106. Cryopyrin-associated periodic syndrome Clinical trials / Disease details
Clinical trials : 42 / Drugs : 24 - (DrugBank : 4) / Drug target genes : 4 - Drug target pathways : 48
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2014-001393-34-BE (EUCTR) | 14/04/2014 | 03/04/2014 | 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. | 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 Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 2 | EUCTR2011-005154-57-GB (EUCTR) | 09/03/2013 | 13/11/2013 | 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). | 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 AG | NULL | Not 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): no | France;Canada;Belgium;Spain;Israel;Germany;United Kingdom | ||
| 3 | EUCTR2011-005154-57-FR (EUCTR) | 08/02/2013 | 19/01/2012 | 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). | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | France;Canada;Belgium;Spain;Israel;Germany;United Kingdom | |||
| 4 | EUCTR2009-016859-22-FR (EUCTR) | 04/02/2013 | 14/06/2010 | 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). | 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 AG | NULL | Not 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): no | France;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 5 | EUCTR2011-005154-57-DE (EUCTR) | 04/06/2012 | 01/02/2012 | 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). | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | France;Canada;Spain;Belgium;Israel;Germany;United Kingdom | |||
| 6 | EUCTR2011-005154-57-ES (EUCTR) | 20/03/2012 | 27/01/2012 | An 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.A | NULL | Not Recruiting | Female: yes Male: yes | 16 | France;Canada;Belgium;Spain;Israel;Germany;United Kingdom | |||
| 7 | NCT01576367 (ClinicalTrials.gov) | January 16, 2012 | 17/2/2012 | Efficacy, 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 Disease | 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) | Cryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Biological: ACZ885 | Novartis Pharmaceuticals | NULL | Completed | 1 Year | 4 Years | All | 17 | Phase 3 | Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom |
| 8 | EUCTR2011-005154-57-BE (EUCTR) | 03/01/2012 | 06/12/2011 | 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). | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | France;Canada;Spain;Belgium;Israel;Germany;United Kingdom | ||
| 9 | EUCTR2009-016859-22-DE (EUCTR) | 11/11/2010 | 22/06/2010 | 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 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Belgium;Spain;Germany;United Kingdom | |||
| 10 | NCT01302860 (ClinicalTrials.gov) | November 2010 | 22/2/2011 | Efficacy, 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 Disease | 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;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Drug: ACZ885 | Novartis Pharmaceuticals | NULL | Completed | 1 Month | 60 Months | All | 17 | Phase 3 | Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom |
| 11 | EUCTR2009-016859-22-GB (EUCTR) | 15/10/2010 | 01/07/2010 | 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). | 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 AG | NULL | Not 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): no | France;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 12 | EUCTR2009-016859-22-ES (EUCTR) | 27/08/2010 | 30/06/2010 | 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) | 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.A | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Belgium;Spain;Germany;United Kingdom | |||
| 13 | EUCTR2009-016859-22-BE (EUCTR) | 12/08/2010 | 14/07/2010 | 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 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Belgium;Germany;United Kingdom | |||
| 14 | NCT01105507 (ClinicalTrials.gov) | August 2010 | 25/3/2010 | The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada | An 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 | Drug: canakinumab (company code: ACZ885D) | Novartis Pharmaceuticals | NULL | Completed | 4 Years | N/A | All | 4 | Phase 3 | Canada |
| 15 | EUCTR2007-004367-22-BE (EUCTR) | 16/10/2009 | 21/08/2009 | 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 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | France;Spain;Belgium;Germany;Italy;United Kingdom | |||
| 16 | NCT00991146 (ClinicalTrials.gov) | October 2009 | 6/10/2009 | Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase | An 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 Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Drug: canakinumab | Novartis Pharmaceuticals | NULL | Completed | 2 Years | N/A | All | 19 | Phase 3 | Japan |
| 17 | NCT00770601 (ClinicalTrials.gov) | January 26, 2009 | 9/10/2008 | Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease | A 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 Syndrome | NOMID;CINCA Syndrome | Drug: Canakinumab | Novartis Pharmaceuticals | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Terminated | 2 Years | 25 Years | All | 7 | Phase 3 | United States |
| 18 | EUCTR2007-004367-22-FR (EUCTR) | 18/06/2008 | 03/04/2008 | 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 Muckle-Wells Syndrome with overlapping symptoms of 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | France;Belgium;Spain;Germany;Italy;United Kingdom | |||
| 19 | EUCTR2007-004367-22-DE (EUCTR) | 02/06/2008 | 13/03/2008 | 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 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | United Kingdom;Germany;France;Spain;Italy | |||
| 20 | EUCTR2007-004367-22-GB (EUCTR) | 01/05/2008 | 07/03/2008 | 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 AG | NULL | Not 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): no | France;Belgium;Spain;Germany;Italy;United Kingdom | ||
| 21 | NCT00685373 (ClinicalTrials.gov) | May 2008 | 27/5/2008 | Efficacy 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 Disease | 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 | Cryopyrin-Associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Drug: Canakinumab (ACZ885) | Novartis | NULL | Completed | 3 Years | N/A | All | 166 | Phase 3 | United States;Belgium;France;Germany;India;Italy;Spain;Turkey;United Kingdom |
| 22 | EUCTR2015-003490-15-Outside-EU/EEA (EUCTR) | 14/04/2016 | Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase | An 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 Pharmaceuticals | NULL | NA | Female: yes Male: yes | 20 | Japan | ||||
| 23 | EUCTR2009-016859-22-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 AG | NULL | NA | Female: yes Male: yes | 15 | Canada;Israel;Switzerland | ||||
| 24 | EUCTR2015-003491-69-Outside-EU/EEA (EUCTR) | 14/04/2016 | The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada | An 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 Pharmaceuticals | NULL | NA | Female: yes Male: no | 4 | Canada | ||||
| 25 | EUCTR2009-016859-22-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 AG | NULL | Not 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): no | France;Canada;Belgium;Spain;Ireland;Israel;Germany;United Kingdom;Switzerland | |||
| 26 | EUCTR2007-004367-22-Outside-EU/EEA (EUCTR) | 09/03/2012 | A 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 AG | NULL | NA | Female: yes Male: yes | 166 | India;Turkey;United States | ||||
| 27 | EUCTR2008-001429-32-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drugcanakinumab is for patients with NOMID / CINCA syndrome | A 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 AG | NULL | NA | Female: yes Male: yes | 7 | United States |