NCT02552212 · OUTCOME

Change From Baseline in ASQoL at Week 36

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: MEAN
Unit: scores on a scale
Interval / dispersion: Standard Deviation
Time frame: From Baseline to Week 36

What was measured

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Analysis population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

Groups in this outcome

Placebo (FAS)

Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).

CZP 200 mg Q2W (FAS)

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 FAS.

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
Placebo (FAS)	158
CZP 200 mg Q2W (FAS)	156

Reported measurements

Source class 1

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo (FAS)	-0.11	0.23	Not reported	Not reported	Not reported
CZP 200 mg Q2W (FAS)	-0.33	0.29	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.23
value
-0.11
group Id
OG001
spread
0.29
value
-0.33

denoms

counts
group Id
OG000
value
158
group Id
OG001
value
156
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).
id
OG000
title
Placebo (FAS)
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 FAS.
id
OG001
title
CZP 200 mg Q2W (FAS)

param Type

MEAN

population Description

The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

reporting Status

POSTED

time Frame

From Baseline to Week 36

title

Change From Baseline in ASQoL at Week 36

type

SECONDARY

unit Of Measure

scores on a scale

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

Preserved source evidence · Not medical advice