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 | EUCTR2012-003486-18-PL (EUCTR) | 19/08/2013 | 02/07/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course 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 POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) 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: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Australia;Peru;Germany | ||
| 2 | EUCTR2012-003490-26-DE (EUCTR) | 08/08/2013 | 05/06/2013 | 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 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2012-003486-18-DE (EUCTR) | 08/08/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course 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 POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0;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 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany;United States;Spain;Russian Federation;United Kingdom;Italy | ||
| 4 | EUCTR2012-003486-18-ES (EUCTR) | 28/06/2013 | 26/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course 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 POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 16.0;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 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany | ||
| 5 | EUCTR2012-003490-26-ES (EUCTR) | 26/06/2013 | 26/06/2013 | 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: 16.0;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 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2012-003486-18-GB (EUCTR) | 14/06/2013 | 20/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course 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 POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0;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 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany | ||
| 7 | EUCTR2012-003490-26-GB (EUCTR) | 14/06/2013 | 20/06/2013 | 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 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2012-003486-18-IT (EUCTR) | 11/06/2013 | 05/06/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course 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 POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) 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: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany | ||
| 9 | EUCTR2012-003490-26-IT (EUCTR) | 11/06/2013 | 05/06/2013 | 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: 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: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 1 | France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2011-001097-25-DE (EUCTR) | 19/10/2011 | 21/09/2011 | Tocilizumab i.v. monthly in patients with pcJIA | Long-term, interventional, open label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Germany who completed the global, multinational trial (WA19977) | Polyarticular-course juvenile idiopathic arthritis MedDRA version: 14.1;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: Ro-Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Pharma AG | NULL | Not Recruiting | Female: no Male: no | Germany | ||||
| 11 | 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 | |||
| 12 | 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 | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Norway;Germany;United Kingdom;Italy;Sweden | ||
| 13 | EUCTR2007-000872-18-DK (EUCTR) | 27/06/2008 | 05/03/2008 | 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 Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA Other descriptive name: 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 | |||
| 14 | EUCTR2007-000872-18-SK (EUCTR) | 09/06/2008 | 09/04/2008 | A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab | A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto 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: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA | 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 | |||
| 15 | 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 | |||
| 16 | EUCTR2007-000872-18-IT (EUCTR) | 12/05/2008 | 23/03/2009 | 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 - ND | 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 - ND | Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis | Product Name: ACTEMRA Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 108 | Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 17 | 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 | |||
| 18 | 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 | |||
| 19 | EUCTR2012-003490-26-Outside-EU/EEA (EUCTR) | 22/08/2013 | 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: 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: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 48 | Phase 1 | Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico | |||
| 20 | EUCTR2012-003486-18-Outside-EU/EEA (EUCTR) | 22/08/2013 | A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course 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 POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS | Polyarticular-course juvenile idiopathic arthritis (pcJIA) 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: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | NA | Female: yes Male: yes | 48 | Phase 1 | Peru;Poland;Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy |