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

  
12 trials found
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1EUCTR2007-000872-18-NL
(EUCTR)
01/12/200806/03/2008A 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 tocilizumabA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2EUCTR2007-000872-18-CZ
(EUCTR)
16/10/200826/02/2008The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.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, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
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: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
3EUCTR2007-000872-18-GB
(EUCTR)
03/10/200826/08/2009The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.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, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 13.1;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: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
108 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
4EUCTR2007-000872-18-GR
(EUCTR)
09/09/200821/03/2008A 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 tocilizumabA 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.NULLNot RecruitingFemale: yes
Male: yes
108Phase 3Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Norway;Germany;United Kingdom;Italy;Sweden
5EUCTR2007-000872-18-DE
(EUCTR)
11/07/200814/02/2008The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.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, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 14.0;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: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Norway;Sweden
6EUCTR2007-000872-18-DK
(EUCTR)
27/06/200805/03/2008A 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 tocilizumabA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
7EUCTR2007-000872-18-SK
(EUCTR)
09/06/200809/04/2008A 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 tocilizumabA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
8EUCTR2007-000872-18-ES
(EUCTR)
23/05/200826/02/2008Estudio 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 - TENDEREstudio 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2007-000872-18-IT
(EUCTR)
12/05/200823/03/2009A 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 - NDA 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
10EUCTR2007-000872-18-BE
(EUCTR)
15/04/200829/01/2008The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.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, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 13.1;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: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
108United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
11EUCTR2007-000872-18-SE
(EUCTR)
07/04/200805/02/2008A 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 tocilizumabA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
108Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
12EUCTR2007-000872-18-NO
(EUCTR)
20/02/2008A 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 LimitedNULLNAFemale: yes
Male: yes
108Phase 3Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden