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NCT02552212 · OUTCOME

Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS · Source last updated 2022-08-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
µg/mL
Interval / dispersion
95% Confidence Interval
Time frame
Follow-up Visit (up to Week 60)

What was measured

Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL. Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.

Analysis population: The SS consisted of all subjects who received at least 1 dose of study treatment. Only participants included, who had a SFU Visit at 8 weeks after Week 52/WD visit for those not participating in the SFE period.

Groups in this outcome

CZP 200 mg Q2W (SS)

Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.

Placebo->OL CZP (SS)

Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.

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

Analysis denominator · Participants

GroupSource count
CZP 200 mg Q2W (SS)17
Placebo->OL CZP (SS)10

Reported measurements

Source class 1
Values in µg/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CZP 200 mg Q2W (SS)0.2Not reported0.10.7Not reported
Placebo->OL CZP (SS)NANot reportedNANAValues were below the level of quantification.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        0.7
        value
        0.2
      2. comment
        Values were below the level of quantification.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL. Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.
dispersion Type
95% Confidence Interval
groups
  1. description
    Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
    id
    OG000
    title
    CZP 200 mg Q2W (SS)
  2. description
    Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
    id
    OG001
    title
    Placebo->OL CZP (SS)
param Type
GEOMETRIC_MEAN
population Description
The SS consisted of all subjects who received at least 1 dose of study treatment. Only participants included, who had a SFU Visit at 8 weeks after Week 52/WD visit for those not participating in the SFE period.
reporting Status
POSTED
time Frame
Follow-up Visit (up to Week 60)
title
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
type
PRIMARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice