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NCT01080131 · OUTCOME

High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels

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 Colchicines Including a 12 Week Extension and a 1 Year Open-label 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 after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

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. Analyses 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: For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. "N" indicates the number of participants with available data in each analysis.

Groups in this outcome

Canakinumab 150 mg

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Triamcinolone Acetonide 40 mg

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

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 mg112
Triamcinolone Acetonide 40 mg114

Reported measurements

Baseline flare: hsCRP [N=107, 110]
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg3.84Not reported3.264.53Not reported
Triamcinolone Acetonide 40 mg6.38Not reported5.437.50Not reported
Baseline flare: SAA [N=95, 104]
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg6.31Not reported4.958.04Not reported
Triamcinolone Acetonide 40 mg15.85Not reported12.5819.98Not reported
Last post-baseline flare: hsCRP [N= 22, 42]
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg3.69Not reported2.445.60Not reported
Triamcinolone Acetonide 40 mg4.32Not reported3.235.60Not reported
Last post-baseline flare: SAA, [N= 19, 39]
Values in mg/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg6.74Not reported3.5612.78Not reported
Triamcinolone Acetonide 40 mg11.04Not reported7.1717.02Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.26
        upper Limit
        4.53
        value
        3.84
      2. group Id
        OG001
        lower Limit
        5.43
        upper Limit
        7.50
        value
        6.38
    title
    Baseline flare: hsCRP [N=107, 110]
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.95
        upper Limit
        8.04
        value
        6.31
      2. group Id
        OG001
        lower Limit
        12.58
        upper Limit
        19.98
        value
        15.85
    title
    Baseline flare: SAA [N=95, 104]
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.44
        upper Limit
        5.60
        value
        3.69
      2. group Id
        OG001
        lower Limit
        3.23
        upper Limit
        5.60
        value
        4.32
    title
    Last post-baseline flare: hsCRP [N= 22, 42]
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.56
        upper Limit
        12.78
        value
        6.74
      2. group Id
        OG001
        lower Limit
        7.17
        upper Limit
        17.02
        value
        11.04
    title
    Last post-baseline flare: SAA, [N= 19, 39]
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      114
    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. Analyses 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
    Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
    id
    OG000
    title
    Canakinumab 150 mg
  2. description
    Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
    id
    OG001
    title
    Triamcinolone Acetonide 40 mg
param Type
LEAST_SQUARES_MEAN
population Description
For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. "N" indicates the number of participants with available data in each analysis.
reporting Status
POSTED
time Frame
72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
title
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels
type
SECONDARY
unit Of Measure
mg/L

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Preserved source evidence · Not medical advice