107. 若年性特発性関節炎［全身型若年性特発性関節炎（~2018.3）］
［臨床試験数：151，薬物数：75（DrugBank：13），標的遺伝子数：16，標的パスウェイ数：90］
Searched query = "Juvenile idiopathic arthritis", "Systemic juvenile idiopathic arthritis", "Systemic-onset juvenile idiopathic arthritis", "JIA", "SJIA"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | EUCTR2017-002018-29-PL (EUCTR) | 28/10/2020 | 09/08/2020 | Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA Population | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinibe citrate Product Code: CCP-690-550-10 INN or Proposed INN: tofacitinib Other descriptive name: APD421 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;China | ||
| 2 | EUCTR2018-004284-30-DE (EUCTR) | 13/02/2020 | 29/07/2019 | Repsonse to Treatment with Canakinumab without steroids early after diagnosis of systemic onset juvenile idiopathic arthritis / juvenile Still’s disease | Effectiveness of Canakinumab for first line steroid free treatment in systemic onset juvenile idiopathic arthritis / juvenile Still’s disease - CANAKINUMAB FIRST | systemic juvenile idiopathic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Asklepios Klink Sankt Augustin | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Germany | |||
| 3 | NCT04088396 (ClinicalTrials.gov) | February 12, 2020 | 11/9/2019 | A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA | Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis | Systemic Juvenile Idiopathic Arthritis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 1 Year | 17 Years | All | 103 | Phase 3 | Argentina;Austria;Belgium;Brazil;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom |
| 4 | EUCTR2017-004495-60-DE (EUCTR) | 13/01/2020 | 01/08/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | |||
| 5 | EUCTR2017-004495-60-PL (EUCTR) | 12/12/2019 | 23/10/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | ||
| 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 | EUCTR2017-004495-60-DK (EUCTR) | 20/11/2019 | 21/11/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | |||
| 7 | EUCTR2017-004495-60-FR (EUCTR) | 24/09/2019 | 10/07/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 97 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan | ||
| 8 | EUCTR2017-004495-60-GB (EUCTR) | 19/08/2019 | 11/07/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | ||
| 9 | NCT03932344 (ClinicalTrials.gov) | April 10, 2019 | 16/4/2019 | Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | A Non-interventional, Post-authorization Safety Study (PASS) to Evaluate Long-term Safety of Anakinra (Kineret®) in Patients With Systemic Juvenile Idiopathic Arthritis | Still Disease, Juvenile Onset | Drug: Anakinra | Swedish Orphan Biovitrum | NULL | Completed | N/A | N/A | All | 306 | Italy | |
| 10 | NCT02991469 (ClinicalTrials.gov) | August 9, 2018 | 14/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis | Drug: Sarilumab SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Recruiting | 1 Year | 17 Years | All | 72 | Phase 2 | Argentina;Canada;Czechia;Finland;France;Germany;Italy;Russian Federation;Spain;United Kingdom;Chile;Estonia;Netherlands;Poland;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 |
| 11 | EUCTR2016-004223-23-NL (EUCTR) | 09/08/2018 | 13/02/2018 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | United States;France;Canada;Spain;Germany;Netherlands;United Kingdom;Italy | ||
| 12 | NCT03000439 (ClinicalTrials.gov) | May 10, 2018 | 9/11/2016 | A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA | EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS | Arthritis Juvenile Idiopathic | Drug: In open-label phase: treatment with tofacitinib;Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio | Pfizer | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;China;Israel;Mexico;Russian Federation;South Africa;Turkey;Ukraine |
| 13 | NCT03301883 (ClinicalTrials.gov) | April 26, 2018 | 21/9/2017 | A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA) | A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab;Drug: NSAIDs;Drug: CSs;Drug: MTX | Hoffmann-La Roche | NULL | Recruiting | 2 Years | 17 Years | All | 74 | Phase 4 | China |
| 14 | NCT03311854 (ClinicalTrials.gov) | March 2, 2018 | 21/8/2017 | A Study to Investigate the Safety and Efficacy of an Anti-IFN-gamma mAb in Children With Systemic Juvenile Idiopathic Arthritis (sJIA) Developing Macrophage Activation Syndrome/ Secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of NI-0501, an Anti-interferon Gamma (Anti-IFN?) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) | Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile | Drug: NI-0501 | NovImmune SA | NULL | Active, not recruiting | N/A | 18 Years | All | 10 | Phase 2 | United States;France;Italy;Netherlands;Spain;United Kingdom |
| 15 | ChiCTR-OPB-17013704 | 2017-12-20 | 2017-12-05 | A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis | A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis | systemic juvenile idiopathic arthritis | Case series:Tocilizumab; | Children's Hospital of Chongqing Medical University | NULL | Recruiting | 2 | 17 | Both | Case series:65; | Phase 4 | China |
| 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 | EUCTR2015-004000-35-DE (EUCTR) | 16/11/2017 | 19/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic Arthritis MedDRA version: 23.1;Level: PT;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: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | ||
| 17 | EUCTR2016-004223-23-ES (EUCTR) | 25/09/2017 | 09/06/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: NI-0501 INN or Proposed INN: Emapalumab Other descriptive name: NI-0501 | Novimmune SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 18 | EUCTR2016-004223-23-GB (EUCTR) | 12/09/2017 | 02/03/2017 | A study to investigate a new medication, emapalumab, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB | Swedish Orphan Biovitrum AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Canada;Spain;Netherlands;Italy;United Kingdom | ||
| 19 | ChiCTR-INR-17011829 | 2017-08-01 | 2017-07-02 | Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab | Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab | Systemic onset juvenile idiopathic arthritis | Case:Tocilizumab;Control:Conventional Treatment; | Shenzhen Children's Hospital | NULL | Pending | Both | Case:75;Control:75; | China | |||
| 20 | EUCTR2015-004000-35-NL (EUCTR) | 19/04/2017 | 07/12/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - | Juvenile Idiopathic Arthritis 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 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 | EUCTR2016-004223-23-IT (EUCTR) | 14/04/2017 | 25/01/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: NI-0501 | Novimmune SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 22 | EUCTR2015-004000-35-GB (EUCTR) | 24/02/2017 | 18/08/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic Arthritis MedDRA version: 21.0;Level: PT;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: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | ||
| 23 | EUCTR2015-004000-35-PL (EUCTR) | 13/02/2017 | 05/12/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis MedDRA version: 20.0;Level: PT;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: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 24 | EUCTR2015-004000-35-FI (EUCTR) | 12/12/2016 | 06/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic Arthritis MedDRA version: 21.0;Level: PT;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: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | ||
| 25 | EUCTR2015-004000-35-EE (EUCTR) | 15/11/2016 | 04/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 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 | EUCTR2015-004000-35-ES (EUCTR) | 10/11/2016 | 26/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 27 | EUCTR2015-004000-35-IT (EUCTR) | 17/10/2016 | 07/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | ||
| 28 | EUCTR2015-004393-16-NL (EUCTR) | 04/10/2016 | 08/07/2016 | Biomarker-guided treatment-and-stop-strategy for short acting IL-1 blockade in patients with systemic Juvenile Idiopathic Arthritis. | Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis. - ESTIS trial: Early Stop of targeted Treatment in children with Systemic JIA | systemic Juvenile Idiopathic Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: kineret® or anakinra Product Name: anakinra / kineret Product Code: not applicable INN or Proposed INN: ANAKINRA Other descriptive name: rIL-1RA | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 29 | JPRN-UMIN000024178 | 2016/09/28 | 28/09/2016 | Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis | Systemic-onset juvenile idiopathic arthritis(sJIA) | Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeks | Yokohama City University Hospital Department of Pediatrics | NULL | Recruiting | 2years-old | Not applicable | Male and Female | 5 | Not selected | Japan | |
| 30 | ChiCTR-OPC-17011391 | 2016-09-01 | 2017-05-12 | The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China | The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China | systemic juvenile idiopathic arthritis | tocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid; | Children's Hospital of Chongqing Medical University | NULL | Completed | 2 | 16 | Both | tocilizumab group:36;glucocorticoid group:24; | China | |
| 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 | EUCTR2015-000435-33-GB (EUCTR) | 18/08/2015 | 17/07/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | |||
| 32 | EUCTR2015-000435-33-BE (EUCTR) | 12/08/2015 | 19/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Spain;Belgium;Russian Federation;Germany;Italy;United Kingdom | ||
| 33 | EUCTR2015-000435-33-DE (EUCTR) | 07/08/2015 | 10/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2015-000435-33-HU (EUCTR) | 27/07/2015 | 10/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 35 | EUCTR2015-000435-33-PL (EUCTR) | 07/07/2015 | 03/07/2015 | A study to assess the pharmacokinetics and safety of tocilizumab inpatients less than 2 years old with Active Systemic Juvenile IdiopathicArthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Belgium;Spain;Poland;Russian Federation;Germany;Italy;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 |
| 36 | EUCTR2015-000435-33-ES (EUCTR) | 26/06/2015 | 29/06/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 1 | France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom | ||
| 37 | 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 |
| 38 | ChiCTR-OOC-15006228 | 2015-04-01 | 2015-04-09 | Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritis | Clinical and mechanism research of extracellular histone in systemic-onset juvenile idiopathic arthritis | systemic-onset juvenile idiopathic arthritis | disease active group,disease remission group:add heparin into neutrophils in vitro; | Shanghai Children's Medical Center | NULL | Recruiting | 3 | 16 | Both | disease active group,disease remission group:30; | China | |
| 39 | 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 | ||
| 40 | 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 | ||
| 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 | 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 | ||
| 42 | 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 |
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | NCT02334748 (ClinicalTrials.gov) | November 3, 2014 | 23/12/2014 | A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies | A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF) | Systemic Juvenile Idiopathic Arthritis;Hereditary Periodic Fevers | Drug: canakinumab | Novartis Pharmaceuticals | NULL | Completed | 5 Years | 20 Years | All | 31 | Phase 3 | France |
| 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 | 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 | ||
| 47 | 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 | ||
| 48 | EUCTR2014-002872-95-FR (EUCTR) | 15/09/2014 | 18/06/2015 | A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1 | A French open-label extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who participated in the international phase III study CACZ885G2301E1 - CACZ885GFR01 | Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma S.A.S | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | France | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 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 | NCT02165345 (ClinicalTrials.gov) | July 16, 2014 | 13/6/2014 | Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis | Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 2 Years | 18 Years | All | 82 | Phase 1 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom |
| 52 | EUCTR2013-005212-98-IT (EUCTR) | 09/07/2014 | 20/05/2014 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA); 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: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany | |||
| 53 | EUCTR2013-005212-98-DE (EUCTR) | 30/06/2014 | 19/05/2014 | Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 20.0;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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 54 | EUCTR2013-005212-98-ES (EUCTR) | 16/06/2014 | 09/06/2014 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA); 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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC | Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany | |||
| 55 | EUCTR2013-005212-98-GB (EUCTR) | 21/05/2014 | 20/05/2014 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 21.0;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] | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 104 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;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 |
| 56 | NCT01904292 (ClinicalTrials.gov) | August 15, 2013 | 14/6/2013 | A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis | A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 1 Year | 17 Years | All | 52 | Phase 1 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom |
| 57 | EUCTR2012-003490-26-DE (EUCTR) | 08/08/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | 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] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 58 | EUCTR2012-003490-26-ES (EUCTR) | 26/06/2013 | 26/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | 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: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 59 | EUCTR2012-003490-26-GB (EUCTR) | 14/06/2013 | 20/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | 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] | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | |||
| 60 | EUCTR2012-003490-26-IT (EUCTR) | 11/06/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | 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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;United Kingdom;Italy | ||
| 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 |
| 61 | 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 | |||
| 62 | 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 | |||
| 63 | 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 | |||
| 64 | EUCTR2012-000444-10-IT (EUCTR) | 22/01/2013 | 11/01/2013 | A STUDY TO LOOK AT LESS FREQUENT DOSING IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO HAVE EXPERIENCED A LABORATORY ABNORMALITY DURING TREATMENT WITH TOCILIZUMAB | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | 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: RoActemra INN or Proposed INN: TOCILIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Mexico;Canada;Spain;Australia;Germany;United Kingdom;Italy;Sweden | ||
| 65 | 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 |
| 66 | EUCTR2012-000444-10-DE (EUCTR) | 30/11/2012 | 28/09/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 20.0;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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 43 | Phase 4 | Sweden;Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom | ||
| 67 | EUCTR2012-000444-10-ES (EUCTR) | 22/11/2012 | 14/09/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 15.0;Level: LLT;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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Mexico;Canada;Spain;Australia;Germany;Norway;Italy;United Kingdom;Sweden | ||
| 68 | EUCTR2012-000444-10-GB (EUCTR) | 09/11/2012 | 21/08/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 21.0;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] | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 43 | Phase 4 | Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom;Sweden | |||
| 69 | EUCTR2012-000444-10-SE (EUCTR) | 01/11/2012 | 04/10/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 20.0;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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 43 | Phase 4 | Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;United Kingdom;Italy;Sweden | ||
| 70 | NCT01455701 (ClinicalTrials.gov) | October 26, 2012 | 18/10/2011 | A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) | A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) | Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | N/A | 24 Months | All | 11 | Phase 1 | United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;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 |
| 71 | 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 | |||
| 72 | 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 | |||
| 73 | 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 | ||||
| 74 | 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 | |||
| 75 | 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 |
| 76 | 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 | ||||
| 77 | 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 | ||||
| 78 | 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 | |||
| 79 | 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 | |||
| 80 | 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 | ||||
| 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 |
| 81 | 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 | |||
| 82 | 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 | ||||
| 83 | 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 | |||
| 84 | 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 | |||
| 85 | 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 |
| 86 | 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 |
| 87 | 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 | ||||
| 88 | 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 | |||
| 89 | 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 | ||||
| 90 | 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 | |||
| 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 |
| 91 | 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 |
| 92 | 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 |
| 93 | 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 | |||
| 94 | 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 | |||
| 95 | 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 | |||
| 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 |
| 96 | 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 | ||
| 97 | 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 | |||
| 98 | 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 | ||
| 99 | 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 | |||
| 100 | 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 | ||
| 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 |
| 101 | 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 | |||
| 102 | 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 | ||||
| 103 | 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 | |||
| 104 | NCT00868751 (ClinicalTrials.gov) | March 2009 | 24/3/2009 | Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis | Single Patient Use of Tocilizumab for Treatment of Steroid Dependent, Active Systemic Onset Juvenile Idiopathic Arthritis | Arthritis, Juvenile Rheumatoid;Still's Disease, Juvenile Onset | Biological: tocilizumab | Tufts Medical Center | Hoffmann-La Roche | Terminated | 2 Years | 16 Years | All | 1 | N/A | United States |
| 105 | EUCTR2007-000872-18-NL (EUCTR) | 01/12/2008 | 06/03/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA, Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Germany;Netherlands;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 |
| 106 | NCT00534495 (ClinicalTrials.gov) | November 2008 | 24/9/2007 | Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults | Randomized Placebo Phase Study of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT) | Juvenile Idiopathic Arthritis | Biological: Rilonacept | Montefiore Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 18 Months | 19 Years | All | 71 | Phase 2 | United States |
| 107 | EUCTR2007-000872-18-CZ (EUCTR) | 16/10/2008 | 26/02/2008 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | 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: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden | |||
| 108 | EUCTR2007-000872-18-GB (EUCTR) | 03/10/2008 | 26/08/2009 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | 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 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden | |||
| 109 | JPRN-UMIN000001457 | 2008/10/01 | 28/10/2008 | The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial | Adult Still's disease and systemic juvenile idiopathic arthritis | Tocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weight | Division of Rheumatology & Clinical Immunology, Jichi Medical University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 110 | EUCTR2007-000872-18-GR (EUCTR) | 09/09/2008 | 21/03/2008 | A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab | A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab Other descriptive name: MRA (Actemra) | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | United Kingdom;Slovakia;Czech Republic;Germany;Netherlands;Denmark;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 |
| 111 | EUCTR2007-000872-18-DE (EUCTR) | 11/07/2008 | 14/02/2008 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 14.0;Level: LLT;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: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Norway;Sweden | |||
| 112 | JPRN-UMIN000001250 | 2008/07/01 | 16/07/2008 | Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial | Adult Still's disease or systemic juvenile idiopathic arthritis | Tocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks. | Division of Rheumatology & Clinical Immunology, Jichi Medical University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 113 | EUCTR2007-000872-18-DK (EUCTR) | 27/06/2008 | 05/03/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA Other descriptive name: Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 114 | EUCTR2007-000872-18-SK (EUCTR) | 09/06/2008 | 09/04/2008 | A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 115 | EUCTR2007-000872-18-ES (EUCTR) | 23/05/2008 | 26/02/2008 | Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER | Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER | Artritis idiopatica juvenil sistémica (sJIA)Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Belgium;Spain;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 |
| 116 | EUCTR2007-000872-18-IT (EUCTR) | 12/05/2008 | 23/03/2009 | A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND | A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Name: ACTEMRA Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 117 | NCT00642460 (ClinicalTrials.gov) | May 2008 | 19/3/2008 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA) | A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab | Juvenile Idiopathic Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroids | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 112 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France |
| 118 | EUCTR2007-000872-18-BE (EUCTR) | 15/04/2008 | 29/01/2008 | The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER | 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;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden | |||
| 119 | EUCTR2007-000872-18-SE (EUCTR) | 07/04/2008 | 05/02/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA, Actemra | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 120 | EUCTR2006-001834-42-GB (EUCTR) | 27/04/2007 | 14/10/2010 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885A2203 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) - CACZ885A2203 | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 8.1;Level: PT;Classification code 10059177;Term: Juvenile arthritis | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 26 | Phase 2 | France;Italy;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 |
| 121 | EUCTR2006-001834-42-FR (EUCTR) | 17/04/2007 | 05/10/2006 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1ß Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 8.1;Level: PT;Classification code 10059177;Term: Juvenile arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 26 | France;United Kingdom;Italy | |||
| 122 | NCT00426218 (ClinicalTrials.gov) | December 2006 | 23/1/2007 | Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) | Arthritis, Juvenile Rheumatoid | Drug: ACZ885 | Novartis | NULL | Completed | 4 Years | 20 Years | Both | 26 | Phase 1;Phase 2 | Italy |
| 123 | EUCTR2006-001834-42-IT (EUCTR) | 13/10/2006 | 09/01/2007 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203 | A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203 | Sistemic Juvenile Idiopathic Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Code: ACZ885 Product Code: ACZ885 Product Code: ACZ885 | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;France;Italy | ||||
| 124 | EUCTR2006-000089-35-IT (EUCTR) | 17/08/2006 | 30/08/2006 | Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND | Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND | systemic onset juvenile idiopathic arthritis Level: PTClassification code 10059177 | Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 125 | NCT00570661 (ClinicalTrials.gov) | August 2006 | 10/12/2007 | Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) | Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) | Active Systemic;Onset Juvenile Idiopathic Arthritis | Drug: ITF2357 | Italfarmaco | NULL | Completed | 2 Years | 25 Years | Both | 17 | Phase 2 | Serbia;Former Serbia and Montenegro |
| 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 |
| 126 | NCT00339157 (ClinicalTrials.gov) | June 2006 | 16/6/2006 | Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS | ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS) | Systemic-Onset Juvenile Idiopathic Arthritis | Drug: Anakinra;Biological: Pneumo23 | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Completed | 2 Years | 20 Years | Both | 24 | Phase 2;Phase 3 | France |
| 127 | NCT01803321 (ClinicalTrials.gov) | November 2005 | 28/2/2013 | Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) | A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) | Systemic Juvenile Idiopathic Arthritis | Drug: rilonacept (IL-1 Trap);Other: Placebo | Regeneron Pharmaceuticals | NULL | Completed | 4 Years | 20 Years | Both | 24 | Phase 1 | United States |
| 128 | EUCTR2005-004008-36-IT (EUCTR) | 27/10/2005 | 30/01/2012 | Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis | Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis | CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: KINERET*SC 7SIR 100MG 0,67ML INN or Proposed INN: Anakinra | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 129 | NCT00144664 (ClinicalTrials.gov) | November 2004 | 2/9/2005 | Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) | An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA | Systemic Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 19 | Phase 3 | NULL |
| 130 | NCT00144612 (ClinicalTrials.gov) | July 2004 | 2/9/2005 | Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP | Systemic Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab) | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 60 | Phase 3 | NULL |
| 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 |
| 131 | NCT00144599 (ClinicalTrials.gov) | May 2004 | 2/9/2005 | Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) | A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA | Systemic Juvenile Idiopathic Arthritis | Drug: MRA(Tocilizumab);Drug: placebo | Chugai Pharmaceutical | NULL | Completed | 2 Years | 19 Years | Both | 56 | Phase 3 | NULL |
| 132 | EUCTR2017-004495-60-BE (EUCTR) | 14/08/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 103 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | ||||
| 133 | EUCTR2017-004495-60-AT (EUCTR) | 05/08/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 103 | Phase 3 | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China | ||||
| 134 | 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 | ||||
| 135 | EUCTR2012-000444-10-NO (EUCTR) | 27/09/2012 | A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab | A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB | 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: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Mexico;Canada;Spain;Australia;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 |
| 136 | EUCTR2015-004000-35-BG (EUCTR) | 12/11/2020 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic Arthritis MedDRA version: 23.1;Level: PT;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: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | NA | Female: yes Male: yes | 72 | Phase 2 | Poland;Bulgaria;Netherlands;Germany;Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Argentina | |||
| 137 | JPRN-JapicCTI-050017 | 02/09/2005 | Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA) | Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA) | sJIA | Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion | Chugai Pharmaceutical Co., Ltd. | NULL | 2 | 19 | Phase 3 | NULL | ||||
| 138 | EUCTR2017-004495-60-CZ (EUCTR) | 02/09/2019 | A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia) | A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: ly3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 103 | Phase 3 | Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan | |||
| 139 | EUCTR2016-004223-23-FR (EUCTR) | 13/02/2017 | A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH) | A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB Other descriptive name: Fully human anti-interferon gamma monoclonal antibody | Novimmune SA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | United States;France;Canada;Spain;Netherlands;Italy;United Kingdom | |||
| 140 | 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 | |||
| 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 |
| 141 | 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 | |||
| 142 | EUCTR2012-003490-26-Outside-EU/EEA (EUCTR) | 22/08/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | 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] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 48 | Phase Ib | Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico | |||
| 143 | 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 | |||
| 144 | EUCTR2015-004000-35-CZ (EUCTR) | 13/10/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase - SKYPS | Juvenile Idiopathic Arthritis MedDRA version: 21.0;Level: PT;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: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | NA | Female: yes Male: yes | 72 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Netherlands | |||
| 145 | EUCTR2013-005212-98-FR (EUCTR) | 17/06/2015 | Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients. | LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA); 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] | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 1 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany | ||||
| 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 |
| 146 | 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 | ||||
| 147 | 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 | |||
| 148 | 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 | ||||
| 149 | EUCTR2007-000872-18-NO (EUCTR) | 20/02/2008 | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab. | A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab. | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: Actemra, MRA | F. Hoffmann-La Roche Limited | NULL | NA | Female: yes Male: yes | 108 | Phase 3 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden | |||
| 150 | EUCTR2015-000435-33-FR (EUCTR) | 24/07/2015 | A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis. | A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) | 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] | Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 10 | Phase 1 | United States;France;Hungary;Canada;Argentina;Poland;Belgium;Spain;Russian Federation;Germany;Italy;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 |
| 151 | EUCTR2015-004000-35-FR (EUCTR) | 22/09/2016 | A Repeated Dose-finding Study of Sarilumab in Children and Adolescents with Systemic Juvenile Idiopathic Arthritis (sJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase | Juvenile Idiopathic Arthritis 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] - Immune System Diseases [C20] | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany |