NCT00889863 · OUTCOME

Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: Baseline, 32 Weeks

What was measured

Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following: * improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables 1. Physician's global assessment of disease activity 2. CHAQ-patient's overall well-being 3. CHAQ-Functional ability 4. \# of joints with active arthritis 5. \# of joints with limitation of motion 6. C-Reactive Protein. * no intermittent fever in the preceding week * no more than one of the first 6 response variables worsening by more than 30%

Analysis population: Participants from the full analysis set with an assessment at the given time-point.

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

Group	Source count
Canakinumab	175

Reported measurements

Non-Responders

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	22.9	Not reported	Not reported	Not reported	Not reported

ACR 30 Response

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	77.1	Not reported	Not reported	Not reported	Not reported

ACR 50 Response

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	73.1	Not reported	Not reported	Not reported	Not reported

ACR 70 Response

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	64.6	Not reported	Not reported	Not reported	Not reported

ACR 90 Response

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	51.4	Not reported	Not reported	Not reported	Not reported

ACR 100 Response

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	34.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
22.9
title
Non-Responders
categories
measurements
group Id
OG000
value
77.1
title
ACR 30 Response
categories
measurements
group Id
OG000
value
73.1
title
ACR 50 Response
categories
measurements
group Id
OG000
value
64.6
title
ACR 70 Response
categories
measurements
group Id
OG000
value
51.4
title
ACR 90 Response
categories
measurements
group Id
OG000
value
34.3
title
ACR 100 Response

denoms

counts
group Id
OG000
value
175
units
Participants

description

groups

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

NUMBER

population Description

Participants from the full analysis set with an assessment at the given time-point.

reporting Status

POSTED

time Frame

Baseline, 32 Weeks

title

Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice