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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 July 2017
Main ID:  EUCTR2012-003490-26-ES
Date of registration: 26/06/2013
Prospective Registration: Yes
Primary sponsor: F. Hoffmann-La Roche Ltd
Public title: A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis
Scientific title: 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
Date of first enrolment: 26/06/2013
Target sample size: 48
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003490-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase:  Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Brazil Canada France Germany Italy Mexico
Russian Federation Spain 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:
- Children 1-17 years of age
- Diagnosis systemic juvenile idiopathic arthritis
- Inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids
- Concurrent treatment with DMARDs (including methotrexate [MTX]), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator.
- Discontinuation of biologic agents (other than tocilizumab if the patient is receiving IV TCZ) for 4 days to 20 weeks prior to baseline depending on biologic agent
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
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:
- Prior discontinuation of IV TCZ because of inadequate clinical response or safety events
- Patients with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
- sJIA that is well controlled by any treatment agent other than TCZ (JADAS-71?3.8 with no fever)
- Patients who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA


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

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-

Primary Outcome(s)
Secondary Objective: Secondary objectives:
- To evaluate the pharmacodynamics of SC TCZ in patients with sJIA
- To evaluate the safety of SC TCZ in patients with sJIA

Exploratory Objective
To describe the efficacy of SC TCZ in patients with sJIA
Primary end point(s): Serum TCZ concentration and population PK model-predicted PK exposures (AUC, Cmax and Cmin) for the QW and Q10D dosing regimens at steady state
Main Objective: Primary Objective
- To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA
Timepoint(s) of evaluation of this end point: Fixed timepoints during the first 14 weeks of the study
Secondary Outcome(s)
Secondary end point(s): Secondary endpoints:
- Serum IL-6 and soluble IL-6R (sIL-6R) levels, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR)
- The incidence and severity of adverse events (including local injection-site reactions) and serious adverse events
- The incidence and severity of adverse events of special interest
- The incidence and severity of clinical laboratory abnormalities
- The incidence of anti-TCZ antibodies

Exploratory endpoints:
- Juvenile Arthritis Disease Activity Score (JADAS)-71
- Inactive disease and clinical remission
- Childhood Health Assessment Questionnaire (CHAQ)
Timepoint(s) of evaluation of this end point: Secondary endpoints:
- Pharmacodynamic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14]
- Adverse events, adverse events of special interest and clinical laboratory abnormalities will be recorded for the entire duration of the study [Weeks 0-52]
- The presence of anti-TCZ antibodies will be evaluated at baseline and at regular intervals with event-driven testing in cases of anaphylaxis, serious hypersensitivity events, or any hypersensitivity event (including non-serious events) leading to treatment withdrawal (at the time of the event and at least 6 weeks after the event)

Exploratory endpoints:
- All endpoints will be measured for the duration of the study [Weeks 0-52]
Secondary ID(s)
WA28118
2012-003490-26-DE
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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