DDrare: Database of Drug Development for Rare Diseases

266. 家族性地中海熱　［臨床試験数：16，薬物数：14（DrugBank：6），標的遺伝子数：14，標的パスウェイ数：52］

Searched query = "Familial mediterranean fever"
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.

Drug = 0.9% physiological saline; Canakinumab; Colchicine; Colchicine sprinkle capsules; Il-1 trap; Ilaris; Inn-tocilizumab; Kineret; Probiotic; Rilonacept; Roactemra® 20mg/ml konzentrat; Tocilizumab; Tocilizumab infusion roacemtra (eu); Wheat

No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000032557	2018/09/01	5 November 2019	An open-label continuation trial of tocilizumab for familial Mediterranean fever (FMF) with colchicine ineffective or intolerance	An open-label continuation trial of tocilizumab for familial Mediterranean fever (FMF) with colchicine ineffective or intolerance - An open-label continuation trial of tocilizumab for familial Mediterranean fever	familial Mediterranean fever	Tocilizumab	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences		Recruiting	12years-old	76years-old	Male and Female	24	Not selected	Japan
2	NCT03563300	September 1, 2018	29 April 2019	Gluten-related Disorders in Familial Mediterranean Fever Patients	Gluten-related Disorders in Patients Affected With Familial Mediterranean Fever	Not-celiac Wheat Sensitivity (NCWS);Familial Mediterranean Fever (FMF)	Other: Wheat flour;Other: Placebo Comparator	University of Palermo		Not recruiting	18 Years	65 Years	All	8	N/A	Italy
3	NCT03446209	April 23, 2018	29 April 2019	Tocilizumab for the Treatment of Familial Mediterranean Fever	Tocilizumab for the Treatment of Familial Mediterranean Fever - A Randomized, Doubleblind, Phase II Proof of Concept Study	Familial Mediterranean Fever	Drug: 0.9% physiological saline;Drug: Tocilizumab Infusion RoAcemtra (EU)	University Hospital Tuebingen		Recruiting	18 Years	64 Years	All	30	Phase 2	Germany
4	JPRN-UMIN000028010	2018/03/01	22 July 2019	Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever	Randomized, 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 fever	Tocilizumab Placebo	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences		Not Recruiting	12years-old	Not applicable	Male and Female	24	Not selected	Japan
5	EUCTR2016-004505-13-DE	27/11/2017	30 April 2018	Tocilizumab for the Treatment of Familial Mediterranean Fever	Tocilizumab 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 CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 8- Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use	University Hospital Tuebingen		Authorised			Female: yes Male: yes	30	Phase 2	Germany
No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT03210610	October 19, 2017	11 June 2018	Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients	Measurement of Colchicine Levels in the Serum of FMF Patients	FMF;Colchicine Resistance;Colchicine Toxicity	Diagnostic Test: colchicine level measurement	Sheba Medical Center		Recruiting	18 Years	N/A	All	80	Phase 4	Israel
7	EUCTR2017-001678-40-Outside-EU/EEA		22 May 2017	An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes	An 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: CANAKINUMAB CAS Number: 914613-48-2 Current Sponsor code: ACZ885 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 4-	Novartis pharma AG		Not Available			Female: yes Male: yes	4	Phase 3	Japan
8	NCT02175589	June 2014	19 February 2015	Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation	Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation	Familial Mediterranean Fever	Other: Colchicine Cessation	Rambam Health Care Campus	Schneider Children's Hospital	Recruiting	2 Years	18 Years	Both	80	Phase 2	Israel
9	NCT02021084	December 2013	17 October 2016	The 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: Placebo	Rambam Health Care Campus		Not recruiting	5 Years	18 Years	Both	0	N/A
10	NCT01705756	November 2012	16 December 2017	Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever	A Randomized Placebo-Controlled Study of the Efficacy and Safety of Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever	Familial Mediterranean Fever	Drug: Kineret	Sheba Medical Center		Not recruiting	18 Years	65 Years	All	25	Phase 3	Israel
No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT02602028	April 2011	23 November 2015	The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF	The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized Trial	Familial Mediterranean Fever	Drug: colchicine	Gulhane Military Medical Academy		Not recruiting	5 Years	16 Years	Both	79	Phase 4	Turkey
12	NCT01148797	December 2010	28 November 2016	Evaluate 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	Drug: Canakinumab	Novartis Pharmaceuticals		Not recruiting	4 Years	20 Years	Both	15	Phase 2	Israel
13	NCT01075906	August 2010	19 February 2015	Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients	An Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMF	Familial Mediterranean Fever	Drug: colchicine sprinkle capsules	Mutual Pharmaceutical Company, Inc.		Not recruiting	2 Years	65 Years	Both	75	Phase 1	United States;Armenia;Israel;Turkey
14	NCT01088880	April 2010	19 February 2015	Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever	An 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	Drug: Canakinumab	Novartis Pharmaceuticals		Not recruiting	12 Years	75 Years	Both	10	Phase 2	Turkey
15	NCT00582907	August 2008	19 October 2017	Rilonacept for Treatment of Familial Mediterranean Fever (FMF)	Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)	Familial Mediterranean Fever	Drug: Rilonacept;Drug: Placebo	The Cleveland Clinic		Not recruiting	4 Years	N/A	All	14	Phase 2	United States
No.	TrialID	Date_ enrollement	Last_Refreshed_ on	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT00094900	October 2004	19 October 2017	Interleukin-1 Trap to Treat Autoinflammatory Diseases	Continuation of a Pilot Open-Label Study of IL 1 Trap in Adult Subjects With Autoinflammatory Diseases: A Therapeutic Approach to Study Pathogenesis	Inflammation;Familial Mediterranean Fever;Still's Disease, Adult-Onset	Drug: IL-1 Trap	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)		Not recruiting	18 Years	N/A	All	11	Phase 2	United States

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