107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details
臨床試験数 : 441 / 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
| 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 | NCT03769168 (ClinicalTrials.gov) | June 7, 2019 | 21/11/2018 | An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Juvenile Psoriatic Arthritis;Enthesitis Related Arthritis | Drug: AIN457 | Novartis Pharmaceuticals | NULL | Active, not recruiting | 2 Years | N/A | All | 56 | Phase 3 | United States;Belgium;Germany;Italy;Poland;Russian Federation;South Africa;Spain;Turkey |
| 2 | EUCTR2018-002521-30-DE (EUCTR) | 09/05/2019 | 08/01/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy | ||
| 3 | EUCTR2018-002521-30-ES (EUCTR) | 15/03/2019 | 27/03/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Belgium;Spain;Turkey;Russian Federation;South Africa;Germany;Italy | ||
| 4 | EUCTR2016-003761-26-PL (EUCTR) | 30/06/2017 | 24/05/2017 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Belgium;Poland;Turkey;South Africa;Russian Federation;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2016-003761-26-BE (EUCTR) | 15/06/2017 | 16/03/2017 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;United Kingdom;Italy | ||
| 6 | NCT03031782 (ClinicalTrials.gov) | May 23, 2017 | 2/11/2016 | Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA) | A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis | Juvenile Psoriatic Arthritis;Enthesitis-related Arthritis | Drug: AIN457;Other: Matched placebo | Novartis Pharmaceuticals | NULL | Completed | 2 Years | 17 Years | All | 86 | Phase 3 | United States;Belgium;Germany;Italy;Poland;Russian Federation;South Africa;Spain;Turkey;United Kingdom |
| 7 | EUCTR2016-003761-26-GB (EUCTR) | 10/03/2017 | 13/12/2016 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;South Africa;Russian Federation;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2016-003761-26-ES (EUCTR) | 01/03/2017 | 15/12/2016 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Poland;Belgium;Spain;Turkey;South Africa;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2016-003761-26-DE (EUCTR) | 06/02/2017 | 12/12/2016 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | United States;Poland;Belgium;Spain;Turkey;Russian Federation;South Africa;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2016-003761-26-IT (EUCTR) | 10/11/2020 | Secukinumab safety and efficacy in JPsA and ERA | A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis - Secukinumab safety and efficacy in JPsA and ERA | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 1 SIRINGA PRERIEMPITA Product Name: NA Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy | |||
| 11 | EUCTR2018-002521-30-PL (EUCTR) | 29/05/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 63 | Phase 3 | United States;Belgium;Spain;Poland;Turkey;Russian Federation;South Africa;Germany;Italy | |||
| 12 | EUCTR2018-002521-30-BE (EUCTR) | 09/07/2019 | An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA) | An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis | Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10072745;Term: Enthesitis related arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: COSENTYX INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 63 | Phase 3 | United States;Spain;Poland;Belgium;Turkey;Italy;Germany;Russian Federation;South Africa |