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NCT01029652 · OUTCOME

Serum Amyloid A Protein (SAA) Levels for Patients 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 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
MEAN
Unit
mg/L
Interval / dispersion
Standard Deviation
Time frame
24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

What was measured

Serum Amyloid A Protein (SAA) levels 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 treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

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

Groups in this outcome

Randomized to Canakinumab and Re-treated With Canakinumab

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.

Randomized to Triamcinolone and Switched to Canakinumab

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 week extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period

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

Analysis denominator · Participants

GroupSource count
Randomized to Canakinumab and Re-treated With Canakinumab69
Randomized to Triamcinolone and Switched to Canakinumab39

Reported measurements

24 hours post dose (n= 45, 27)
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab151.4310.09Not reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab86.5188.46Not reportedNot reportedNot reported
72 hours post dose (n=45, 36)
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab42.5116.89Not reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab26.973.37Not reportedNot reportedNot reported
7 days post dose (n=67, 39)
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab5.48.83Not reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab4.96.56Not reportedNot reportedNot reported
4 weeks post dose (n=52, 35)
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab31.0193.64Not reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab8.519.75Not reportedNot reportedNot reported
8 weeks post dose (n=45, 37)
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab4.24.26Not reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab5.48.36Not reportedNot reportedNot reported
12 weeks post dose (n=42, 33)
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab10.724.62Not reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab7.822.98Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        310.09
        value
        151.4
      2. group Id
        OG001
        spread
        188.46
        value
        86.5
    title
    24 hours post dose (n= 45, 27)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        116.89
        value
        42.5
      2. group Id
        OG001
        spread
        73.37
        value
        26.9
    title
    72 hours post dose (n=45, 36)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.83
        value
        5.4
      2. group Id
        OG001
        spread
        6.56
        value
        4.9
    title
    7 days post dose (n=67, 39)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        193.64
        value
        31.0
      2. group Id
        OG001
        spread
        19.75
        value
        8.5
    title
    4 weeks post dose (n=52, 35)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.26
        value
        4.2
      2. group Id
        OG001
        spread
        8.36
        value
        5.4
    title
    8 weeks post dose (n=45, 37)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.62
        value
        10.7
      2. group Id
        OG001
        spread
        22.98
        value
        7.8
    title
    12 weeks post dose (n=42, 33)
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Serum Amyloid A Protein (SAA) levels 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 treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
dispersion Type
Standard Deviation
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
    Randomized to Canakinumab and Re-treated With Canakinumab
  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 week extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
    id
    OG001
    title
    Randomized to Triamcinolone and Switched to Canakinumab
param Type
MEAN
population Description
Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 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 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)
title
Serum Amyloid A Protein (SAA) Levels for Patients 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