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NCT03945019 · OUTCOME

Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) · Source last updated 2023-10-23

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
Week 54

What was measured

Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Analysis population: All-randomized population

Groups in this outcome

CT-P13 SC 120 mg

CT-P13 SC 120 mg

Placebo

Placebo

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

Analysis denominator · Participants

GroupSource count
CT-P13 SC 120 mg231
Placebo112

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CT-P13 SC 120 mg144Not reportedNot reportedNot reportedNot reported
Placebo36Not 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
    p Value
    <0.0001
    statistical Comment
    Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Comment
    Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        144
      2. group Id
        OG001
        value
        36
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      112
    units
    Participants
description
Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
groups
  1. description
    CT-P13 SC 120 mg
    id
    OG000
    title
    CT-P13 SC 120 mg
  2. description
    Placebo
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
All-randomized population
reporting Status
POSTED
time Frame
Week 54
title
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice