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NCT00487539 · OUTCOME

Number of Participants With Clinical Response 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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, Week 6

What was measured

Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.

Analysis population: Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.

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
Placebo251
Golimumab 200 mg -> 100 mg253
Golimumab 400 mg -> 200 mg257

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo76Not reportedNot reportedNot reportedNot reported
Golimumab 200 mg -> 100 mg129Not reportedNot reportedNot reportedNot reported
Golimumab 400 mg -> 200 mg141Not reportedNot 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 Method
    Chi-squared
    tested Non Inferiority
    false
  2. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Chi-squared
    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 Method
    Chi-squared
    tested Non Inferiority
    false
  2. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        129
      3. group Id
        OG002
        value
        141
denoms
  1. counts
    1. group Id
      OG000
      value
      251
    2. group Id
      OG001
      value
      253
    3. group Id
      OG002
      value
      257
    units
    Participants
description
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
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
NUMBER
population Description
Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.
reporting Status
POSTED
time Frame
Baseline, Week 6
title
Number of Participants With Clinical Response at Week 6
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice