266. 家族性地中海熱 Familial mediterranean fever Clinical trials / Disease details
臨床試験数 : 28 / 薬物数 : 22 - (DrugBank : 5) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 59
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05418686 (ClinicalTrials.gov) | July 2022 | 10/6/2022 | Study of Colchicine Resistance in Familial Mediterranean Fever | Study Of Colchicine Resistance In Familial Mediterranean Fever | Mediterranean Fever;Colchicine Resistance | Biological: Capillary colchicine dosage in colchicine-resistant Familial Mediterranean Fever patients. | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 12 Years | N/A | All | 30 | N/A | France |
| 2 | NCT05190991 (ClinicalTrials.gov) | October 5, 2021 | 3/11/2021 | Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever | An 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 Colchicine | Familial Mediterranean Fever;FMF | Biological: RPH-104 | R-Pharm International, LLC | Atlant Clinical LLC;Center for Pharmaceutical Analytics LLC;Unimed Laboratories CJSC;Data Management 365 | Recruiting | 18 Years | 80 Years | All | 60 | Phase 2 | Armenia;Georgia;Russian Federation |
| 3 | NCT05092776 (ClinicalTrials.gov) | April 29, 2021 | 9/9/2021 | Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine | International, Multicenter, Double Blind, Placebo-controlled, Randomized Clinical Study of Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine | Familial Mediterranean Fever;FMF | Biological: RPH-104;Drug: Placebo | R-Pharm International, LLC | Data Management 365;Atlant Clinical LLC;R-Pharm;Center of Pharmaceutical Analytics LLC;Unimed Laboratories CJSC | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Armenia;Georgia;Russian Federation |
| 4 | JPRN-UMIN000032557 | 2018/09/01 | 30/05/2018 | An 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 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 | NULL | Complete: follow-up complete | 12years-old | Not applicable | Male and Female | 24 | Not selected | Japan |
| 5 | JPRN-UMIN000028010 | 2018/03/01 | 07/07/2017 | 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 | NULL | Complete: follow-up complete | 12years-old | Not applicable | Male and Female | 24 | Not selected | Japan |
| 6 | NCT02021084 (ClinicalTrials.gov) | December 2013 | 29/10/2013 | 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 | NULL | Withdrawn | 5 Years | 18 Years | Both | 0 | N/A | NULL | |
| 7 | NCT01705756 (ClinicalTrials.gov) | November 2012 | 27/9/2012 | 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 | NULL | Completed | 18 Years | 65 Years | All | 25 | Phase 3 | Israel |
| 8 | NCT02602028 (ClinicalTrials.gov) | April 2011 | 5/11/2015 | 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 | NULL | Completed | 5 Years | 16 Years | Both | 79 | Phase 4 | Turkey |
| 9 | NCT01148797 (ClinicalTrials.gov) | December 2010 | 21/6/2010 | 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 | NULL | Completed | 4 Years | 20 Years | Both | 15 | Phase 2 | Israel |
| 10 | NCT01075906 (ClinicalTrials.gov) | August 2010 | 24/2/2010 | 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. | NULL | Completed | 2 Years | 65 Years | Both | 75 | Phase 1 | United States;Armenia;Israel;Turkey |
| 11 | NCT01088880 (ClinicalTrials.gov) | April 2010 | 16/3/2010 | 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 | NULL | Completed | 12 Years | 75 Years | Both | 10 | Phase 2 | Turkey |
| 12 | EUCTR2015-003527-57-Outside-EU/EEA (EUCTR) | 14/04/2016 | 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 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 Pharmaceuticals | NULL | NA | Female: yes Male: yes | 9 | Turkey | ||||
| 13 | EUCTR2015-003522-13-Outside-EU/EEA (EUCTR) | 14/04/2016 | 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 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 Pharmaceuticals | NULL | NA | Female: yes Male: yes | 15 | Phase 2 | Israel |