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NCT00487539 · OUTCOME

Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2014-02-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Units on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline to Week 6

What was measured

The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.

Analysis population: Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Groups in this outcome

Placebo

Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.

Golimumab 200 mg -> 100 mg

Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.

Golimumab 400 mg -> 200 mg

Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo250
Golimumab 200 mg -> 100 mg252
Golimumab 400 mg -> 200 mg255

Reported measurements

Baseline
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo129.632.61Not reportedNot reportedNot reported
Golimumab 200 mg -> 100 mg131.733.93Not reportedNot reportedNot reported
Golimumab 400 mg -> 200 mg127.233.90Not reportedNot reportedNot reported
Change at Week 6
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo14.831.25Not reportedNot reportedNot reported
Golimumab 200 mg -> 100 mg27.033.72Not reportedNot reportedNot reported
Golimumab 400 mg -> 200 mg26.934.28Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Comment
    on the van der Waerden normal scores
    statistical Method
    ANOVA
    tested Non Inferiority
    false
  2. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Comment
    on the van der Waerden normal scores
    statistical Method
    ANOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Comment
    on the van der Waerden normal scores
    statistical Method
    ANOVA
    tested Non Inferiority
    false
  2. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Comment
    on the van der Waerden normal scores
    statistical Method
    ANOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.61
        value
        129.6
      2. group Id
        OG001
        spread
        33.93
        value
        131.7
      3. group Id
        OG002
        spread
        33.90
        value
        127.2
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.25
        value
        14.8
      2. group Id
        OG001
        spread
        33.72
        value
        27.0
      3. group Id
        OG002
        spread
        34.28
        value
        26.9
    title
    Change at Week 6
denoms
  1. counts
    1. group Id
      OG000
      value
      250
    2. group Id
      OG001
      value
      252
    3. group Id
      OG002
      value
      255
    units
    Participants
description
The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.
dispersion Type
Standard Deviation
groups
  1. description
    Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
    id
    OG000
    title
    Placebo
  2. description
    Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
    id
    OG001
    title
    Golimumab 200 mg -> 100 mg
  3. description
    Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
    id
    OG002
    title
    Golimumab 400 mg -> 200 mg
param Type
MEAN
population Description
Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
reporting Status
POSTED
time Frame
Baseline to Week 6
title
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
type
SECONDARY
unit Of Measure
Units on a Scale

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

Preserved source evidence · Not medical advice