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NCT01550003 · OUTCOME

Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16

Pediatric Arthritis Study of Certolizumab Pegol · Source last updated 2024-10-23

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
95% Confidence Interval
Time frame
Week 16

What was measured

PedACR50- at least 50% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment (PGA) of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * Childhood Health Assessment Questionnaire (CHAQ) (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP

Analysis population: FAS:all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, PGA of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.

Groups in this outcome

Any CZP Dose - Weight Group: 10 - <20 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Any CZP Dose - Weight Group: 20 - <40 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Any CZP Dose - Weight Group: >=40 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

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

Analysis denominator · Participants

GroupSource count
Any CZP Dose - Weight Group: 10 - <20 kg18
Any CZP Dose - Weight Group: 20 - <40 kg63
Any CZP Dose - Weight Group: >=40 kg112

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Any CZP Dose - Weight Group: 10 - <20 kg66.7Not reported41.086.7Not reported
Any CZP Dose - Weight Group: 20 - <40 kg71.4Not reported58.782.1Not reported
Any CZP Dose - Weight Group: >=40 kg74.1Not reported65.081.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.0
        upper Limit
        86.7
        value
        66.7
      2. group Id
        OG001
        lower Limit
        58.7
        upper Limit
        82.1
        value
        71.4
      3. group Id
        OG002
        lower Limit
        65.0
        upper Limit
        81.9
        value
        74.1
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      63
    3. group Id
      OG002
      value
      112
    units
    Participants
description
PedACR50- at least 50% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment (PGA) of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * Childhood Health Assessment Questionnaire (CHAQ) (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    OG000
    title
    Any CZP Dose - Weight Group: 10 - <20 kg
  2. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    OG001
    title
    Any CZP Dose - Weight Group: 20 - <40 kg
  3. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    OG002
    title
    Any CZP Dose - Weight Group: >=40 kg
param Type
NUMBER
population Description
FAS:all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, PGA of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
reporting Status
POSTED
time Frame
Week 16
title
Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice