107. 若年性特発性関節炎[全身型若年性特発性関節炎(~2018.3)]
[臨床試験数:151,薬物数:75(DrugBank:13),標的遺伝子数:16,標的パスウェイ数:90

Searched query = "Juvenile idiopathic arthritis", "Systemic juvenile idiopathic arthritis", "Systemic-onset juvenile idiopathic arthritis", "JIA", "SJIA"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
24 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-000435-33-BE
(EUCTR)
12/08/201519/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;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
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Spain;Belgium;Russian Federation;Germany;Italy;United Kingdom
2EUCTR2015-000435-33-DE
(EUCTR)
07/08/201510/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;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
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
3EUCTR2015-000435-33-HU
(EUCTR)
27/07/201510/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) 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
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
4EUCTR2015-000435-33-PL
(EUCTR)
07/07/201503/07/2015A study to assess the pharmacokinetics and safety of tocilizumab inpatients less than 2 years old with Active Systemic Juvenile IdiopathicArthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 19.0;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
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Belgium;Spain;Poland;Russian Federation;Germany;Italy;United Kingdom
5EUCTR2015-000435-33-ES
(EUCTR)
26/06/201529/06/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) 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
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Roche Farma S.A en nombre de F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
10Phase 1France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02165345
(ClinicalTrials.gov)
July 16, 201413/6/2014Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic ArthritisLong-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLActive, not recruiting2 Years18 YearsAll82Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
7EUCTR2013-005212-98-IT
(EUCTR)
09/07/201420/05/2014Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA); 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]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
8EUCTR2013-005212-98-DE
(EUCTR)
30/06/201419/05/2014Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic ArthritisLONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0;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: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
104Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
9EUCTR2013-005212-98-ES
(EUCTR)
16/06/201409/06/2014Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA); 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: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Roche Farma S.A. en nombre de F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
10EUCTR2013-005212-98-GB
(EUCTR)
21/05/201420/05/2014Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 21.0;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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
104Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-003490-26-DE
(EUCTR)
08/08/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
12EUCTR2012-003490-26-ES
(EUCTR)
26/06/201326/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
13EUCTR2012-000444-10-IT
(EUCTR)
22/01/201311/01/2013A STUDY TO LOOK AT LESS FREQUENT DOSING IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO HAVE EXPERIENCED A LABORATORY ABNORMALITY DURING TREATMENT WITH TOCILIZUMABA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Mexico;Canada;Spain;Australia;Germany;United Kingdom;Italy;Sweden
14EUCTR2012-000444-10-DE
(EUCTR)
30/11/201228/09/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0;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
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
43Phase 4Sweden;Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom
15EUCTR2012-000444-10-ES
(EUCTR)
22/11/201214/09/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 15.0;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
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
20Phase 4Mexico;Canada;Spain;Australia;Germany;Norway;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-000444-10-SE
(EUCTR)
01/11/201204/10/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0;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
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
43Phase 4Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;United Kingdom;Italy;Sweden
17NCT01455701
(ClinicalTrials.gov)
October 26, 201218/10/2011A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)Juvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompletedN/A24 MonthsAll11Phase 1United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;United Kingdom
18EUCTR2007-000872-18-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
19EUCTR2007-000872-18-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
20NCT00642460
(ClinicalTrials.gov)
May 200819/3/2008A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of TocilizumabJuvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroidsHoffmann-La RocheNULLCompleted2 Years17 YearsAll112Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2007-000872-18-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
22EUCTR2015-000435-33-FR
(EUCTR)
24/07/2015A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA) 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
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
10Phase 1United States;France;Hungary;Canada;Argentina;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
23EUCTR2012-000444-10-NO
(EUCTR)
27/09/2012A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumabA PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB 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]
Trade Name: RoActemra
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
20Phase 4Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden
24EUCTR2013-005212-98-FR
(EUCTR)
17/06/2015Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS Polyarticular-course juvenile idiopathic arthritis (pcJIA); 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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
96Phase 1United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany