Canakinumab ( DrugBank: Canakinumab )


10 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ19
56ベーチェット病2
84サルコイドーシス4
106クリオピリン関連周期熱症候群27
107若年性特発性関節炎61
108TNF受容体関連周期性症候群4
113筋ジストロフィー1
266家族性地中海熱13
267高IgD症候群10
269化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群1

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 : 185 - 標的パスウェイ数 : 223
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05080218
(ClinicalTrials.gov)
October 20216/10/2021COVID-19 VaccinE Response in Rheumatology PatientsThe SARS-CoV-2 Vaccine Response and Safety in Rheumatology Patients and the Influence of Temporary Interruptions in Immunomodulatory TherapyRheumatoid Arthritis;Psoriatic Arthritis;SpondylarthritisDrug: Upadacitinib;Drug: Abatacept;Drug: Secukinumab;Drug: Tofacitinib;Drug: TNF Inhibitor;Drug: Canakinumab InjectionJeffrey CurtisUniversity of Alabama at Birmingham;University of Nebraska;University of Pennsylvania;AbbVie;Bristol-Myers Squibb;Novartis;Eli Lilly and Company;PfizerNot yet recruiting18 Years85 YearsAll1000Phase 4United States
2EUCTR2008-005320-81-ES
(EUCTR)
18/02/200920/01/2009Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2 Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Belgium;Spain;Austria;Germany
3EUCTR2008-005320-81-BE
(EUCTR)
16/02/200920/02/2009A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class
Novartis Pharma Services AGNovartis Pharma BelgiumNot RecruitingFemale: yes
Male: yes
Spain;Belgium;Austria;Germany
4EUCTR2008-005320-81-DE
(EUCTR)
06/02/200917/11/2008A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to interleukin-1beta of the IgG1-Kappa-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
213Germany;Spain;Austria
5EUCTR2008-005320-81-AT
(EUCTR)
21/10/200822/09/2008A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain;Austria
6EUCTR2007-001665-15-IT
(EUCTR)
10/12/200705/10/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - NDA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073
Product Name: Canakinumab
Product Code: ACZ885
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
179Phase 2Germany;Netherlands;Spain;Italy
7EUCTR2007-000491-16-AT
(EUCTR)
06/12/200705/04/2007A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not availableA 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
260Germany;Spain;Austria
8EUCTR2007-001665-15-NL
(EUCTR)
09/11/200717/10/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritisA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
179Phase 2Germany;Netherlands;Spain;Italy
9EUCTR2007-001665-15-DE
(EUCTR)
16/10/200730/07/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritisA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
179Phase 2Germany;Netherlands;Spain;Italy
10EUCTR2007-001665-15-ES
(EUCTR)
14/09/200727/06/2007Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide.Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide. Artritis Reumatoide
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Farmaceutica S.A.NULLNot RecruitingFemale: yes
Male: yes
179Belgium;Spain;Netherlands;Germany;Italy
11EUCTR2007-001665-15-BE
(EUCTR)
05/09/200702/08/2007A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritisA 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
179Phase 2Spain;Belgium;Netherlands;Germany;Italy
12EUCTR2006-004666-14-DE
(EUCTR)
17/07/200702/04/2007An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not availableAn exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
32Germany
13EUCTR2007-000491-16-BE
(EUCTR)
22/06/200704/05/2007A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not availableA 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
Spain;Belgium;Austria;Germany
14EUCTR2007-000491-16-DE
(EUCTR)
08/06/200722/03/2007A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not availableA 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain;Austria
15EUCTR2006-004666-14-BE
(EUCTR)
04/06/200729/03/2007An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not availableAn exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
32Belgium;Germany
16EUCTR2007-000491-16-ES
(EUCTR)
30/04/200705/03/2007Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not availableEstudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available Artritis Reumatoide
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
Belgium;Spain;Austria;Germany
17EUCTR2006-004669-32-ES
(EUCTR)
09/04/200706/02/2007Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not availableEstudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available Artritis reumatoide establecida
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
80Spain
18NCT00487825
(ClinicalTrials.gov)
March 200718/6/2007Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid ArthritisA 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX)NovartisNULLCompleted18 Years75 YearsAll78Phase 2United States;Belgium;Germany;Italy;Netherlands;Spain
19NCT00424346
(ClinicalTrials.gov)
November 200617/1/2007Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid ArthritisA 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week ExtensionsRheumatoid ArthritisDrug: Canakinumab;Drug: PlaceboNovartisNULLCompleted18 YearsN/AAll274Phase 2United States;Austria;Belgium;Canada;Germany;Spain;Finland

56. ベーチェット病


臨床試験数 : 76 薬物数 : 110 - (DrugBank : 32) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02756650
(ClinicalTrials.gov)
June 23, 201631/3/20161 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular InvolvementAn Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular InvolvementBehcet DiseaseDrug: CanakinumabNovartis PharmaceuticalsNULLCompleted18 Years60 YearsAll8Phase 2Turkey
2EUCTR2010-024152-29-DE
(EUCTR)
02/09/201121/06/2011An open-label study to evaluate efficacy and tolerability of Canakinumab in patients with Behçet Disease who do not respond to standard treatment (Eine offene Studie zur Wirksamkeit und Verträglichkeit von Canakinumab bei Patienten mit Morbus Behçet, die auf die übliche Behandlung nicht ansprechen)Canakinumab for Behçet`s Disease Resistant to Standard Treatment(CanBeDisT) - CanBeDisT Behçet`s Disease
MedDRA version: 14.0;Level: PT;Classification code 10004213;Term: Behcet's syndrome;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Ilaris
Product Name: Ilaris
INN or Proposed INN: CANAKINUMAB
University Hospital of TübingenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Germany

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 227 - (DrugBank : 81) / 標的遺伝子数 : 82 - 標的パスウェイ数 : 167
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02888080
(ClinicalTrials.gov)
December 19, 201616/8/2016Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary SarcoidosisA Multiple-dose, Subject and Investigator Blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885(Canakinumab) in Patients With Pulmonary SarcoidosisPulmonary SarcoidosisDrug: ACZ885;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years80 YearsAll40Phase 2United States;Germany;Netherlands
2EUCTR2016-001255-49-NL
(EUCTR)
18/10/201620/07/2016Study of efficacy, safety and tolerability of ACZ885 (Canakinumab) in patients with pulmonary sarcoidosisA multiple-dose, subject- and investigator-blinded, placebo-controlled, parallel design study to assess the efficacy, safety, and tolerability of ACZ885 (canakinumab) in patients with pulmonary sarcoidosis Pulmonary sarcoidosis
MedDRA version: 20.0;Level: PT;Classification code 10037430;Term: Pulmonary sarcoidosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ILARIS
Product Code: ACZ885
INN or Proposed INN: canakinumab
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 2United States;Germany;Netherlands
3EUCTR2016-001255-49-DE
(EUCTR)
15/08/201611/07/2016Study of efficacy, safety and tolerability of ACZ885 (Canakinumab) in patients with pulmonary sarcoidosisA multiple-dose, subject- and investigator-blinded, placebo-controlled, parallel design study to assess the efficacy, safety, and tolerability of ACZ885 (canakinumab) in patients with pulmonary sarcoidosis Pulmonary sarcoidosis
MedDRA version: 20.0;Level: PT;Classification code 10037430;Term: Pulmonary sarcoidosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ILARIS
Product Code: ACZ885
INN or Proposed INN: canakinumab
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
38 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Netherlands;Germany
4EUCTR2013-005333-21-NL
(EUCTR)
30/06/201508/01/2015Study of efficacy, safety and tolerability of ACZ885 (Canikumab) in patients with pulmonary sarcoidosisA multiple-dose, double-blind, placebo-controlled, parallel study to assess the efficacy, safety and tolerability of ACZ885 (Canikumab) in patients with pulmonary sarcoidosis Pulmonary sarcoidosis
MedDRA version: 17.1;Level: PT;Classification code 10037430;Term: Pulmonary sarcoidosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
90United States;Netherlands

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
1EUCTR2014-001393-34-BE
(EUCTR)
14/04/201403/04/2014Ilaris® (canakinumab) efficacy and safety in CAPS patients without confirmed mutation on exon 3 of gene CIAS1 and young (<2yrs) CAPS patients with severe neurological (CINCA) phenotype.Ilaris® (canakinumab) efficacy and safety in CAPS patients without confirmed mutation on exon 3 of gene CIAS1 and young (<2yrs) CAPS patients with severe neurological (CINCA) phenotype. Cryopyrin-Associated Periodic Syndromes
MedDRA version: 17.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic 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: Ilaris
UZ LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
2EUCTR2011-005154-57-GB
(EUCTR)
09/03/201313/11/2013A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 17.0;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Canada;Belgium;Spain;Israel;Germany;United Kingdom
3EUCTR2011-005154-57-FR
(EUCTR)
08/02/201319/01/2012A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
16France;Canada;Belgium;Spain;Israel;Germany;United Kingdom
4EUCTR2009-016859-22-FR
(EUCTR)
04/02/201314/06/2010A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS).A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Ireland;Germany;United Kingdom
5EUCTR2011-005154-57-DE
(EUCTR)
04/06/201201/02/2012A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
16France;Canada;Spain;Belgium;Israel;Germany;United Kingdom
6EUCTR2011-005154-57-ES
(EUCTR)
20/03/201227/01/2012An extension study to check how safe, beneficial and tolerable the drugcanakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerabilityof canakinumab and the efficacy and safety of childhood vaccinations inpatients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
16France;Canada;Belgium;Spain;Israel;Germany;United Kingdom
7NCT01576367
(ClinicalTrials.gov)
January 16, 201217/2/2012Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseAn Open-label Extension Study to Assess Efficacy, Safety and Tolerability of Canakinumab and the Efficacy and Safety of Childhood Vaccinations in Patients With Cryopyrin Associated Periodic Syndromes (CAPS)Cryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseBiological: ACZ885Novartis PharmaceuticalsNULLCompleted1 Year4 YearsAll17Phase 3Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom
8EUCTR2011-005154-57-BE
(EUCTR)
03/01/201206/12/2011A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.0;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
16Phase 3France;Canada;Spain;Belgium;Israel;Germany;United Kingdom
9EUCTR2009-016859-22-DE
(EUCTR)
11/11/201022/06/2010A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). - D2307A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome
Trade Name: ILARIS
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
15France;Belgium;Spain;Germany;United Kingdom
10NCT01302860
(ClinicalTrials.gov)
November 201022/2/2011Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseA One-year Open-label, Multicenter Trial to Assess Efficacy, Safety and Tolerability of Canakinumab (ACZ885) and the Efficacy and Safety of Childhood Vaccinations in Patients Aged 4 Years or Younger With Cryopyrin Associated Periodic Syndromes (CAPS)Cryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseDrug: ACZ885Novartis PharmaceuticalsNULLCompleted1 Month60 MonthsAll17Phase 3Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom
11EUCTR2009-016859-22-GB
(EUCTR)
15/10/201001/07/2010A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS).A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 17.0;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Ireland;Germany;United Kingdom
12EUCTR2009-016859-22-ES
(EUCTR)
27/08/201030/06/2010Ensayo multicéntrico abierto de un año de seguimiento para evaluar la eficacia, seguridad y tolerabilidad de canakinumab (ACZ885) y la eficacia y seguridad de las vacunas pediátricas en pacientes de 4 años de edad o menores con Síndromes Periódicos Asociados a Criopirina (CAPS)Ensayo multicéntrico abierto de un año de seguimiento para evaluar la eficacia, seguridad y tolerabilidad de canakinumab (ACZ885) y la eficacia y seguridad de las vacunas pediátricas en pacientes de 4 años de edad o menores con Síndromes Periódicos Asociados a Criopirina (CAPS) Síndromes Periódicos Asociados a Criopirina (CAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome
Product Name: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Other descriptive name: CANAKINUMAB
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
15France;Belgium;Spain;Germany;United Kingdom
13EUCTR2009-016859-22-BE
(EUCTR)
12/08/201014/07/2010A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). - D2307A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Belgium;Germany;United Kingdom
14NCT01105507
(ClinicalTrials.gov)
August 201025/3/2010The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in CanadaAn Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in CanadaCryopyrin Associated Periodic SyndromeDrug: canakinumab (company code: ACZ885D)Novartis PharmaceuticalsNULLCompleted4 YearsN/AAll4Phase 3Canada
15EUCTR2007-004367-22-BE
(EUCTR)
16/10/200921/08/2009An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
80France;Spain;Belgium;Germany;Italy;United Kingdom
16NCT00991146
(ClinicalTrials.gov)
October 20096/10/2009Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension PhaseAn Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1ß Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in JapanCryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseDrug: canakinumabNovartis PharmaceuticalsNULLCompleted2 YearsN/AAll19Phase 3Japan
17NCT00770601
(ClinicalTrials.gov)
January 26, 20099/10/2008Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory DiseaseA Multi-Center, Open Label, 24-Month Treatment Study to Establish the Safety, Tolerability, Efficacy, Pharmacokinetics of Canakinumab (Anti-IL-1 Beta Antibody) in Patients With NOMID / CINCA SyndromeNOMID;CINCA SyndromeDrug: CanakinumabNovartis PharmaceuticalsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Terminated2 Years25 YearsAll7Phase 3United States
18EUCTR2007-004367-22-FR
(EUCTR)
18/06/200803/04/2008An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease. - D2306An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease. - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
80France;Belgium;Spain;Germany;Italy;United Kingdom
19EUCTR2007-004367-22-DE
(EUCTR)
02/06/200813/03/2008An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
80United Kingdom;Germany;France;Spain;Italy
20EUCTR2007-004367-22-GB
(EUCTR)
01/05/200807/03/2008 An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306 An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306 The following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Germany;Italy;United Kingdom
21NCT00685373
(ClinicalTrials.gov)
May 200827/5/2008Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseAn Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1ß Monoclonal Antibody) Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseCryopyrin-Associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseDrug: Canakinumab (ACZ885)NovartisNULLCompleted3 YearsN/AAll166Phase 3United States;Belgium;France;Germany;India;Italy;Spain;Turkey;United Kingdom
22EUCTR2009-016859-22-Outside-EU/EEA
(EUCTR)
09/03/2012?A study to check how safe, beneficial and tolerable the drugcanakinumab, along with childhood vaccines, is for patients withCryopyrin Associated Periodic Syndromes (CAPS).A one-year open-label, multicenter trial to assess efficacy, safety andtolerability of canakinumab (ACZ885) and the efficacy and safety ofchildhood vaccinations in patients aged 4 years or younger withCryopyrin Associated Periodic Syndromes (CAPS). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
15Canada;Israel;Switzerland
23EUCTR2015-003490-15-Outside-EU/EEA
(EUCTR)
14/04/2016Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension PhaseAn Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1ß Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in Japan Cryopyrin-associated Periodic SyndromesFamilial Cold Autoinflammatory SyndromeMuckle-Wells SyndromeNeonatal Onset Multisystem Inflammatory Disease
MedDRA version: 19.0;Level: PT;Classification code 10064570;Term: Familial cold autoinflammatory syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10064574;Term: NOMID;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;Classification code 10064569;Term: Muckle-Wells 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 PharmaceuticalsNULLNAFemale: yes
Male: yes
20Japan
24EUCTR2009-016859-22-IE
(EUCTR)
07/03/2013 ?A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with Crypoyrin Associated Periodic Syndromes (CAPS). A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Canada;Belgium;Spain;Ireland;Israel;Germany;United Kingdom;Switzerland
25EUCTR2007-004367-22-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drugcanakinumab is for patients with Crypoyrin Associated Periodic Syndromes (CAPS).An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
166India;Turkey;United States
26EUCTR2008-001429-32-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drugcanakinumab is for patients with NOMID / CINCA syndromeA multi-center, open label, 24-month treatment study to establish the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of canakinumab (anti-IL-1 beta antibody) in patients with NOMID / CINCA syndrome Neonatal onset multisystem inflammatory disease (abbreviated NOMID, also known as chronic infantile neurologic cutaneous and articular syndrome or CINCA)
MedDRA version: 14.1;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
7United States
27EUCTR2015-003491-69-Outside-EU/EEA
(EUCTR)
14/04/2016The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in CanadaAn Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada Cryopyrin Associated Periodic Syndrome
MedDRA version: 19.0;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis PharmaceuticalsNULLNAFemale: yes
Male: no
4Canada

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
1EUCTR2018-004284-30-DE
(EUCTR)
13/02/202029/07/2019Repsonse to Treatment with Canakinumab without steroids early after diagnosis of systemic onset juvenile idiopathic arthritis / juvenile Still’s diseaseEffectiveness of Canakinumab for first line steroid free treatment in systemic onset juvenile idiopathic arthritis / juvenile Still’s disease - CANAKINUMAB FIRST systemic juvenile idiopathic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ilaris
Product Name: Ilaris
Asklepios Klink Sankt AugustinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Germany
2NCT02396212
(ClinicalTrials.gov)
May 7, 201525/2/2015Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIAAn Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisBiological: CanakinumabNovartis PharmaceuticalsNULLCompleted2 Years19 YearsAll19Phase 3Japan
3JPRN-JapicCTI-152865
01/4/2015Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIAAn Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) Systemic Juvenile Idiopathic ArthritisIntervention name : ACZ885
INN of the intervention : Canakinumab
Dosage And administration of the intervention : 4mg/kg every 4 weeks
Control intervention name : null
Novartis Pharma K.K.NULL219BOTH20Phase 3NULL
4EUCTR2013-004867-29-NL
(EUCTR)
23/12/201423/09/2014Study of efficacy and safety of dose reduction or dose interval prolongation of canakinumab in patients with SJIAAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885G2306 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 19.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
5EUCTR2013-004867-29-DE
(EUCTR)
28/11/201425/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
6NCT02296424
(ClinicalTrials.gov)
November 17, 201410/10/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic Arthritis (SJIA)Drug: ACZ885 150 mg (Canakinumab)Novartis PharmaceuticalsNULLCompleted2 Years20 YearsAll182Phase 3United States;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Turkey;Argentina;Hong Kong;Mexico
7EUCTR2013-004867-29-BE
(EUCTR)
07/11/201429/09/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
8EUCTR2013-004867-29-HU
(EUCTR)
04/11/201425/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
9NCT02334748
(ClinicalTrials.gov)
November 3, 201423/12/2014A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 StudiesA French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)Systemic Juvenile Idiopathic Arthritis;Hereditary Periodic FeversDrug: canakinumabNovartis PharmaceuticalsNULLCompleted5 Years20 YearsAll31Phase 3France
10EUCTR2013-004867-29-ES
(EUCTR)
20/10/201406/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Ilaris
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
11EUCTR2013-004867-29-IT
(EUCTR)
03/10/201426/08/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
NOVARTIS FARMA S.p.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
12EUCTR2014-002872-95-FR
(EUCTR)
15/09/201418/06/2015A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1A French open-label extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who participated in the international phase III study CACZ885G2301E1 - CACZ885GFR01 Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations
MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma S.A.SNULLNot RecruitingFemale: yes
Male: yes
15Phase 4France
13EUCTR2013-004867-29-SE
(EUCTR)
10/09/201425/07/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
14EUCTR2013-004867-29-AT
(EUCTR)
04/09/201431/07/2014ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumabß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis(SJIA)
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 3;Phase 4United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
15EUCTR2012-003054-92-CZ
(EUCTR)
18/04/201318/12/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;Sweden
16EUCTR2012-003054-92-ES
(EUCTR)
28/01/201321/12/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ?-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
220United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden
17EUCTR2012-003054-92-AT
(EUCTR)
24/01/201311/12/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: Ilaris
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Trade Name: ILARIS
Product Name: Ilaris
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
239United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;Sweden
18NCT01676948
(ClinicalTrials.gov)
January 201329/8/2012An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisDrug: ACZ885;Drug: CanakinumabNovartis PharmaceuticalsPRINTO/PRCSGWithdrawn2 Years20 YearsBoth0Phase 3Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
19EUCTR2008-005476-27-GR
(EUCTR)
15/06/201017/12/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
20EUCTR2008-008008-42-GR
(EUCTR)
15/06/201004/12/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
21EUCTR2008-005479-82-GR
(EUCTR)
20/04/201004/12/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
22EUCTR2008-005476-27-GB
(EUCTR)
08/03/201011/09/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
23EUCTR2008-008008-42-AT
(EUCTR)
28/01/201030/12/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
304United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden
24EUCTR2008-005479-82-AT
(EUCTR)
17/12/200902/12/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
25EUCTR2008-005479-82-GB
(EUCTR)
16/12/200911/09/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
26EUCTR2008-008008-42-GB
(EUCTR)
16/12/200911/09/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever(Cohort 2 (treatment naive patients) only applicable in countries where approved) - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
304United States;Greece;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Netherlands;Norway;Germany;Sweden
27EUCTR2008-008008-42-DE
(EUCTR)
24/11/200917/04/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Denmark;Peru;Netherlands;Germany;Norway;Sweden
28EUCTR2008-005476-27-DE
(EUCTR)
24/11/200917/04/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
29EUCTR2008-005479-82-DE
(EUCTR)
24/11/200917/04/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
30EUCTR2008-008008-42-DK
(EUCTR)
10/11/200930/09/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88Hungary;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden
31EUCTR2008-008008-42-NL
(EUCTR)
05/11/200925/05/2009research with children with severe reumaAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Germany;Netherlands;Sweden
32EUCTR2008-005476-27-DK
(EUCTR)
28/10/200928/09/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Sweden
33EUCTR2008-005479-82-DK
(EUCTR)
28/10/200930/09/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden
34NCT00891046
(ClinicalTrials.gov)
September 200929/4/2009An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without FeverSystemic Juvenile Idiopathic ArthritisDrug: CanakinumabNovartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompleted2 Years19 YearsAll270Phase 3United States;Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Peru;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;Denmark;Norway;South Africa
35EUCTR2008-005479-82-IT
(EUCTR)
20/07/200905/08/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: ILARIS
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
36EUCTR2008-005479-82-SE
(EUCTR)
16/07/200916/06/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
37EUCTR2008-008008-42-SE
(EUCTR)
16/07/200916/06/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations, who participated in studies CACZ885G2301 and CACZ885G2305; and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever. - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
285United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Swaziland;Canada;Argentina;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden
38EUCTR2008-005476-27-SE
(EUCTR)
16/07/200918/06/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
39NCT00889863
(ClinicalTrials.gov)
July 200921/4/2009Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic ManifestationsSystemic Juvenile Idiopathic Arthritis With Active FlareDrug: canakinumab;Drug: placeboNovartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompleted2 Years19 YearsAll177Phase 3United States;Argentina;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Peru;Poland;South Africa;Spain;Sweden;Switzerland;Turkey
40NCT00886769
(ClinicalTrials.gov)
July 200922/4/2009Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic ManifestationsSystemic Juvenile Idiopathic ArthritisDrug: Canakinumab;Drug: PlaceboNovartis PharmaceuticalsInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group;Southwest Pediatric Nephrology Study GroupTerminated2 Years19 YearsAll84Phase 3United States;Argentina;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Norway;Peru;Poland;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom
41EUCTR2008-005476-27-IT
(EUCTR)
22/06/200905/08/2009A randomized, double-blind, placebo controlled, singledose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - NDA randomized, double-blind, placebo controlled, singledose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: canakinumab
Product Code: ACZ885G
INN or Proposed INN: ILARIS
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
42EUCTR2008-008008-42-IT
(EUCTR)
22/06/200905/08/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - NDAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 12.0;Level: LLT;Classification code 10059177;Term: Juvenile arthritis
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: canakinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
43EUCTR2008-005479-82-ES
(EUCTR)
12/06/200905/03/2009Estudio doble ciego, randomizado, controlado con placebo, con diseño de retirada en la prevención de brotes con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301 Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas.
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
44EUCTR2008-008008-42-ES
(EUCTR)
12/06/200901/04/2009Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1Estudio de extensión, abierto, con canakinumab (ACZ885) en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2301E1 Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
45EUCTR2008-005476-27-BE
(EUCTR)
04/06/200927/04/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
46EUCTR2008-005479-82-BE
(EUCTR)
04/06/200914/04/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Phase 3France;Hungary;Greece;Spain;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
47EUCTR2008-008008-42-BE
(EUCTR)
04/06/200909/04/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations WHO PARTICIPATED IN STUDIES ACZ885G2301 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Ilaris
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Peru;Netherlands;Germany;Sweden
48EUCTR2008-005476-27-ES
(EUCTR)
14/05/200903/03/2009Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305Estudio randomizado, doble ciego, controlado con placebo, a dosis única para evaluar la eficacia inicial de canakinumab (ACZ885) respecto a los Criterios ACR 30 Pediátricos Adaptados en pacientes con artritis idiopática juvenil sistémica y manifestaciones sistémicas activas - G2305 Artritis idiopática juvenil sistémica y manifestaciones sistémicas activas.
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
122Phase 3France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
49EUCTR2008-005479-82-FR
(EUCTR)
07/05/200919/03/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestationsA randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Phase 3France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
50EUCTR2008-008008-42-FR
(EUCTR)
07/05/200919/03/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestationsAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
88France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
51EUCTR2008-005476-27-FR
(EUCTR)
07/05/200919/03/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestationsA randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Phase 3France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
52EUCTR2008-008008-42-HU
(EUCTR)
05/05/200907/04/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305;and response characterization study in canakinumab treatment-naïve patients with active SJIA with and without fever - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
304United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Netherlands;Germany;Sweden
53EUCTR2008-005479-82-HU
(EUCTR)
05/05/200906/04/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
214Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden
54EUCTR2008-005476-27-HU
(EUCTR)
04/05/200907/04/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
122Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden
55EUCTR2008-005479-82-NO
(EUCTR)
12/03/2009A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
214Phase 3France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
56EUCTR2012-003054-92-BE
(EUCTR)
26/11/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with systemic juvenile idiopathic arthritis (SJIA)An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) - ß-SPECIFIC 4 Patients Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Peru;Netherlands;Germany;Sweden
57EUCTR2008-008008-42-NO
(EUCTR)
10/03/2009An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
88Phase 3Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
58EUCTR2008-008008-42-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIAAn open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis PharmaServices AGNULLNAFemale: yes
Male: yes
200Peru;Russian Federation;South Africa;Switzerland;Turkey;United States;Argentina;Brazil;Canada;Israel
59EUCTR2008-005476-27-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIAA randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with SystemicJuvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
84Argentina;Brazil;Israel;Peru;Switzerland;Turkey;United States
60EUCTR2008-005479-82-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIAA randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
177Argentina;Brazil;Canada;Israel;Peru;Switzerland;Turkey;United States
61EUCTR2008-005476-27-NO
(EUCTR)
09/03/2009A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2305 Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Canakinumab
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
122Phase 3France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden

108. TNF受容体関連周期性症候群


臨床試験数 : 4 薬物数 : 7 - (DrugBank : 1) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 44
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-020061-24-GB
(EUCTR)
15/11/201018/06/2010 An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203 An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203 TNF-receptor associated periodic syndrome (TRAPS)
MedDRA version: 16.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic syndrome;System Organ Class: 100000004850
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noIreland;Italy;United Kingdom
2EUCTR2010-020061-24-IT
(EUCTR)
20/09/201005/07/2010An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 6-month follow-up in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - NDAn open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 6-month follow-up in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - ND Active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10034533;Term: Periodic fever
Product Name: canakinumab
Product Code: ACZ885D
INN or Proposed INN: Canakinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
50Ireland;United Kingdom;Italy
3EUCTR2010-020061-24-IE
(EUCTR)
24/08/201018/05/2010?A study to check how beneficial and safe the drug canakinumab is for patients with TNF-receptor associated periodic syndrome (TRAPS)An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long-term treatment period in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS) - D2203 TNF-receptor associated periodic syndrome (TRAPS)
MedDRA version: 14.1;Level: LLT;Classification code 10067783;Term: Tumor necrosis factor receptor-associated periodic 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
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
20Ireland;Italy;United Kingdom
4EUCTR2017-001678-40-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

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03936894
(ClinicalTrials.gov)
May 1, 201929/4/2019Single Escalating Dose Pilot Trial of Canakinumab (ILARIS®) in Duchenne Muscular DystrophyA Single Escalating Dose Pilot Trial of Canakinumab (ILARIS®) Assessing Safety and Biomarker Changes in Boys With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: Canakinumab Injection [Ilaris]Children's National Research InstituteFoundation to Eradicate DuchenneRecruiting2 YearsN/AMale6Phase 1/Phase 2United States

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
1EUCTR2013-004291-35-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
2EUCTR2013-004291-35-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
3EUCTR2013-004291-35-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
4EUCTR2013-004291-35-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
5EUCTR2013-004291-35-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
6EUCTR2013-004291-35-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
7EUCTR2013-004291-35-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
8EUCTR2013-004291-35-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
9NCT01148797
(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
10NCT01088880
(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
11EUCTR2015-003522-13-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
12EUCTR2017-001678-40-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
13EUCTR2015-003527-57-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

267. 高IgD症候群


臨床試験数 : 11 薬物数 : 6 - (DrugBank : 1) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 44
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004291-35-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
2EUCTR2013-004291-35-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
3EUCTR2013-004291-35-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
4EUCTR2013-004291-35-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
5EUCTR2013-004291-35-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
6EUCTR2013-004291-35-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
7EUCTR2013-004291-35-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
8EUCTR2013-004291-35-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
9NCT01303380
(ClinicalTrials.gov)
March 201123/2/2011Canakinumab in Patients With Active Hyper-IgD SyndromeAn Open-label, Multicenter, Efficacy and Safety Pilot Study of 6-month Canakinumab Treatment With up to 6-month Follow-up in Patients With Active Hyper-IgD Syndrome (HIDS)Mevalonate Kinase DeficiencyDrug: CanakinumabNovartis PharmaceuticalsNULLCompleted24 MonthsN/AAll9Phase 2Spain
10EUCTR2017-001678-40-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

269. 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群


臨床試験数 : 24 薬物数 : 30 - (DrugBank : 12) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01302795
(ClinicalTrials.gov)
February 201117/2/2011Canakinumab for Pyoderma GangrenosumA Phase II Multi Center Open Label Pilot Study To Assess a Potential Effect of an Anti-Il-1-Beta Antagonist in the Treatment of Pyoderma GangrenosumPyoderma GangrenosumDrug: CanakinumabUniversity of ZurichNULLCompleted18 Years99 YearsBoth5Phase 2Switzerland