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NCT01029652 · OUTCOME

Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
72 weeks overall

What was measured

This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Analysis population: Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.

Groups in this outcome

All Randomized to 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 Canakinumab :Before Re-treated With Canakinumab

All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab

Randomized to Canakinumab :After Re-treated With Canakinumab

All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab

Randomized to Triamcinolone Acetonide (Triam)

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. AE/SAE were only assigned to this group before being switched to canakinumab

Randomized to Triam: Before Switched to Canakinumab

All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab

Randomized to Triam: After Switched to Canakinumab

All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to 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
All Randomized to Canakinumab113
Randomized to Canakinumab :Before Re-treated With Canakinumab69
Randomized to Canakinumab :After Re-treated With Canakinumab69
Randomized to Triamcinolone Acetonide (Triam)115
Randomized to Triam: Before Switched to Canakinumab39
Randomized to Triam: After Switched to Canakinumab39

Reported measurements

Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Randomized to Canakinumab76Not reportedNot reportedNot reportedNot reported
Randomized to Canakinumab :Before Re-treated With Canakinumab41Not reportedNot reportedNot reportedNot reported
Randomized to Canakinumab :After Re-treated With Canakinumab38Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone Acetonide (Triam)60Not reportedNot reportedNot reportedNot reported
Randomized to Triam: Before Switched to Canakinumab20Not reportedNot reportedNot reportedNot reported
Randomized to Triam: After Switched to Canakinumab19Not reportedNot reportedNot reportedNot reported
Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Randomized to Canakinumab1Not reportedNot reportedNot reportedNot reported
Randomized to Canakinumab :Before Re-treated With Canakinumab0Not reportedNot reportedNot reportedNot reported
Randomized to Canakinumab :After Re-treated With Canakinumab1Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone Acetonide (Triam)2Not reportedNot reportedNot reportedNot reported
Randomized to Triam: Before Switched to Canakinumab0Not reportedNot reportedNot reportedNot reported
Randomized to Triam: After Switched to Canakinumab0Not reportedNot reportedNot reportedNot reported
Serious Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Randomized to Canakinumab19Not reportedNot reportedNot reportedNot reported
Randomized to Canakinumab :Before Re-treated With Canakinumab6Not reportedNot reportedNot reportedNot reported
Randomized to Canakinumab :After Re-treated With Canakinumab8Not reportedNot reportedNot reportedNot reported
Randomized to Triamcinolone Acetonide (Triam)11Not reportedNot reportedNot reportedNot reported
Randomized to Triam: Before Switched to Canakinumab2Not reportedNot reportedNot reportedNot reported
Randomized to Triam: After Switched to Canakinumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        60
      5. group Id
        OG004
        value
        20
      6. group Id
        OG005
        value
        19
    title
    Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Death
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
    title
    Serious Adverse Event
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      69
    3. group Id
      OG002
      value
      69
    4. group Id
      OG003
      value
      115
    5. group Id
      OG004
      value
      39
    6. group Id
      OG005
      value
      39
    units
    Participants
description
This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
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
    All Randomized to Canakinumab
  2. description
    All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
    id
    OG001
    title
    Randomized to Canakinumab :Before Re-treated With Canakinumab
  3. description
    All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
    id
    OG002
    title
    Randomized to Canakinumab :After Re-treated With Canakinumab
  4. 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. AE/SAE were only assigned to this group before being switched to canakinumab
    id
    OG003
    title
    Randomized to Triamcinolone Acetonide (Triam)
  5. description
    All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
    id
    OG004
    title
    Randomized to Triam: Before Switched to Canakinumab
  6. description
    All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
    id
    OG005
    title
    Randomized to Triam: After Switched to Canakinumab
param Type
NUMBER
population Description
Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.
reporting Status
POSTED
time Frame
72 weeks overall
title
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice