A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritis
- Conditions
- Polyarticular-course juvenile idiopathic arthritis (pcJIA)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]MedDRA version: 17.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
- Registration Number
- EUCTR2012-003486-18-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
- Ages 1 (12 for patients in Russia) year up to and including 17 years at screening
- Diagnosis of polyarticular-course juvenile idiopathic arthritis (RF+ or RF- polyarticular JIA or extended oligoarticular JIA)
- Inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate
- Concurrent treatment with DMARDs (including MTX), NSAIDs and oral corticosteroids is permitted
- Discontinuation of any biologic agents (other than tocilizumab if the patient is receiving IV TCZ) for 2-20 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
- 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
- pcJIA that is well controlled by any treatment agent other than TCZ (JADAS-71 = 3.8)
- Patients who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
- Prior stem cell transplant at any time
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Primary Objective<br> - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with pcJIA.<br> ;<br> Secondary Objective: Secondary Objectives<br> - To evaluate the pharmacodynamics of SC TCZ in patients with pcJIA<br> - To evaluate the safety of SC TCZ in patients with pcJIA<br> <br> Exploratory Objective<br> - To describe the efficacy of SC TCZ in patients with pcJIA<br> ;<br> Primary end point(s): - Serum TCZ concentration and population PK model-predicted PK exposures (AUC, Cmax, and Cmin) for the Q2W and Q3W dosing regimens at steady state<br> ;Timepoint(s) of evaluation of this end point: Fixed timepoints during the first 14 weeks of the study
- Secondary Outcome Measures
Name Time Method