Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03596645 · FLOW

Participant flow

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2026-08-31

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

groups
  1. description
    In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
    id
    FG000
    title
    Group 1: Golimumab
  2. description
    In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.
    id
    FG001
    title
    Group 2: Infliximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Initiated Prohibited Medication
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Parent/Guardian
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No mucosal healing achieved
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    10. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        12
      type
      Ongoing
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Randomized but not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        14
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        15
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Results are currently reported until the primary completion date (21-Nov-2023). Final results will be posted upon study completion.
Complete source fields
groups
  1. description
    In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
    id
    FG000
    title
    Group 1: Golimumab
  2. description
    In short term phase (Week 0-6), participants weighing \>=30 kg, received infliximab 5 mg/kg intravenous (IV) infusion at Week 0 and Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued to receive infliximab 5 mg/kg IV infusion every 8 weeks (q8w) through Week 46. Participants who did not show a clinical response at Week 6 received an increased dose of infliximab that is 10 mg/kg (capped at 1 gram) starting at Week 6 and every q8q thereafter, or 5 mg/kg at Week 6 and Week 8 followed by 10 mg/kg (capped at 1 gram) at Week 14 and every q8w thereafter. Participants who showed a partial Mayo responders at Week 14 continued infliximab 10 mg/kg every 8 weeks through Week 46. Participants who did not show partial Mayo response at Week 14 either received a further dose escalation to 10 mg/kg q4w (capped at 1 gram) or were withdrawn from the study. At Week 22, participants who received the escalated dose of infliximab 10 mg/kg q4w were required to show a partial Mayo response and who met this criterion continued to receive open-label infliximab 10 mg/kg (capped at 1 gram) q4w through Week 50. After Week 54 evaluations, participants receiving infliximab were withdrawn from study participation and transitioned to local standard of care.
    id
    FG001
    title
    Group 2: Infliximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Initiated Prohibited Medication
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Parent/Guardian
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No mucosal healing achieved
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    10. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        12
      type
      Ongoing
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Randomized but not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        14
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        15
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Results are currently reported until the primary completion date (21-Nov-2023). Final results will be posted upon study completion.

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

Preserved source evidence · Not medical advice