107. 若年性特発性関節炎 Juvenile idiopathic arthritis Clinical trials / Disease details


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142

  
78 trials found
No.TrialIDDate_
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1NCT03301883
(ClinicalTrials.gov)
April 26, 201821/9/2017A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: Tocilizumab;Drug: NSAIDs;Drug: CSs;Drug: MTXHoffmann-La RocheNULLActive, not recruiting2 Years17 YearsAll74Phase 4China
2ChiCTR-OPB-17013704
2017-12-202017-12-05A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritisA phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis systemic juvenile idiopathic arthritisCase series:Tocilizumab;Children's Hospital of Chongqing Medical UniversityNULLRecruiting217BothCase series:65;Phase 4China
3ChiCTR-INR-17011829
2017-08-012017-07-02Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumabMultiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab Systemic onset juvenile idiopathic arthritisCase:Tocilizumab;Control:Conventional Treatment;Shenzhen Children's HospitalNULLPendingBothCase:75;Control:75;China
4NCT02840175
(ClinicalTrials.gov)
May 18, 201719/7/2016Treatment Tapering in JIA With Inactive DiseaseTreatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic TherapyJuvenile Idiopathic ArthritisDrug: etanercept;Drug: adalimumab;Drug: Abatacept;Drug: TocilizumabAssistance Publique - Hôpitaux de ParisNULLCompleted2 Years17 YearsAll62Phase 3France
5JPRN-UMIN000024178
2016/09/2828/09/2016Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis Systemic-onset juvenile idiopathic arthritis(sJIA)Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeksYokohama City University Hospital Department of PediatricsNULLRecruiting2years-oldNot applicableMale and Female5Not selectedJapan
6ChiCTR-OPC-17011391
2016-09-012017-05-12The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in ChinaThe efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China systemic juvenile idiopathic arthritistocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid;Children's Hospital of Chongqing Medical UniversityNULLCompleted216Bothtocilizumab group:36;glucocorticoid group:24;China
7EUCTR2016-000312-15-FR
(EUCTR)
12/08/201617/06/2016Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREMTreatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology.
MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: ENBREL
Product Name: ENBREL
INN or Proposed INN: Etanercept
Other descriptive name: Etanercept
Trade Name: HUMIRA
Product Name: HUMIRA
INN or Proposed INN: adalimumab
Other descriptive name: adalimumab
Trade Name: ROACTEMRA
Product Name: ROACTEMRA
INN or Proposed INN: tocilizumab
Other descriptive name: tocilizumab
Trade Name: ORENCIA
Product Name: ORENCIA
INN or Proposed INN: abatacept
Other descriptive name: abatacept
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
230Phase 3France
8EUCTR2015-000435-33-GB
(EUCTR)
18/08/201517/07/2015A 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 Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
9EUCTR2015-000435-33-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
10EUCTR2015-000435-33-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 1United Kingdom;Italy;Germany;Russian Federation;Spain;Belgium;Poland;Hungary;France
11EUCTR2015-000435-33-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
12EUCTR2015-000435-33-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
13EUCTR2015-001323-23-GB
(EUCTR)
03/07/201501/05/2015A study of Tocilizumab in patients with JIA associated Uveitis who have not responded to treatment with an anti-TNF. A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis. - APTITUDE Juvenile Idiopathic Arthritis with Associated Uveitis
MedDRA version: 18.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Tocilizumab
Product Name: Tocilizumab
Product Code: Ro 487-7533/F10
INN or Proposed INN: Tocilizumab
Other descriptive name: RoActemra
University Hospitals Bristol NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
22 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
14EUCTR2015-000435-33-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
15NCT02165345
(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 RocheNULLCompleted2 Years18 YearsAll82Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
16EUCTR2013-005212-98-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 LtdNULLNot RecruitingFemale: yes
Male: yes
96Phase 1United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
17EUCTR2013-005212-98-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 1United States;France;Mexico;Canada;Argentina;Spain;Brazil;Australia;Russian Federation;Germany;United Kingdom;Italy
18EUCTR2013-005212-98-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
19EUCTR2013-005212-98-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]
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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
104 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
20NCT01603355
(ClinicalTrials.gov)
November 201318/5/2012Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated UveitisAn Open-label Trial to Assess the Efficacy and Safety of Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Vision-threatening Uveitis That is Refractory to Other Modes of Systemic ImmunosuppressionJuvenile Idiopathic Arthritis Associated UveitisDrug: TocilizumabEric B. SuhlerGenentech, Inc.Terminated2 Years17 YearsAll3Phase 1/Phase 2United States
21EUCTR2012-003486-18-PL
(EUCTR)
19/08/201302/07/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Australia;Peru;Germany
22NCT01904292
(ClinicalTrials.gov)
August 15, 201314/6/2013A Study of Subcutaneously Administered Tocilizumab in Participants 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 ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted1 Year17 YearsAll52Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
23EUCTR2012-003486-18-DE
(EUCTR)
08/08/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany;United States;Spain;Russian Federation;United Kingdom;Italy
24EUCTR2012-003490-26-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
25NCT01904279
(ClinicalTrials.gov)
July 201314/6/2013A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted1 Year17 YearsAll52Phase 1United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom;Peru;Poland
26EUCTR2012-003486-18-ES
(EUCTR)
28/06/201326/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany
27EUCTR2012-003490-26-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
28EUCTR2012-003490-26-GB
(EUCTR)
14/06/201320/06/2013 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 LtdNULLNot 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): noFrance;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
29EUCTR2012-003486-18-GB
(EUCTR)
14/06/201320/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritisA 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.NULLNot 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): noUnited States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany
30EUCTR2012-003486-18-IT
(EUCTR)
11/06/201305/06/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany
31EUCTR2012-003490-26-IT
(EUCTR)
11/06/201305/06/2013A 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: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
48Phase 1France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;United Kingdom;Italy
32NCT01734382
(ClinicalTrials.gov)
June 10, 201322/11/2012A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis (SJIA) Who Experience Laboratory Abnormalities During Treatment With TocilizumabJuvenile Idiopathic ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted2 Years17 YearsAll35Phase 4United States;Argentina;Canada;Germany;Israel;Italy;Mexico;Russian Federation;Spain;United Kingdom;Australia;Norway;Sweden
33NCT01727986
(ClinicalTrials.gov)
March 20138/11/2012An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 StudyExtension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977)Juvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted9 Years18 YearsBoth11Phase 3Brazil
34EUCTR2012-000444-10-IT
(EUCTR)
22/01/201311/01/2013A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB A 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.NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden
35EUCTR2012-000444-10-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
36EUCTR2012-000444-10-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
37EUCTR2012-000444-10-GB
(EUCTR)
09/11/201221/08/2012A 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: 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]
Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
43 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSweden;United Kingdom;Italy;Germany;Norway;Israel;Russian Federation;Australia;Spain;Canada;Mexico
38EUCTR2012-000444-10-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
39NCT01455701
(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
40NCT01575769
(ClinicalTrials.gov)
March 201210/4/2012An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic ArthritisLong-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From Poland and Russia Who Completed the Global, Multinational Trial (WA19977).Juvenile Idiopathic ArthritisDrug: RoActemra/Actemra (tocilizumab)Hoffmann-La RocheNULLTerminated2 YearsN/AAll41Phase 3Poland;Russian Federation
41NCT01673919
(ClinicalTrials.gov)
February 201223/8/2012A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core StudyLong-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)Juvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted4 YearsN/AAll7Phase 3France
42NCT01667471
(ClinicalTrials.gov)
January 201215/8/2012A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core StudyLong-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global, Multinational Trial (WA19977)Juvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted9 Years18 YearsAll6Phase 3Germany
43EUCTR2011-001097-25-DE
(EUCTR)
19/10/201121/09/2011Tocilizumab i.v. monthly in patients with pcJIALong-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 AGNULLNot RecruitingFemale: no
Male: no
Germany
44EUCTR2009-011593-15-NL
(EUCTR)
09/02/201030/09/2009A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritisA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis polyarticular-course juvenile idiopathic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: RoActemra
Product Code: Ro 487-7533/F01
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy
45NCT00988221
(ClinicalTrials.gov)
November 30, 20091/10/2009A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic ArthritisA 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisDrug: Tocilizumab;Drug: PlaceboHoffmann-La RocheNULLCompleted2 Years17 YearsAll188Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Netherlands
46EUCTR2009-011593-15-FR
(EUCTR)
12/11/200904/12/2009A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritisA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis polyarticular-course juvenile idiopathic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: RoActemra
Product Code: Ro 487-7533/F01
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy
47EUCTR2009-011593-15-ES
(EUCTR)
27/10/200929/07/2009Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritisEnsayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis Artritis idiopática juvenil activa de curso poliarticular/Polyarticular-course juvenile idiopathic arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185Phase 3France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
48EUCTR2009-011593-15-BE
(EUCTR)
19/10/200923/09/2009A two year study to evaluate the effect of tocilizumab in children who have arthritis in several jointsA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH Polyarticular-course juvenile idiopathic arthritis
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 Code: Ro 487-7533/F01
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
185Phase 3Canada;Argentina;Belgium;Poland;Brazil;Peru;Australia;Netherlands;Germany;Mexico;United States;Spain;Russian Federation;Italy;United Kingdom;France
49EUCTR2009-011593-15-IT
(EUCTR)
11/09/200928/07/2009A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - NDA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - ND Polyarticular-course JIA (pcJIA) consisting of RF-positive, RF-negative, and extended oligoarticular subsets.
MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Trade Name: RoActemra
Trade Name: RoActemra
Trade Name: RoActemra
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185France;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
50EUCTR2009-011593-15-DE
(EUCTR)
08/09/200920/07/2009A two year study to evaluate the effect of tocilizumab in children who have arthritis in several jointsA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH Polyarticular-course juvenile idiopathic arthritis
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 Code: Ro 487-7533/F01
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
185United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;Peru;Germany;Netherlands
51EUCTR2009-011593-15-GB
(EUCTR)
20/08/200906/07/2009 A two year study to evaluate the effect of tocilizumab in children who have arthritis in several jointsA 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH Polyarticular-course juvenile idiopathic arthritis
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 Code: Ro 487-7533/F01
INN or Proposed INN: Tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
185 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany
52NCT00868751
(ClinicalTrials.gov)
March 200924/3/2009Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic ArthritisSingle Patient Use of Tocilizumab for Treatment of Steroid Dependent, Active Systemic Onset Juvenile Idiopathic ArthritisArthritis, Juvenile Rheumatoid;Still's Disease, Juvenile OnsetBiological: tocilizumabTufts Medical CenterHoffmann-La RocheTerminated2 Years16 YearsAll1N/AUnited States
53NCT00862758
(ClinicalTrials.gov)
February 200916/3/2009Request for Single Patient IND for Compassionate/Emergency Use of TocilizumabEmergency IND for Provision of TocilizumabJuvenile Idiopathic ArthritisDrug: TocilizumabUniversity of OklahomaHoffmann-La RocheNo longer available11 Years12 YearsMaleN/AUnited States
54EUCTR2007-000872-18-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
55EUCTR2007-000872-18-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
56EUCTR2007-000872-18-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
57JPRN-UMIN000001457
2008/10/0128/10/2008The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial Adult Still's disease and systemic juvenile idiopathic arthritisTocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weightDivision of Rheumatology & Clinical Immunology, Jichi Medical UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female10Not selectedJapan
58EUCTR2007-000872-18-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
59EUCTR2007-000872-18-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
60JPRN-UMIN000001250
2008/07/0116/07/2008Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial Adult Still's disease or systemic juvenile idiopathic arthritisTocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks.Division of Rheumatology & Clinical Immunology, Jichi Medical UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female10Not selectedJapan
61EUCTR2007-000872-18-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
62EUCTR2007-000872-18-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
63EUCTR2007-000872-18-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
64EUCTR2007-000872-18-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
65NCT00642460
(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
66EUCTR2007-000872-18-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
67EUCTR2007-000872-18-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
68NCT00144625
(ClinicalTrials.gov)
February 20052/9/2005Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JPPolyarticular Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted2 Years19 YearsBoth19Phase 3NULL
69NCT00144664
(ClinicalTrials.gov)
November 20042/9/2005Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIASystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted2 Years19 YearsBoth19Phase 3NULL
70NCT00144612
(ClinicalTrials.gov)
July 20042/9/2005Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JPSystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted2 Years19 YearsBoth60Phase 3NULL
71NCT00144599
(ClinicalTrials.gov)
May 20042/9/2005Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIASystemic Juvenile Idiopathic ArthritisDrug: MRA(Tocilizumab);Drug: placeboChugai PharmaceuticalNULLCompleted2 Years19 YearsBoth56Phase 3NULL
72EUCTR2015-000435-33-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
73EUCTR2007-000872-18-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
74EUCTR2012-003486-18-Outside-EU/EEA
(EUCTR)
22/08/2013A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritisA 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.NULLNAFemale: yes
Male: yes
48Phase 1Peru;Poland;Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy
75JPRN-JapicCTI-050017
02/09/2005Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA) sJIAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion
Chugai Pharmaceutical Co., Ltd.NULL219Phase 3NULL
76EUCTR2013-005212-98-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]
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 LtdNULLNot Recruiting Female: yes
Male: yes
96 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
77EUCTR2012-003490-26-Outside-EU/EEA
(EUCTR)
22/08/2013A 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: 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 LtdNULLNAFemale: yes
Male: yes
48Phase 1Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico
78EUCTR2012-000444-10-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