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NCT02552212 · OUTCOME

Number of Subjects Without Relevant Changes to Background Medication From Baseline to 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
From Baseline to Week 52

What was measured

The number of subjects who did not have relevant changes to background medications during the study treatment period. A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52.

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

GroupSource count
Placebo (FAS)158
CZP 200 mg Q2W (FAS)159

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo (FAS)48Not reportedNot reportedNot reportedNot reported
CZP 200 mg Q2W (FAS)115Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    3.800
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.191
    group Description
    Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    6.223
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    3.800
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.191
    group Description
    Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    6.223
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        115
denoms
  1. counts
    1. group Id
      OG000
      value
      158
    2. group Id
      OG001
      value
      159
    units
    Participants
description
The number of subjects who did not have relevant changes to background medications during the study treatment period. A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52.
groups
  1. 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)
  2. 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
From Baseline to Week 52
title
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice