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NCT00465985 · OUTCOME

Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)

Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome · Source last updated 2017-08-28

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
32 weeks after study start

What was measured

A 5-point scale was used for the Physician's global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items: * skin disease (urticarial skin rash) * arthralgia * myalgia * headache/migraine * conjunctivitis * fatigue/malaise * other symptoms related to autoinflammatory syndrome * other symptoms not related to autoinflammatory syndrome

Groups in this outcome

ACZ885

ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.

Placebo

Placebo subcutaneous injection every 8 weeks.

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

Analysis denominator · Participants

GroupSource count
ACZ88515
Placebo16

Reported measurements

Absent
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8858Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Minimal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8857Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Mild
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8850Not reportedNot reportedNot reportedNot reported
Placebo8Not reportedNot reportedNot reportedNot reported
Moderate
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8850Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Severe
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8850Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
    title
    Absent
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
    title
    Minimal
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        8
    title
    Mild
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
    title
    Moderate
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Severe
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      16
    units
    Participants
description
A 5-point scale was used for the Physician's global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items: * skin disease (urticarial skin rash) * arthralgia * myalgia * headache/migraine * conjunctivitis * fatigue/malaise * other symptoms related to autoinflammatory syndrome * other symptoms not related to autoinflammatory syndrome
groups
  1. description
    ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
    id
    OG000
    title
    ACZ885
  2. description
    Placebo subcutaneous injection every 8 weeks.
    id
    OG001
    title
    Placebo
param Type
NUMBER
reporting Status
POSTED
time Frame
32 weeks after study start
title
Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice