ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab

Conditions

• Systemic Juvenile Idiopathic Arthritis (SJIA)

Eligibility Criteria

Sex

ALL

Age

2 Years - 20 Years

Healthy Volunteers

Not accepted

Interventions

• ACZ885 150 mg (Canakinumab) — DRUG
  Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Study Details

The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

Key Dates

Start date

Nov 17, 2014

Status verified

Jun 2019

Primary completion

Oct 14, 2016

Completion

Sep 25, 2017

Study Design

Enrollment

182 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab Dose Reduction
  All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab was administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continued to maintain inactive disease for 24 additional weeks, canakinumab was administered at 1mg/kg every 4 weeks. If the patient continued to maintain inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
• Experimental: Canakinumab Dose Interval Prolongation
  All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.

Primary Outcome Measure

Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. [ Time Frame: baseline to 24 weeks ]

Locations (2)

Find similar trials in Los Angeles, CA

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