Tocilizumab roche (DrugBank: Tocilizumab)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 2 |
| 107 | 若年性特発性関節炎［全身型若年性特発性関節炎（~2018.3）］ | 5 |
| 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 | EUCTR2008-000587-17-ES (EUCTR) | 22/07/2008 | 26/05/2008 | Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy | Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy | Artritis reumatoideRheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 2 | EUCTR2004-003733-14-DK (EUCTR) | 26/01/2005 | 07/12/2004 | A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis. | A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis. | Rheumatoid arthritis | Trade Name: RoActemra® Product Name: Tocilizumab Roche Product Code: RO4877533 INN or Proposed INN: Tocilizumab Roche Other descriptive name: MRA, Actemra | F Hoffmann La-Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1170 | Finland;Spain;Denmark;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 | |||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 |