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NCT00465985 · OUTCOME

Number of Participants Who Experienced a Disease Flare in Part II

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

Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) \> 30 mg/L and either a PGA \> minimal, or PGA equal to minimal and \> minimal SD.

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

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8850Not reportedNot reportedNot reportedNot reported
Placebo13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      16
    units
    Participants
description
Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) \> 30 mg/L and either a PGA \> minimal, or PGA equal to minimal and \> minimal SD.
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
Number of Participants Who Experienced a Disease Flare in Part II
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice