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NCT01029652 · OUTCOME

Physician's Assessment of Erythema for Patients Re-treated 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

What was measured

The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. 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. After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization 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

Absent (72 hours post dose) (n=61, 35)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab82.0Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab80.0Not reportedNot reportedNot reportedNot reported
Present (72 hours post dose) (n=61, 35)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab18.0Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab20.0Not reportedNot reportedNot reportedNot reported
Absent (7 days post dose) (n=67, 36)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab95.5Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab94.4Not reportedNot reportedNot reportedNot reported
Present (7 days post dose) (n=67, 36)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Randomized to Canakinumab and Re-treated With Canakinumab4.5Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone and Switched to Canakinumab5.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        82.0
      2. group Id
        OG001
        value
        80.0
    title
    Absent (72 hours post dose) (n=61, 35)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18.0
      2. group Id
        OG001
        value
        20.0
    title
    Present (72 hours post dose) (n=61, 35)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        95.5
      2. group Id
        OG001
        value
        94.4
    title
    Absent (7 days post dose) (n=67, 36)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.5
      2. group Id
        OG001
        value
        5.6
    title
    Present (7 days post dose) (n=67, 36)
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      39
    units
    Participants
description
The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. 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.
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. After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization 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
NUMBER
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
72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
title
Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice