NCT02552212 · OUTCOME

Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Throughout the study conduct (up to Week 52)

What was measured

The number of subjects with AU or new AU flares during the study treatment period.

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)	159

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo (FAS)	8	Not reported	Not reported	Not reported	Not reported
CZP 200 mg Q2W (FAS)	4	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.142
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.653
group Description
Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
=0.247
param Type
Odds Ratio (OR)
param Value
0.484
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.142
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.653
group Description
Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
=0.247
param Type
Odds Ratio (OR)
param Value
0.484
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
8
group Id
OG001
value
4

denoms

counts
group Id
OG000
value
158
group Id
OG001
value
159
units
Participants

description

The number of subjects with AU or new AU flares during the study treatment period.

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

COUNT_OF_PARTICIPANTS

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

Throughout the study conduct (up to Week 52)

title

Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice