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NCT04205643 · FLOW

Participant flow

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) · Source last updated 2023-09-28

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

groups
  1. description
    Induction phase: Patients who enrolled received induction doses of CT-P13 5mg/kg via intravenous (IV) infusion at Weeks 0, 2, and 6.
    id
    FG000
    title
    CT-P13 IV 5mg/kg
  2. description
    Maintenance phase: Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.
    id
    FG001
    title
    CT-P13 SC 120 mg
  3. description
    Maintenance phase: Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.
    id
    FG002
    title
    Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        548
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        438
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Induction Phase
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        294
      3. group Id
        FG002
        num Subjects
        144
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        240
      3. group Id
        FG002
        num Subjects
        113
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Maintenance Phase
Complete source fields
groups
  1. description
    Induction phase: Patients who enrolled received induction doses of CT-P13 5mg/kg via intravenous (IV) infusion at Weeks 0, 2, and 6.
    id
    FG000
    title
    CT-P13 IV 5mg/kg
  2. description
    Maintenance phase: Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.
    id
    FG001
    title
    CT-P13 SC 120 mg
  3. description
    Maintenance phase: Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.
    id
    FG002
    title
    Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        548
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        438
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Induction Phase
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        294
      3. group Id
        FG002
        num Subjects
        144
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        240
      3. group Id
        FG002
        num Subjects
        113
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Maintenance Phase

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

Preserved source evidence · Not medical advice