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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000872-18-BE

Enrollment

108

Registered

2008-01-29

Start date

2008-04-15

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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 treatme	—

Measure

Time frame

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 treatme

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Secondary

Measure	Time frame
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 ] ;Timepoint(s) of evaluation of this end point: week 12 / week 260	—

Measure

Time frame

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 ] ;Timepoint(s) of evaluation of this end point: week 12 / week 260

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Countries

Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026