Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01356602 · OUTCOME

Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients · Source last updated 2014-01-29

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

What was measured

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).

Analysis population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.

Groups in this outcome

Canakinumab, Pre-filled Syringes (PFS)

Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.

Canakinumab, Lyophilizate (LYO)

The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.

Triamcinolone Acetonide

The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

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, Pre-filled Syringes (PFS)131
Canakinumab, Lyophilizate (LYO)129
Triamcinolone Acetonide129

Reported measurements

Very good
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)46.2Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)33.6Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide21.5Not reportedNot reportedNot reportedNot reported
Good
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)35.4Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)48.8Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide33.9Not reportedNot reportedNot reportedNot reported
Fair
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)15.4Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)16.0Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide23.1Not reportedNot reportedNot reportedNot reported
Poor
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)1.5Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)1.6Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide14.0Not reportedNot reportedNot reportedNot reported
Very poor
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)1.5Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)0.0Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide7.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46.2
      2. group Id
        OG001
        value
        33.6
      3. group Id
        OG002
        value
        21.5
    title
    Very good
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        35.4
      2. group Id
        OG001
        value
        48.8
      3. group Id
        OG002
        value
        33.9
    title
    Good
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15.4
      2. group Id
        OG001
        value
        16.0
      3. group Id
        OG002
        value
        23.1
    title
    Fair
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        1.6
      3. group Id
        OG002
        value
        14.0
    title
    Poor
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        7.4
    title
    Very poor
denoms
  1. counts
    1. group Id
      OG000
      value
      131
    2. group Id
      OG001
      value
      129
    3. group Id
      OG002
      value
      129
    units
    Participants
description
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).
groups
  1. description
    Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
    id
    OG000
    title
    Canakinumab, Pre-filled Syringes (PFS)
  2. description
    The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
    id
    OG001
    title
    Canakinumab, Lyophilizate (LYO)
  3. description
    The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
    id
    OG002
    title
    Triamcinolone Acetonide
param Type
NUMBER
population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
reporting Status
POSTED
time Frame
72 hours
title
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice