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NCT00973479 · FLOW

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An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy · Source last updated 2013-12-25

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

groups
  1. description
    Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
    id
    FG000
    title
    Group I: Placebo + Methotrexate (MTX)
  2. description
    Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
    id
    FG001
    title
    Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        32
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        197
      2. group Id
        FG001
        num Subjects
        395
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        160
      2. group Id
        FG001
        num Subjects
        326
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        69
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
592 participants were randomly allocated to 2 treatment arms. At Week 16 some participants in Placebo arm switched to Golimumab earlier than the rest at Week 24. Thus, the Adverse Events are presented based upon the time when participants began to receive Golimumab in the following manner: Golimumab from Day 0, from Week 16 and from Week 24.
recruitment Details
This study evaluated the efficacy and safety of intravenous administration of Golimumab 2mg/kg + methotrexate (MTX) in patients with Active Rheumatoid Arthritis despite treatment with MTX therapy. It was conducted between 14 September 2009 and 08 February 2013 and recruited participants at 92 sites in 13 countries worldwide.
Complete source fields
groups
  1. description
    Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
    id
    FG000
    title
    Group I: Placebo + Methotrexate (MTX)
  2. description
    Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
    id
    FG001
    title
    Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        32
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        197
      2. group Id
        FG001
        num Subjects
        395
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        160
      2. group Id
        FG001
        num Subjects
        326
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        69
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
592 participants were randomly allocated to 2 treatment arms. At Week 16 some participants in Placebo arm switched to Golimumab earlier than the rest at Week 24. Thus, the Adverse Events are presented based upon the time when participants began to receive Golimumab in the following manner: Golimumab from Day 0, from Week 16 and from Week 24.
recruitment Details
This study evaluated the efficacy and safety of intravenous administration of Golimumab 2mg/kg + methotrexate (MTX) in patients with Active Rheumatoid Arthritis despite treatment with MTX therapy. It was conducted between 14 September 2009 and 08 February 2013 and recruited participants at 92 sites in 13 countries worldwide.

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Preserved source evidence · Not medical advice