A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints

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 - CHERISH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011593-15-GB

Enrollment

185

Registered

2009-07-06

Start date

2009-08-20

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

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

Interventions

Trade Name: RoActemra Product Code: Ro 487-7533/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: children/juveniles, 2-17 years of age polyarticular-course juvenile idiopathic arthritis (pcJIA) > / = 6 months duration active disease (>/= 5 active joints, >/= 3 with limitation of motion) inadequate response to or inability to tolerate methotrexate methotrexate, oral corticosteroids and NSAIDs at stable dose (at least 8, 4 and 2 weeks, respectively) prior to and including baseline biologics discontinued, between at least 1 and 20 weeks prior to and including baseline, depending on biologic 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: auto-immune, rheumatic disease or overlap syndrome other than polyarticular-course JIA wheelchair bound or bedridden intraarticular, intramuscular, intravenous or long-acting corticosteroids within 4 weeks prior to and including baseline DMARDs (other than methotrexate) within 4 weeks prior to and including baseline previous treatment with tocilizumab

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective (from Part II) To compare the proportion of patients on tocilizumab versus placebo who develop a JIA ACR30 flare (compared to week 16) by week 40. ; Primary end point(s): Part II Proportion of patients who develop a JIA ACR30 flare (relative to week 16) in the period from week 16 up to and including week 40. ;Timepoint(s) of evaluation of this end point: First JIA ACR30 flare between visit weeks 16 and 40.; Secondary Objective: • To evaluate the efficacy of open-label tocilizumab therapy (Part I), • To evaluate the long-term effect of tocilizumab on the maintenance of clinical response and safety in patients with pcJIA (Part III) • To evaluate the efficacy and safety of 8 mg/kg vs 10 mg/kg in patients < 30 kg (Parts I, II and III)	—

Measure

Time frame

Main Objective: Primary Objective (from Part II) To compare the proportion of patients on tocilizumab versus placebo who develop a JIA ACR30 flare (compared to week 16) by week 40. ; Primary end point(s): Part II Proportion of patients who develop a JIA ACR30 flare (relative to week 16) in the period from week 16 up to and including week 40. ;Timepoint(s) of evaluation of this end point: First JIA ACR30 flare between visit weeks 16 and 40.; Secondary Objective: • To evaluate the efficacy of open-label tocilizumab therapy (Part I), • To evaluate the long-term effect of tocilizumab on the maintenance of clinical response and safety in patients with pcJIA (Part III) • To evaluate the efficacy and safety of 8 mg/kg vs 10 mg/kg in patients < 30 kg (Parts I, II and III)

—

Secondary

Measure	Time frame
Secondary end point(s): • Proportion of patients with JIA ACR30/50/70/90 responses at week 40. • Mean absolute change from baseline in each component of the JIA core set at week 40. • Mean absolute change from baseline in pain VAS at week 40. • Proportion of patients with inactive disease at week 40. ;Timepoint(s) of evaluation of this end point: Week 40	—

Countries

Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, Spain, 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