Canakinumab (acz885) (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 | 4 |
| 56 | ベーチェット病 | 0 |
| 84 | サルコイドーシス | 0 |
| 106 | クリオピリン関連周期熱症候群 | 11 |
| 107 | 若年性特発性関節炎［全身型若年性特発性関節炎（~2018.3）］ | 55 |
| 108 | TNF受容体関連周期性症候群 | 0 |
| 113 | 筋ジストロフィー | 0 |
| 266 | 家族性地中海熱 | 0 |
| 267 | 高IgD症候群 | 0 |
| 269 | 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群 | 0 |
| 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 | EUCTR2008-005320-81-ES (EUCTR) | 18/02/2009 | 20/01/2009 | Segundo 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 | Segundo 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Germany;Spain;Austria | |||
| 2 | EUCTR2008-005320-81-BE (EUCTR) | 16/02/2009 | 20/02/2009 | A 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 | A 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 AG | Novartis Pharma Belgium | Not Recruiting | Female: yes Male: yes | Spain;Belgium;Austria;Germany | ||||
| 3 | EUCTR2008-005320-81-DE (EUCTR) | 06/02/2009 | 17/11/2008 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 213 | Germany;Spain;Austria | |||
| 4 | EUCTR2008-005320-81-AT (EUCTR) | 21/10/2008 | 22/09/2008 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain;Austria |
| 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 | 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 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | France;Belgium;Spain;Ireland;Germany;United Kingdom | |||
| 2 | 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 | |||
| 3 | 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 |
| 4 | 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 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | France;Belgium;Spain;Ireland;Germany;United Kingdom | |||
| 5 | 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 | |||
| 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 |
| 6 | 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 | |||
| 7 | 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 |
| 8 | 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 |
| 9 | 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 | ||||
| 10 | 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 | ||||
| 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 |
| 11 | 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] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | France;Canada;Belgium;Spain;Ireland;Israel;Germany;United Kingdom;Switzerland |
| 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 | NCT02396212 (ClinicalTrials.gov) | May 7, 2015 | 25/2/2015 | Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA | An 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 Arthritis | Biological: Canakinumab | Novartis Pharmaceuticals | NULL | Completed | 2 Years | 19 Years | All | 19 | Phase 3 | Japan |
| 2 | JPRN-JapicCTI-152865 | 01/4/2015 | Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA | An 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 Arthritis | Intervention 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. | NULL | 2 | 19 | BOTH | 20 | Phase 3 | NULL | ||
| 3 | EUCTR2013-004867-29-NL (EUCTR) | 23/12/2014 | 23/09/2014 | Study of efficacy and safety of dose reduction or dose interval prolongation of canakinumab in patients with SJIA | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2013-004867-29-DE (EUCTR) | 28/11/2014 | 25/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 5 | NCT02296424 (ClinicalTrials.gov) | November 17, 2014 | 10/10/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab | ß-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 Pharmaceuticals | NULL | Completed | 2 Years | 20 Years | All | 182 | Phase 3 | United States;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Turkey;Argentina;Hong Kong;Mexico |
| 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 |
| 6 | EUCTR2013-004867-29-BE (EUCTR) | 07/11/2014 | 29/09/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 7 | EUCTR2013-004867-29-HU (EUCTR) | 04/11/2014 | 25/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 8 | EUCTR2013-004867-29-ES (EUCTR) | 20/10/2014 | 06/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 9 | EUCTR2013-004867-29-IT (EUCTR) | 03/10/2014 | 26/08/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 10 | EUCTR2013-004867-29-SE (EUCTR) | 10/09/2014 | 25/07/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 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 |
| 11 | EUCTR2013-004867-29-AT (EUCTR) | 04/09/2014 | 31/07/2014 | ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab | ß-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3;Phase 4 | United States;Hong Kong;Spain;Turkey;Austria;Russian Federation;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Netherlands;Germany;Sweden | ||
| 12 | EUCTR2012-003054-92-CZ (EUCTR) | 18/04/2013 | 18/12/2012 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | United 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 | |||
| 13 | EUCTR2012-003054-92-ES (EUCTR) | 28/01/2013 | 21/12/2012 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United 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 | |||
| 14 | EUCTR2012-003054-92-AT (EUCTR) | 24/01/2013 | 11/12/2012 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 239 | United 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 | |||
| 15 | NCT01676948 (ClinicalTrials.gov) | January 2013 | 29/8/2012 | An 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 Arthritis | Drug: ACZ885;Drug: Canakinumab | Novartis Pharmaceuticals | PRINTO/PRCSG | Withdrawn | 2 Years | 20 Years | Both | 0 | Phase 3 | Argentina;Austria;Belgium;Brazil;Canada;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States |
| 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 |
| 16 | EUCTR2008-005476-27-GR (EUCTR) | 15/06/2010 | 17/12/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 17 | EUCTR2008-008008-42-GR (EUCTR) | 15/06/2010 | 04/12/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 18 | EUCTR2008-005479-82-GR (EUCTR) | 20/04/2010 | 04/12/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 19 | EUCTR2008-005476-27-GB (EUCTR) | 08/03/2010 | 11/09/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 20 | EUCTR2008-008008-42-AT (EUCTR) | 28/01/2010 | 30/12/2009 | 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 fever - G2301E1 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 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 |
| 21 | EUCTR2008-005479-82-AT (EUCTR) | 17/12/2009 | 02/12/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 22 | EUCTR2008-008008-42-GB (EUCTR) | 16/12/2009 | 11/09/2009 | 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 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United 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 | |||
| 23 | EUCTR2008-005479-82-GB (EUCTR) | 16/12/2009 | 11/09/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;Germany;United Kingdom;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 24 | EUCTR2008-005479-82-DE (EUCTR) | 24/11/2009 | 17/04/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 25 | EUCTR2008-005476-27-DE (EUCTR) | 24/11/2009 | 17/04/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 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 |
| 26 | EUCTR2008-008008-42-DE (EUCTR) | 24/11/2009 | 17/04/2009 | 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 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United 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 | |||
| 27 | EUCTR2008-008008-42-DK (EUCTR) | 10/11/2009 | 30/09/2009 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Hungary;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 28 | EUCTR2008-008008-42-NL (EUCTR) | 05/11/2009 | 25/05/2009 | research with children with severe reuma | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Germany;Netherlands;Sweden | |||
| 29 | EUCTR2008-005476-27-DK (EUCTR) | 28/10/2009 | 28/09/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Sweden | |||
| 30 | EUCTR2008-005479-82-DK (EUCTR) | 28/10/2009 | 30/09/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Belgium;Denmark;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 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 |
| 31 | NCT00891046 (ClinicalTrials.gov) | September 2009 | 29/4/2009 | An 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 Fever | Systemic Juvenile Idiopathic Arthritis | Drug: Canakinumab | Novartis Pharmaceuticals | Pediatric Rheumatology International Trials Organization | Completed | 2 Years | 19 Years | All | 270 | Phase 3 | United 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 |
| 32 | EUCTR2008-005479-82-IT (EUCTR) | 20/07/2009 | 05/08/2009 | 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 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 33 | EUCTR2008-005479-82-SE (EUCTR) | 16/07/2009 | 16/06/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 34 | EUCTR2008-005476-27-SE (EUCTR) | 16/07/2009 | 18/06/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 35 | EUCTR2008-008008-42-SE (EUCTR) | 16/07/2009 | 16/06/2009 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Swaziland;Canada;Argentina;Belgium;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 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 |
| 36 | NCT00886769 (ClinicalTrials.gov) | July 2009 | 22/4/2009 | Single-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 Manifestations | Systemic Juvenile Idiopathic Arthritis | Drug: Canakinumab;Drug: Placebo | Novartis Pharmaceuticals | International Maternal Pediatric Adolescent AIDS Clinical Trials Group;Southwest Pediatric Nephrology Study Group | Terminated | 2 Years | 19 Years | All | 84 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Norway;Peru;Poland;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 37 | NCT00889863 (ClinicalTrials.gov) | July 2009 | 21/4/2009 | Flare 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 Manifestations | Systemic Juvenile Idiopathic Arthritis With Active Flare | Drug: canakinumab;Drug: placebo | Novartis Pharmaceuticals | Pediatric Rheumatology International Trials Organization | Completed | 2 Years | 19 Years | All | 177 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Peru;Poland;South Africa;Spain;Sweden;Switzerland;Turkey |
| 38 | EUCTR2008-008008-42-IT (EUCTR) | 22/06/2009 | 05/08/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - ND | An 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 39 | EUCTR2008-005476-27-IT (EUCTR) | 22/06/2009 | 05/08/2009 | A 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 | A 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 40 | EUCTR2008-005476-27-BE (EUCTR) | 04/06/2009 | 27/04/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 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 |
| 41 | EUCTR2008-008008-42-BE (EUCTR) | 04/06/2009 | 09/04/2009 | 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 ANDACZ885G2305;AND RESPONSE CHARACTERIZATION STUDY IN CANAKINUMAB TREATMENT-NAÏVE PATIENTS WITH ACTIVE SJIA WITH AND WITHOUT FEVER - G2301E1 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 42 | EUCTR2008-005479-82-BE (EUCTR) | 04/06/2009 | 14/04/2009 | 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 manifestations - G2301 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Spain;Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 43 | EUCTR2008-005479-82-FR (EUCTR) | 07/05/2009 | 19/03/2009 | 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 manifestations | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 44 | EUCTR2008-005476-27-FR (EUCTR) | 07/05/2009 | 19/03/2009 | 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 manifestations | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 45 | EUCTR2008-008008-42-FR (EUCTR) | 07/05/2009 | 19/03/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 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 |
| 46 | EUCTR2008-005479-82-HU (EUCTR) | 05/05/2009 | 06/04/2009 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 214 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Austria;Sweden | ||||
| 47 | EUCTR2008-008008-42-HU (EUCTR) | 05/05/2009 | 07/04/2009 | 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 fever - G2301E1 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 304 | United States;Greece;Spain;Turkey;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Denmark;Peru;Netherlands;Germany;Sweden | |||
| 48 | EUCTR2008-005476-27-HU (EUCTR) | 04/05/2009 | 07/04/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Hungary;United Kingdom;Germany;Denmark;Belgium;France;Spain;Italy;Greece;Sweden | |||
| 49 | EUCTR2012-003054-92-BE (EUCTR) | 26/11/2012 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United 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 | |||
| 50 | EUCTR2008-005479-82-NO (EUCTR) | 12/03/2009 | 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 manifestations - G2301 | 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 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 AG | NULL | NA | Female: yes Male: yes | 214 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Austria;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 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 |
| 51 | EUCTR2008-005476-27-NO (EUCTR) | 09/03/2009 | 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 manifestations - G2305 | 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 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 AG | NULL | NA | Female: yes Male: yes | 122 | Phase 3 | France;Hungary;Greece;Belgium;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 52 | EUCTR2008-005479-82-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with 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 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 AG | NULL | NA | Female: yes Male: yes | 177 | Argentina;Brazil;Canada;Israel;Peru;Switzerland;Turkey;United States | ||||
| 53 | EUCTR2008-008008-42-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with SJIA | An 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 AG | NULL | NA | Female: yes Male: yes | 200 | Peru;Russian Federation;South Africa;Switzerland;Turkey;United States;Argentina;Brazil;Canada;Israel | ||||
| 54 | EUCTR2008-008008-42-NO (EUCTR) | 10/03/2009 | An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 | An 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 AG | NULL | NA | Female: yes Male: yes | 88 | Phase 3 | Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 55 | EUCTR2008-005476-27-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with 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 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 AG | NULL | NA | Female: yes Male: yes | 84 | Argentina;Brazil;Israel;Peru;Switzerland;Turkey;United States |