Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02552212 · OUTCOME

Certolizumab Pegol Plasma Concentration at Week 12

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
Week 12

What was measured

Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.

Analysis population: The SS consisted of all subjects who received at least 1 dose of study treatment.

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)143
Placebo->OL CZP (SS)93

Reported measurements

Source class 1
Values in µg/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CZP 200 mg Q2W (SS)29.1Not reported24.035.2Not reported
Placebo->OL CZP (SS)30.5Not reported26.435.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.0
        upper Limit
        35.2
        value
        29.1
      2. group Id
        OG001
        lower Limit
        26.4
        upper Limit
        35.3
        value
        30.5
denoms
  1. counts
    1. group Id
      OG000
      value
      143
    2. group Id
      OG001
      value
      93
    units
    Participants
description
Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
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.
reporting Status
POSTED
time Frame
Week 12
title
Certolizumab Pegol Plasma Concentration at Week 12
type
PRIMARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice