Canakinumab (ACZ885) ( DrugBank: Canakinumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
106クリオピリン関連周期熱症候群11

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_
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PhaseCountries
1EUCTR2009-016859-22-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
2EUCTR2009-016859-22-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
3NCT01302860
(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
4EUCTR2009-016859-22-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
5EUCTR2009-016859-22-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
6EUCTR2009-016859-22-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
7NCT01105507
(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
8NCT00685373
(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
9EUCTR2015-003491-69-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
10EUCTR2009-016859-22-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
11EUCTR2009-016859-22-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