107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
| 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 | EUCTR2015-004000-35-IE (EUCTR) | 24/06/2021 | 19/02/2021 | 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 | Argentina;Poland;Bulgaria;Netherlands;Germany;Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada | ||
| 2 | EUCTR2015-004000-35-BG (EUCTR) | 12/01/2021 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Czechia;Estonia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Bulgaria;Netherlands;Germany | ||
| 3 | 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;Bulgaria;Canada;Czechia;Finland;France;Germany;Ireland;Italy;Russian Federation;Spain;United Kingdom;Chile;Estonia;Netherlands;Poland;United States |
| 4 | 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 | ||
| 5 | 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: 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 | 36 | Phase 2 | United States;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Netherlands;Germany | ||
| 6 | 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 | ||
| 7 | EUCTR2015-003999-79-DE (EUCTR) | 22/02/2017 | 14/07/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 8 | 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 | Argentina;Russian Federation;United States;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Ireland;Finland;Poland;Italy;Mexico;Chile;France;Bulgaria;Germany;Estonia | ||
| 9 | 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: 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;Czechia;Estonia;Finland;Spain;Chile;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Bulgaria;Germany;Netherlands | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | EUCTR2015-003999-79-NL (EUCTR) | 28/09/2016 | 01/06/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis 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] - Immune System Diseases [C20] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB 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;Netherlands;Germany | ||
| 14 | EUCTR2015-003999-79-PL (EUCTR) | 22/08/2016 | 07/07/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | 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 | Not Recruiting | 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 | ||
| 15 | EUCTR2015-003999-79-IT (EUCTR) | 10/06/2016 | 07/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis 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] - 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;Netherlands;Germany | ||
| 16 | EUCTR2015-003999-79-FI (EUCTR) | 23/05/2016 | 22/04/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP | 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 | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | Argentina;Russian Federation;United States;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Finland;Poland;Italy;Mexico;Chile;France;Germany;Estonia | ||
| 17 | EUCTR2015-003999-79-CZ (EUCTR) | 11/05/2016 | 09/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | ||
| 18 | EUCTR2015-003999-79-ES (EUCTR) | 04/05/2016 | 18/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis 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] - 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;Netherlands;Germany | ||
| 19 | EUCTR2015-003999-79-Outside-EU/EEA (EUCTR) | 08/04/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase | Juvenile idiopathic arthritis 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] - 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 | 36 | Spain;United Kingdom;United States;Argentina;Canada;Chile;Czech Republic;Estonia;Finland;France;Germany;Italy;Mexico;Netherlands;Poland;Russian Federation | ||||
| 20 | EUCTR2015-003999-79-EE (EUCTR) | 14/04/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) 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 | NA | 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;Netherlands;Germany | |||
| 21 | 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 | Not Recruiting | 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;Bulgaria;Germany;Netherlands | |||
| 22 | 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] | Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: SARILUMAB | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Netherlands;Germany | |||
| 23 | EUCTR2015-003999-79-GB (EUCTR) | 01/03/2016 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase - SKYPP | 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 | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany | |||
| 24 | EUCTR2015-003999-79-FR (EUCTR) | 21/06/2018 | An open-label, ascending, repeated, dose-finding study of Sarilumab in children and adolescents with polyarticular-course juvenile idiopathic arthritis (pcJIA) | An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) 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 | NA | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Russian Federation;Chile;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Netherlands;Germany |