NCT02552212 · OUTCOME

Certolizumab Pegol Plasma Concentration at Week 4

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 4

What was measured

Certolizumab pegol plasma concentration was measured at Week 4, 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

Group	Source count
CZP 200 mg Q2W (SS)	155
Placebo->OL CZP (SS)	93

Reported measurements

Source class 1

Values in µg/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
CZP 200 mg Q2W (SS)	54.6	Not reported	51.4	58.0	Not reported
Placebo->OL CZP (SS)	48.8	Not reported	42.2	56.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
51.4
upper Limit
58.0
value
54.6
group Id
OG001
lower Limit
42.2
upper Limit
56.4
value
48.8

denoms

counts
group Id
OG000
value
155
group Id
OG001
value
93
units
Participants

description

Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.

dispersion Type

95% Confidence Interval

groups

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)
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 4

title

Certolizumab Pegol Plasma Concentration at Week 4

type

PRIMARY

unit Of Measure

µg/mL

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

Preserved source evidence · Not medical advice