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NCT02552212 · OUTCOME

Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

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
LEAST_SQUARES_MEAN
Unit
scores on a scale
Interval / dispersion
Standard Error
Time frame
From Baseline to Week 12

What was measured

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. 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

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

Reported measurements

Source class 1
Values in scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo (FAS)-0.380.21Not reportedNot reportedNot reported
CZP 200 mg Q2W (FAS)-2.070.20Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -2.110
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.282
    group Description
    From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.001
    param Type
    Difference
    param Value
    -1.696
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -2.110
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.282
    group Description
    From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.001
    param Type
    Difference
    param Value
    -1.696
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.21
        value
        -0.38
      2. group Id
        OG001
        spread
        0.20
        value
        -2.07
denoms
  1. counts
    1. group Id
      OG000
      value
      158
    2. group Id
      OG001
      value
      159
    units
    Participants
description
The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
dispersion Type
Standard Error
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
LEAST_SQUARES_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 12
title
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice