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NCT01080131 · OUTCOME

Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab

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
MEAN
Unit
mg/L
Interval / dispersion
Standard Deviation
Time frame
24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

What was measured

Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Analysis population: Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

Groups in this outcome

Re-treated With Canakinumab 150 mg

Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.

Triam Switched to Canakinumab

Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.

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

Analysis denominator · Participants

GroupSource count
Re-treated With Canakinumab 150 mg62
Triam Switched to Canakinumab41

Reported measurements

24-hours post-dose [N=47, 36]
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Re-treated With Canakinumab 150 mg129.0324.45Not reportedNot reportedNot reported
Triam Switched to Canakinumab145.9257.44Not reportedNot reportedNot reported
72-hours post-dose [N=54, 37]
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Re-treated With Canakinumab 150 mg45.6163.45Not reportedNot reportedNot reported
Triam Switched to Canakinumab45.497.00Not reportedNot reportedNot reported
7 days post-dose [N=56, 39]
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Re-treated With Canakinumab 150 mg5.78.90Not reportedNot reportedNot reported
Triam Switched to Canakinumab5.98.34Not reportedNot reportedNot reported
4 weeks post-dose [N=47, 37]
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Re-treated With Canakinumab 150 mg3.43.67Not reportedNot reportedNot reported
Triam Switched to Canakinumab5.07.02Not reportedNot reportedNot reported
8 weeks post-dose [N=38, 35]
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Re-treated With Canakinumab 150 mg3.54.24Not reportedNot reportedNot reported
Triam Switched to Canakinumab5.313.41Not reportedNot reportedNot reported
12 weeks post-dose [N=38, 29]
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Re-treated With Canakinumab 150 mg3.42.37Not reportedNot reportedNot reported
Triam Switched to Canakinumab4.85.94Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        324.45
        value
        129.0
      2. group Id
        OG001
        spread
        257.44
        value
        145.9
    title
    24-hours post-dose [N=47, 36]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        163.45
        value
        45.6
      2. group Id
        OG001
        spread
        97.00
        value
        45.4
    title
    72-hours post-dose [N=54, 37]
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.90
        value
        5.7
      2. group Id
        OG001
        spread
        8.34
        value
        5.9
    title
    7 days post-dose [N=56, 39]
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.67
        value
        3.4
      2. group Id
        OG001
        spread
        7.02
        value
        5.0
    title
    4 weeks post-dose [N=47, 37]
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.24
        value
        3.5
      2. group Id
        OG001
        spread
        13.41
        value
        5.3
    title
    8 weeks post-dose [N=38, 35]
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.37
        value
        3.4
      2. group Id
        OG001
        spread
        5.94
        value
        4.8
    title
    12 weeks post-dose [N=38, 29]
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      41
    units
    Participants
description
Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
dispersion Type
Standard Deviation
groups
  1. description
    Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
    id
    OG000
    title
    Re-treated With Canakinumab 150 mg
  2. description
    Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
    id
    OG001
    title
    Triam Switched to Canakinumab
param Type
MEAN
population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
reporting Status
POSTED
time Frame
24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
title
Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab
type
SECONDARY
unit Of Measure
mg/L

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

Preserved source evidence · Not medical advice