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NCT01550003 · OUTCOME

Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 48

What was measured

Number of participants with anti-CZP antibodies were reported.

Analysis population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

Reduced CZP Dose

Participants received reduced 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.

Original CZP Dose

Participants received original 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
Reduced CZP Dose72
Original CZP Dose60

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Reduced CZP Dose58Not reportedNot reportedNot reportedNot reported
Original CZP Dose47Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        47
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      60
    units
    Participants
description
Number of participants with anti-CZP antibodies were reported.
groups
  1. description
    Participants received reduced 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
    Reduced CZP Dose
  2. description
    Participants received original 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
    Original CZP Dose
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Week 48
title
Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice