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 | NCT01557452 (ClinicalTrials.gov) | December 2011 | 14/3/2012 | An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA) | An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA) JIA | Juvenile Idiopathic Arthritis | Drug: Givinostat | Italfarmaco | Parexel | Terminated | 2 Years | 18 Years | Both | 1 | N/A | Czech Republic |
| 2 | EUCTR2011-003341-18-CZ (EUCTR) | 14/10/2011 | 05/09/2011 | NAP | An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) - - | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) 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: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl- phenyl carbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride; monohydrate | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 3 | Czech Republic | |||
| 3 | EUCTR2010-019094-15-BE (EUCTR) | 07/12/2010 | 20/05/2010 | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Czech Republic;Slovenia;Spain;Belgium;Italy | ||
| 4 | NCT01261624 (ClinicalTrials.gov) | October 2010 | 15/12/2010 | Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis | A Multicenter, Open Label, Dose Finding Study to Evaluate Efficacy and Safety of Givinostat Administered in Two Different Doses in Patients With Poly JIA Not Adequately Responding to the Standard Treatment. | Polyarticular Course Juvenile Idiopathic Arthritis | Drug: Givinostat | Italfarmaco | NULL | Terminated | 2 Years | 17 Years | All | 16 | Phase 2 | Belgium;Czech Republic;Italy;Romania;Serbia;Slovenia;Spain |
| 5 | EUCTR2010-019094-15-ES (EUCTR) | 06/09/2010 | 26/05/2010 | Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Artritis Idiopática Juvenil de evolución poliarticular (AIJ poli) / Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 6 | EUCTR2010-019094-15-SI (EUCTR) | 17/08/2010 | 22/06/2010 | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 7 | EUCTR2010-019094-15-IT (EUCTR) | 12/07/2010 | 27/05/2010 | A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36 | A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36 | polyarticular course Juvenile Idiopathic Arthritis in ethe following forms: - RF positive and negative polyarthritis - systemic arthritis without systemic features - extended oligoarthritis MedDRA version: 12.1;Level: LLT;Classification code 10036036;Term: Polyarticular JCA | Product Code: Givinostat INN or Proposed INN: Givinostat | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy | |||
| 8 | EUCTR2010-019094-15-CZ (EUCTR) | 01/07/2010 | 17/05/2010 | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Czech Republic;Slovenia;Spain;Italy |