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NCT00465985 · OUTCOME

Number of Participants With Treatment Response in Part I (After 8 Weeks)

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
8 weeks after study start

What was measured

Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by \>30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA \> 30 mg/L and either PGA \> minimal or PGA = minimal and SD \> minimal. Non-responders = no PR by Day 8 or no CR by Day 15.

Groups in this outcome

ACZ885

ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, 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
ACZ88535

Reported measurements

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8853125.200Not reportedNot reportedNot reported
Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8852Not reportedNot reportedNot reportedNot reported
Disease flare
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8851Not reportedNot reportedNot reportedNot reported
Non-responder (protocol violation)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ACZ8851Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.200
        value
        31
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Disease flare
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non-responder (protocol violation)
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by \>30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA \> 30 mg/L and either PGA \> minimal or PGA = minimal and SD \> minimal. Non-responders = no PR by Day 8 or no CR by Day 15.
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
param Type
NUMBER
reporting Status
POSTED
time Frame
8 weeks after study start
title
Number of Participants With Treatment Response in Part I (After 8 Weeks)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice