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NCT02186873 · FLOW

Participant flow

A Study of Golimumab in Participants With Active Ankylosing Spondylitis · Source last updated 2025-10-30

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

groups
  1. description
    Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
    id
    FG000
    title
    Group 1: Placebo Then Golimumab
  2. description
    Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
    id
    FG001
    title
    Group 2: Golimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        105
      type
      STARTED
    2. achievements
      1. comment
        Participants taking placebo crossed over to golimumab
        group Id
        FG000
        num Subjects
        99
      2. comment
        Participants continued to receive golimumab
        group Id
        FG001
        num Subjects
        105
      type
      End of Control Period
    3. achievements
      1. group Id
        FG000
        num Subjects
        94
      2. group Id
        FG001
        num Subjects
        97
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram \[mg/kg\] and 103 to placebo group) and treated.
Complete source fields
groups
  1. description
    Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
    id
    FG000
    title
    Group 1: Placebo Then Golimumab
  2. description
    Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
    id
    FG001
    title
    Group 2: Golimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        105
      type
      STARTED
    2. achievements
      1. comment
        Participants taking placebo crossed over to golimumab
        group Id
        FG000
        num Subjects
        99
      2. comment
        Participants continued to receive golimumab
        group Id
        FG001
        num Subjects
        105
      type
      End of Control Period
    3. achievements
      1. group Id
        FG000
        num Subjects
        94
      2. group Id
        FG001
        num Subjects
        97
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram \[mg/kg\] and 103 to placebo group) and treated.

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Preserved source evidence · Not medical advice