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NCT00889863 · OUTCOME

Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) · Source last updated 2012-10-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Days
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 32

What was measured

Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (\<10mg/L) C-Reactive Protein

Analysis population: Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP.

Groups in this outcome

Canakinumab

In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Canakinumab63

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab20.48.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.7
        value
        20.4
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (\<10mg/L) C-Reactive Protein
dispersion Type
Standard Deviation
groups
  1. description
    In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
    id
    OG000
    title
    Canakinumab
param Type
MEAN
population Description
Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP.
reporting Status
POSTED
time Frame
Baseline, Week 32
title
Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein
type
SECONDARY
unit Of Measure
Days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice