729/6/2017Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) PatientsMeasurement of Colchicine Levels in the Serum of FMF PatientsFMF;Colchicine Resistance;Colchicine ToxicityDiagnostic Test: colchicine level measurementSheba Medical CenterNULLUnknown status18 YearsN/AAll80Israel
9EUCTR2013-004291-35-NL
(EUCTR)
07/10/201424/07/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
10EUCTR2013-004291-35-GR
(EUCTR)
22/09/201422/09/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 17.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;Japan
11EUCTR2013-004291-35-HU
(EUCTR)
09/09/201425/06/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
12EUCTR2013-004291-35-IE
(EUCTR)
14/08/201410/04/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
13EUCTR2013-004291-35-BE
(EUCTR)
20/06/201427/05/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 18.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
14EUCTR2013-004291-35-DE
(EUCTR)
18/06/201414/04/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885, 150mg/1.0ml
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan
15NCT02175589
(ClinicalTrials.gov)
June 201424/6/2014Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene MutationControlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene MutationFamilial Mediterranean FeverOther: Colchicine CessationRambam Health Care CampusSchneider Children's HospitalEnrolling by invitation2 Years18 YearsBoth80Phase 2Israel
16EUCTR2013-004291-35-IT
(EUCTR)
16/05/201420/03/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farma SpANULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
17EUCTR2013-004291-35-ES
(EUCTR)
14/05/201404/04/2014Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversA randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)
MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;Classification code 10072010;Term: Hyper IgD syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan
18NCT02021084
(ClinicalTrials.gov)
December 201329/10/2013The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.Familial Mediterranean Fever (FMF )Dietary Supplement: probiotic;Dietary Supplement: PlaceboRambam Health Care CampusNULLWithdrawn5 Years18 YearsBoth0N/ANULL
19NCT01705756
(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
20NCT02602028
(ClinicalTrials.gov)
April 20115/11/2015The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMFThe Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized TrialFamilial Mediterranean FeverDrug: colchicineGulhane Military Medical AcademyNULLCompleted5 Years16 YearsBoth79Phase 4Turkey
21NCT01148797
(ClinicalTrials.gov)
December 201021/6/2010Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean FeverColchicine Resistant/Intolerant Familial Mediterranean FeverDrug: CanakinumabNovartis PharmaceuticalsNULLCompleted4 Years20 YearsBoth15Phase 2Israel
22NCT01075906
(ClinicalTrials.gov)
August 201024/2/2010Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) PatientsAn Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMFFamilial Mediterranean FeverDrug: colchicine sprinkle capsulesMutual Pharmaceutical Company, Inc.NULLCompleted2 Years65 YearsBoth75Phase 1United States;Armenia;Israel;Turkey
23NCT01088880
(ClinicalTrials.gov)
April 201016/3/2010Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean FeverAn Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean FeverFamilial Mediterranean FeverDrug: CanakinumabNovartis PharmaceuticalsNULLCompleted12 Years75 YearsBoth10Phase 2Turkey
24NCT00582907
(ClinicalTrials.gov)
August 200819/12/2007Rilonacept for Treatment of Familial Mediterranean Fever (FMF)Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)Familial Mediterranean FeverDrug: Rilonacept;Drug: PlaceboThe Cleveland ClinicNULLCompleted4 YearsN/AAll14Phase 2United States
25NCT00094900
(ClinicalTrials.gov)
October 200428/10/2004Interleukin-1 Trap to Treat Autoinflammatory DiseasesContinuation of a Pilot Open-Label Study of IL 1 Trap in Adult Subjects With Autoinflammatory Diseases: A Therapeutic Approach to Study PathogenesisInflammation;Familial Mediterranean Fever;Still's Disease, Adult-OnsetDrug: IL-1 TrapNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 YearsN/AAll11Phase 2United States
26EUCTR2017-001678-40-Outside-EU/EEA
(EUCTR)
15/05/2017An extension study of safety of canakinumab in Japanese patients with periodic fever syndromesAn extension study of safety of canakinumab in Japanese patients with periodic fever syndromes Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF
MedDRA version: 20.0;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: Ilaris
INN or Proposed INN: CANAKINUMAB
Novartis pharma AGNULLNAFemale: yes
Male: yes
4Phase 3Japan
27EUCTR2015-003522-13-Outside-EU/EEA
(EUCTR)
14/04/2016Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever Colchicine Resistant/Intolerant Familial Mediterranean Fever
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis PharmaceuticalsNULLNAFemale: yes
Male: yes
15Phase 2Israel
28EUCTR2015-003527-57-Outside-EU/EEA
(EUCTR)
14/04/2016Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean FeverAn Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Familial Mediterranean Fever
MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis PharmaceuticalsNULLNAFemale: yes
Male: yes
9Turkey