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NCT03945019 · OUTCOME

Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) 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

Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of \>1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. 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 SC

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
Placebo SC112

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CT-P13 SC 120 mg80Not reportedNot reportedNot reportedNot reported
Placebo SC12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      112
    units
    Participants
description
Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of \>1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. 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 SC
param Type
COUNT_OF_PARTICIPANTS
population Description
All-randomized population
reporting Status
POSTED
time Frame
Week 54
title
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice