An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Conditions

• Systemic Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

2 Years - 20 Years

Healthy Volunteers

Not accepted

Interventions

• ACZ885 — DRUG
• Canakinumab — DRUG
• Canakinumab — DRUG
  Patients rolling over into this study from CACZ885G2301E1 (Cohort 1) will continue on their established canakinumab dose of either 4 mg/kg SC given every 4 weeks or 2mg/kg SC given every 4 weeks, until eligible for dose reduction. Canakinumab-naïve patients
• Canakinumab — DRUG
  Patients rolling over into this study from CACZ885G2301E1(Cohort 2) will receive a standard canakinumab dose of 4mg/kg SC given every 4 weeks, until eligible for dose reduction

Study Details

This two-part open-label, multi-arm, non-comparative study will collect long-term safety, efficacy and tolerability data from patients who were responsive to canakinumab from study CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort 2). In addition, the effect of inactivated vaccines in an SJIA patient population will be assessed for the development of adequate (protective) antibody levels following immunization according to respective local vaccination guidelines. Study Part I: All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4 weeks for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end unless discontinuation occurs, or until they qualify for Part II of the study. Study Part II: Patients who are eligible will be randomized to receive canakinumab at a reduced dose or prolonged dose interval (see requirements for dose reduction/dose interval prolongation below). Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but will be part of the treatment arm canakinumab dose reduction if they are eligible.

Key Dates

Start date

Jan 31, 2013

Status verified

Oct 2015

Primary completion

Jan 31, 2015

Completion

Jan 31, 2015

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab - Cohort 1, 2mg
  2 mg/kg q4wk (followed by taper to 1 mg/kg q4wk and drug discontinuation if appropriate)
• Experimental: Canakinumab - Cohort 1, 4mg
  4 mg/kg q8wk (followed by taper to 4 mg/kg q12wk and drug discontinuation if appropriate)
• Experimental: Canakinumab - Cohort 2, 2mg
  2 mg/kg q4wk (followed by taper to 1 mg/kg q4wk and drug discontinuation if appropriate)
• Experimental: Canakinumab - Cohort 2, 4mg
  4 mg/kg q8wk (followed by taper to 4 mg/kg q12wk and drug discontinuation if appropriate)
• Experimental: Cohort 2 - canakinumab dose reduction
• Experimental: Cohort 1 - canakinumab dose reduction

Primary Outcome Measure

Long-term safety and tolerability of canakinumab and the retention rate of canakinumab-treated patients [ Time Frame: Days 1 to 533 ]