Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Ages 1 (10 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
Exclusion criteria
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with pcJIA.;Secondary Objective: Secondary Objectives - To evaluate the pharmacodynamics of SC TCZ in patients with pcJIA - To evaluate the safety of SC TCZ in patients with pcJIA Exploratory Objective - To describe the efficacy of SC TCZ in patients with pcJIA ;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 ;Timepoint(s) of evaluation of this end point: Fixed timepoints during the first 14 weeks of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Explolatory 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] | — |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Italy, Peru, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed