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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 17 August 2015
Main ID:  EUCTR2007-000872-18-BE
Date of registration: 29/01/2008
Prospective Registration: Yes
Primary sponsor: F. Hoffmann-La Roche Ltd.
Public title: The 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.
Scientific title: 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
Date of first enrolment: 15/04/2008
Target sample size: 108
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000872-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Argentina Australia Belgium Brazil Canada Czech Republic Denmark Germany
Greece Italy Mexico Netherlands Norway Poland Slovakia Spain
Sweden United Kingdom United States
Contacts
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd.
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
• patients aged 2 - 17 years of age;
• systemic JIA with >= 6 months persistent activity;
• presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids);
• inadequate clinical response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• wheelchair bound or bed-ridden;
• any other autoimmune, rheumatic disease or overlap syndrome other than sJIA;
• intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study;
• DMARDs (other than methotrexate);
• previous treatment with tocilizumab.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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]
Intervention(s)

Trade Name: RoActemra
Product Name: RoActemra
Product Code: RO4877533 (TCZ)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Timepoint(s) of evaluation of this end point: week 12
Main Objective: Part I: Primary Objectives:
1. To assess the efficacy of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to signs and symptoms in sJIA patients with persistent activity and an inadequate response to NSAIDs and systemic corticosteroids.
2. To evaluate the short term safety of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to adverse events and laboratory assessments in patients with sJIA with persistent activity and an inadequate response to NSAIDs and corticosteroids.
Part II: Primary Objectives:
1. To evaluate the safety of tocilizumab in chronic administration;
2. To assess the effect of tocilizumab to enable the reduction or elimination of corticosteroids
Part III: Primary Objectives
1. To assess the long-term safety of 8 mg/kg tocilizumab in children > 30 kg and 12 mg/kg tocilizumab in children < 30 kg with regard to adverse events and laboratory result abnormalities;
Primary end point(s): Primary endpoint:
The proportion of patients with at least 30% improvement in JIA
core set (JIA ACR30 response) at week 12 (JIA Core Set assessed
in comparison to baseline) and absence of fever*
*Absence of fever is defined as no temperature measurement = 37.5° C.
in the preceding seven days
Secondary Objective: Part I
1. To assess the efficacy of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to common systemic features in sJIA patients with persistent activity and an inadequate response to NSAIDs and corticosteroids;
2. To assess the efficacy of treatment with tocilizumab to permit concomitant corticosteroid reduction;
Part II
1. To assess the durability and magnitude of the tocilizumab efficacy response in patients with sJIA including meeting the definition of inactive disease and clinical remission;
2. To assess the efficacy of treatment with tocilizumab to permit concomitant medication reductions;
Part III:
1. To assess the efficacy of treatment with tocilizumab to permit concomitant medication reductions (corticosteroids, methotrexate, NSAIDs);

Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: week 12 / week 260
Secondary end point(s): Proportion of patients with JIA core set ACR 30/50/70/90 response [ Time Frame: Week 12 ]
Mean percent change in JIA core set ACR score [ Time Frame: Week 12 ]
Proportion of patients with fever [ Time Frame: Week 12 ]
Change in laboratory indicators (hsCRP, Hb, platelets, leukocytes) [ Time Frame: Week 12 ]
Concomitant corticosteroid reduction [ Time Frame: Week 12 ]
Immunogenicity: anti-tocilizumab antibodies (HAHA) [ Time Frame: 260 weeks ]
Pharmacokinetics/Pharmacodynamics: tocilizumab, Interleukin-6 (IL-6), sIL-6R [ Time Frame: 260 weeks ]
Concomitant medication reduction (corticosteroids, methotrexate, NSAIDs) [ Time Frame: 260 weeks ]
Duration of response (inactive disease, clinical remission) [ Time Frame: 260 weeks ]

Secondary ID(s)
WA18221
NCT00642460
Source(s) of Monetary Support
F. Hoffmann-La Roche Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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