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 | NCT05448391 (ClinicalTrials.gov) | September 13, 2022 | 1/7/2022 | A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF) | An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever | Familial Mediterranean Fever | Drug: RIST4721 | Aristea Therapeutics, Inc. | NULL | Withdrawn | 18 Years | 74 Years | All | 0 | Phase 2 | Israel;Turkey |
| 2 | 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 |
| 3 | 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 |
| 4 | NCT04478409 (ClinicalTrials.gov) | July 21, 2021 | 16/7/2020 | Characterization of a Functional Test for Mediterranean Family Fever Screening - 2 | Characterization of a Functional Test for Mediterranean Family Fever Screening - 2 | Familial Mediterranean Fever;MEFV Gene Mutation | Biological: one additional blood sample during a planned blood test | Hospices Civils de Lyon | NULL | Recruiting | 4 Years | N/A | All | 160 | France | |
| 5 | 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 |
| 6 | 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 |
| 7 | NCT03446209 (ClinicalTrials.gov) | April 23, 2018 | 11/12/2017 | 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: Tocilizumab Infusion RoAcemtra (EU);Drug: 0.9% physiological saline | University Hospital Tuebingen | NULL | Completed | 18 Years | 64 Years | All | 30 | Phase 2 | Germany |
| 8 | 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 |
| 9 | EUCTR2016-004505-13-DE (EUCTR) | 27/11/2017 | 21/08/2017 | 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 INN or Proposed INN: INN-Tocilizumab Other descriptive name: TOCILIZUMAB | University Hospital Tuebingen | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Germany | ||
| 10 | EUCTR2013-004291-35-NL (EUCTR) | 07/10/2014 | 24/07/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan | ||
| 11 | EUCTR2013-004291-35-GR (EUCTR) | 22/09/2014 | 22/09/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 12 | EUCTR2013-004291-35-HU (EUCTR) | 09/09/2014 | 25/06/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan | ||
| 13 | EUCTR2013-004291-35-IE (EUCTR) | 14/08/2014 | 10/04/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan | ||
| 14 | EUCTR2013-004291-35-BE (EUCTR) | 20/06/2014 | 27/05/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan | ||
| 15 | EUCTR2013-004291-35-DE (EUCTR) | 18/06/2014 | 14/04/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Belgium;Netherlands;Germany;Japan | ||
| 16 | EUCTR2013-004291-35-IT (EUCTR) | 16/05/2014 | 20/03/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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 SpA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan | ||
| 17 | EUCTR2013-004291-35-ES (EUCTR) | 14/05/2014 | 04/04/2014 | Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Denmark;Netherlands;Germany;Japan | ||
| 18 | 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 | |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | NCT00582907 (ClinicalTrials.gov) | August 2008 | 19/12/2007 | 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 | NULL | Completed | 4 Years | N/A | All | 14 | Phase 2 | United States |
| 25 | NCT00094900 (ClinicalTrials.gov) | October 2004 | 28/10/2004 | 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) | NULL | Completed | 18 Years | N/A | All | 11 | Phase 2 | United States |
| 26 | 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 | ||||
| 27 | EUCTR2017-001678-40-Outside-EU/EEA (EUCTR) | 15/05/2017 | 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 INN or Proposed INN: CANAKINUMAB | Novartis pharma AG | NULL | NA | Female: yes Male: yes | 4 | Phase 3 | Japan | |||
| 28 | 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 |