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NCT01356602 · OUTCOME

Physician's Assessment of Range of Motion of the Most Affected Joint

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

The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).

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

Normal
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)50.0Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)44.8Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide35.5Not reportedNot reportedNot reportedNot reported
Mildly restricted
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)37.7Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)40.8Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide37.2Not reportedNot reportedNot reportedNot reported
Moderately restricted
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)11.5Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)12.0Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide14.0Not reportedNot reportedNot reportedNot reported
Severely restricted
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)0.8Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)2.4Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide12.4Not reportedNot reportedNot reportedNot reported
Immobilized
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)0.0Not reportedNot reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)0.0Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide0.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50.0
      2. group Id
        OG001
        value
        44.8
      3. group Id
        OG002
        value
        35.5
    title
    Normal
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        37.7
      2. group Id
        OG001
        value
        40.8
      3. group Id
        OG002
        value
        37.2
    title
    Mildly restricted
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11.5
      2. group Id
        OG001
        value
        12.0
      3. group Id
        OG002
        value
        14.0
    title
    Moderately restricted
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
      2. group Id
        OG001
        value
        2.4
      3. group Id
        OG002
        value
        12.4
    title
    Severely restricted
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.8
    title
    Immobilized
denoms
  1. counts
    1. group Id
      OG000
      value
      131
    2. group Id
      OG001
      value
      129
    3. group Id
      OG002
      value
      129
    units
    Participants
description
The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).
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 Assessment of Range of Motion of the Most Affected Joint
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice