Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01029652 · OUTCOME

High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study · Source last updated 2014-01-30

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

Measure
LEAST_SQUARES_MEAN
Unit
mg/L
Interval / dispersion
95% Confidence Interval
Time frame
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

What was measured

High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.

Analysis population: The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.

Groups in this outcome

Canakinumab 150 mg

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

Triamcinolone Acetonide 40 mg

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.

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

Analysis denominator · Participants

GroupSource count
Canakinumab 150 mg113
Triamcinolone Acetonide 40 mg115

Reported measurements

hsCRP : Core(n= 109, 107)
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg4.50Not reported3.965.12Not reported
Triamcinolone Acetonide 40 mg7.08Not reported6.228.07Not reported
SAA protein : Core (n=105, 106)
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg6.77Not reported5.578.21Not reported
Triamcinolone Acetonide 40 mg17.00Not reported14.0120.62Not reported
hsCRP : 24 weeks(n= 31, 32)
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg5.18Not reported3.797.09Not reported
Triamcinolone Acetonide 40 mg7.18Not reported5.279.77Not reported
SAA protein : 24 weeks (n=28, 33)
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg11.43Not reported7.7616.84Not reported
Triamcinolone Acetonide 40 mg21.11Not reported14.7830.16Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.96
        upper Limit
        5.12
        value
        4.50
      2. group Id
        OG001
        lower Limit
        6.22
        upper Limit
        8.07
        value
        7.08
    title
    hsCRP : Core(n= 109, 107)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.57
        upper Limit
        8.21
        value
        6.77
      2. group Id
        OG001
        lower Limit
        14.01
        upper Limit
        20.62
        value
        17.00
    title
    SAA protein : Core (n=105, 106)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.79
        upper Limit
        7.09
        value
        5.18
      2. group Id
        OG001
        lower Limit
        5.27
        upper Limit
        9.77
        value
        7.18
    title
    hsCRP : 24 weeks(n= 31, 32)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.76
        upper Limit
        16.84
        value
        11.43
      2. group Id
        OG001
        lower Limit
        14.78
        upper Limit
        30.16
        value
        21.11
    title
    SAA protein : 24 weeks (n=28, 33)
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      115
    units
    Participants
description
High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
    id
    OG000
    title
    Canakinumab 150 mg
  2. description
    Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
    id
    OG001
    title
    Triamcinolone Acetonide 40 mg
param Type
LEAST_SQUARES_MEAN
population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.
reporting Status
POSTED
time Frame
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
title
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall
type
SECONDARY
unit Of Measure
mg/L

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

Preserved source evidence · Not medical advice