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NCT02181673 · FLOW

Participant flow

A Study of Golimumab in Participants With Active Psoriatic Arthritis · Source last updated 2017-12-21

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

groups
  1. description
    Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
    id
    FG000
    title
    Placebo (Week 0-24)
  2. description
    Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
    id
    FG001
    title
    Placebo Then Golimumab 2 mg/kg (Week 24-60)
  3. description
    Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
    id
    FG002
    title
    Golimumab 2 mg/kg (Week 0-60)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Randomized not Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        239
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        241
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        239
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        240
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        222
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        230
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Up to Week 24
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lack of Efficacy
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        222
      3. group Id
        FG002
        num Subjects
        230
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        220
      3. group Id
        FG002
        num Subjects
        230
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        214
      3. group Id
        FG002
        num Subjects
        213
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Week 24-Week 60
Complete source fields
groups
  1. description
    Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
    id
    FG000
    title
    Placebo (Week 0-24)
  2. description
    Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
    id
    FG001
    title
    Placebo Then Golimumab 2 mg/kg (Week 24-60)
  3. description
    Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
    id
    FG002
    title
    Golimumab 2 mg/kg (Week 0-60)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Randomized not Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        239
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        241
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        239
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        240
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        222
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        230
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Up to Week 24
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lack of Efficacy
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        222
      3. group Id
        FG002
        num Subjects
        230
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        220
      3. group Id
        FG002
        num Subjects
        230
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        214
      3. group Id
        FG002
        num Subjects
        213
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Week 24-Week 60

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Preserved source evidence · Not medical advice