107. 若年性特発性関節炎 ［臨床試験数：45，薬物数：39（DrugBank：10），標的遺伝子数：13，標的パスウェイ数：80］
Searched query = "Systemic juvenile idiopathic arthritis", "Systemic onset juvenile idiopathic arthritis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04088396 | October 31, 2019 | 11 November 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 | Not 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 | |
| 2 | NCT03932344 | April 10, 2019 | 4 November 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 | Not recruiting | N/A | N/A | All | 306 | N/A | Italy | |
| 3 | NCT02991469 | August 9, 2018 | 11 November 2019 | 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;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Chile;Estonia;United States |
| 4 | NCT03000439 | May 10, 2018 | 30 September 2019 | 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 | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;China;Israel;Mexico;Russian Federation;South Africa;Turkey;Ukraine | |
| 5 | NCT03301883 | April 26, 2018 | 4 November 2019 | 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 | Recruiting | 2 Years | 17 Years | All | 74 | Phase 4 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03311854 | March 2, 2018 | 26 August 2019 | 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 | Recruiting | N/A | 18 Years | All | 10 | Phase 2 | United States;France;Italy;Netherlands;Spain;United Kingdom | |
| 7 | ChiCTR-OPB-17013704 | 2017-12-20 | 11 December 2017 | 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 | Recruiting | 2 | 17 | Both | Case series:65; | Post-market | China | |
| 8 | EUCTR2016-004223-23-ES | 25/09/2017 | 2 October 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Emapalumab Current Sponsor code: NI-0501 Other descriptive name: NI-0501 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | Novimmune SA | Authorised | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;Italy;United Kingdom | |||
| 9 | ChiCTR-INR-17011829 | 2017-08-01 | 3 July 2017 | 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 | Not Recruiting | Both | Case:75;Control:75; | New Treatment Measure Clinical Study | China | |||
| 10 | EUCTR2016-004223-23-IT | 14/04/2017 | 19 March 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: 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 Pharmaceutical Form: Concentrate for solution for infusion | Novimmune SA | Authorised | Female: yes Male: yes | 5 | Phase 2 | France;Spain;Netherlands;Germany;United Kingdom;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2015-004000-35-GB | 24/02/2017 | 7 May 2018 | 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) Pharmaceutical Form: Solution for injection INN or Proposed INN: SARILUMAB Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175- | sanofi-aventis recherche & développement | Authorised | 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 | |||
| 12 | EUCTR2015-004393-16-NL | 04/10/2016 | 24 October 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 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0 Current Sponsor code: Anakinra Other descriptive name: rIL-1RA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | University Medical Center Utrecht | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| 13 | JPRN-UMIN000024178 | 2016/09/28 | 2 April 2019 | 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 | Recruiting | 2years-old | Not applicable | Male and Female | 5 | Not selected | Japan | ||
| 14 | ChiCTR-OPC-17011391 | 2016-09-01 | 22 May 2017 | 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 | Not Recruiting | 2 | 16 | Both | tocilizumab group:36;glucocorticoid group:24; | Post-market | China | |
| 15 | EUCTR2016-004223-23-FR | 23 July 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: 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: EMAPALUMAB Current Sponsor code: NI-0501 Other descriptive name: Fully human anti-interferon gamma monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | Novimmune SA | Not Available | Female: yes Male: yes | 10 | Phase 2 | United States;France;Canada;Spain;Netherlands;Italy;United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02396212 | May 7, 2015 | 1 October 2018 | 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 | Not recruiting | 2 Years | 19 Years | All | 19 | Phase 3 | Japan | |
| 17 | ChiCTR-OOC-15006228 | 2015-04-01 | 18 April 2017 | 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 | Recruiting | 3 | 16 | Both | disease active group,disease remission group:30; | Other | China | |
| 18 | JPRN-JapicCTI-152865 | 01/4/2015 | 2 April 2019 | 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. | 2 | 19 | BOTH | 20 | Phase 3 | |||
| 19 | EUCTR2015-004000-35-FR | 28 February 2019 | 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) Pharmaceutical Form: Solution for injection INN or Proposed INN: SARILUMAB Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175- | sanofi-aventis recherche & développement | 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 | ||||
| 20 | NCT02334748 | November 3, 2014 | 21 January 2019 | 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 | Not recruiting | N/A | N/A | All | 31 | Phase 3 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2014-002872-95-FR | 15/09/2014 | 10 September 2018 | 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 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: CANAKINUMAB CAS Number: 914613-48-2 Current Sponsor code: ACZ885 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma S.A.S | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | France | |||
| 22 | EUCTR2013-004867-29-SE | 10/09/2014 | 20 August 2018 | 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) | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: CANAKINUMAB CAS Number: 914613-48-2 Current Sponsor code: ACZ885 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | 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 | |||
| 23 | NCT02165345 | July 16, 2014 | 30 September 2019 | 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 | 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 | |
| 24 | EUCTR2013-005212-98-DE | 30/06/2014 | 18 June 2018 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 104 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | |||
| 25 | EUCTR2012-003490-26-DE | 08/08/2013 | 2 October 2017 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01676948 | January 2013 | 26 October 2015 | 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 | Not recruiting | 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 |
| 27 | EUCTR2012-000444-10-GB | 09/11/2012 | 14 March 2016 | 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: 18.1 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 43 | Phase 4 | Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom;Sweden | |||
| 28 | NCT01455701 | October 26, 2012 | 11 November 2019 | 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 | Not recruiting | N/A | 24 Months | All | 11 | Phase 1 | United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;United Kingdom | |
| 29 | NCT00891046 | September 2009 | 1 April 2019 | 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 | Not recruiting | 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 |
| 30 | NCT00868751 | March 2009 | 16 December 2017 | 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 | Not recruiting | 2 Years | 16 Years | All | 1 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT00534495 | November 2008 | 19 October 2017 | 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) | Not recruiting | 18 Months | 19 Years | All | 71 | Phase 2 | United States |
| 32 | JPRN-UMIN000001457 | 2008/10/01 | 2 April 2019 | 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 | Not Recruiting | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan | ||
| 33 | JPRN-UMIN000001250 | 2008/07/01 | 2 April 2019 | 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 | Not Recruiting | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan | ||
| 34 | EUCTR2007-000872-18-BE | 15/04/2008 | 17 August 2015 | 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) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd. | 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 | ||||
| 35 | EUCTR2008-008008-42-NO | 2 October 2017 | 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 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Canakinumab Current Sponsor code: ACZ885 Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Name: Canakinumab Product Code: ACZ885 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Canakinumab Current Sponsor code: ACZ885 Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | Not Available | Female: yes Male: yes | 88 | Phase 3 | Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2006-001834-42-FR | 17/04/2007 | 10 July 2015 | 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ACZ885 Drug Substance Current Sponsor code: ACZ885 Other descriptive name: ACZ885 Drug Substance Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 26 | France;United Kingdom;Italy | ||||
| 37 | NCT00426218 | December 2006 | 19 February 2015 | 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 | Not recruiting | 4 Years | 20 Years | Both | 26 | Phase 1/Phase 2 | Italy | |
| 38 | EUCTR2006-000089-35-IT | 17/08/2006 | 19 March 2012 | 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: PT Classification code 10059177 | Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | ITALFARMACO | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | |||
| 39 | NCT00339157 | June 2006 | 19 February 2015 | 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 | Not recruiting | 2 Years | 20 Years | Both | 24 | Phase 2/Phase 3 | France | |
| 40 | NCT01803321 | November 2005 | 19 February 2015 | 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 | Not recruiting | 4 Years | 20 Years | Both | 24 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2005-004008-36-IT | 27/10/2005 | 18 April 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anakinra Concentration unit: mg milligram(s) Concentration number: 100- | ISTITUTO GIANNINA GASLINI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 42 | NCT00144664 | November 2004 | 19 February 2015 | 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 | Not recruiting | 2 Years | 19 Years | Both | 19 | Phase 3 | ||
| 43 | NCT00144612 | July 2004 | 19 February 2015 | 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 | Not recruiting | 2 Years | 19 Years | Both | 60 | Phase 3 | ||
| 44 | NCT00144599 | May 2004 | 19 February 2015 | 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 | Not recruiting | 2 Years | 19 Years | Both | 56 | Phase 3 | ||
| 45 | JPRN-JapicCTI-050017 | 23 April 2019 | 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. | 2 | 19 | Phase 3 |