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NCT00465985 · OUTCOME

Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.

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
MEAN
Unit
mg/L
Interval / dispersion
Standard Deviation
Time frame
Week 8 and Week 32

Analysis population: Intention to treat (ITT)population and LOCF.

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

C reactive protein (CRP (mg/L))
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
ACZ8851.103.086Not reportedNot reportedNot reported
Placebo19.9324.175Not reportedNot reportedNot reported
Serum amyloid A (SAA (mg/L))
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
ACZ8852.278.604Not reportedNot reportedNot reported
Placebo71.09136.637Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.086
        value
        1.10
      2. group Id
        OG001
        spread
        24.175
        value
        19.93
    title
    C reactive protein (CRP (mg/L))
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.604
        value
        2.27
      2. group Id
        OG001
        spread
        136.637
        value
        71.09
    title
    Serum amyloid A (SAA (mg/L))
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      16
    units
    Participants
dispersion Type
Standard Deviation
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
MEAN
population Description
Intention to treat (ITT)population and LOCF.
reporting Status
POSTED
time Frame
Week 8 and Week 32
title
Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.
type
SECONDARY
unit Of Measure
mg/L

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

Preserved source evidence · Not medical advice