A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis

Phase 1

Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 16.0Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Registration Number: EUCTR2012-003490-26-ES

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective<br>- To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA;Secondary Objective: Secondary objectives:<br>- To evaluate the pharmacodynamics of SC TCZ in patients with sJIA <br>- To evaluate the safety of SC TCZ in patients with sJIA <br><br>Exploratory Objective<br>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;Timepoint(s) of evaluation of this end point: Fixed timepoints during the first 14 weeks of the study

Secondary Outcome Measures