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NCT02277444 · FLOW

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A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy · Source last updated 2025-11-14

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

groups
  1. description
    Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
    id
    FG000
    title
    Golimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Enrolled and not Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        130
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        127
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Treatment Period (Week 0-52)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        43
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      NOT COMPLETED
    title
    LTE Period (Week 52 to Week 252)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      comment
      Participants who completed the study through Week 252, for whom the drug was found to be beneficial but was not commercially available for polyarticular juvenile idiopathic arthritis, were enrolled in the ETP at Week 252.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    ETP Period (Week 252 to Week 420)
Complete source fields
groups
  1. description
    Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
    id
    FG000
    title
    Golimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Enrolled and not Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        130
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        127
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        112
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Treatment Period (Week 0-52)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        43
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        112
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      NOT COMPLETED
    title
    LTE Period (Week 52 to Week 252)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      comment
      Participants who completed the study through Week 252, for whom the drug was found to be beneficial but was not commercially available for polyarticular juvenile idiopathic arthritis, were enrolled in the ETP at Week 252.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    ETP Period (Week 252 to Week 420)

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Preserved source evidence · Not medical advice