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NCT00299130 · FLOW

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A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis · Source last updated 2017-04-17

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 infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    FG000
    title
    Placebo + MTX
  2. description
    Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    FG001
    title
    Rituximab 2 x 0.5 g + MTX
  3. description
    Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    FG002
    title
    Rituximab 2 x 1.0 g + MTX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        13
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      type
      Insufficient Therapeutic Response
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        19
      type
      Refused Treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      type
      Failure to Return
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Reason not Specified
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        172
      2. group Id
        FG001
        num Subjects
        168
      3. group Id
        FG002
        num Subjects
        171
      type
      STARTED
    2. achievements
      1. comment
        155 participants in placebo arm switched to active therapy (rituximab 2 x 0.5g) between Weeks 16-48.
        group Id
        FG000
        num Subjects
        172
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        170
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        162
      3. group Id
        FG002
        num Subjects
        166
      type
      Completed 24 Weeks
    4. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        157
      3. group Id
        FG002
        num Subjects
        158
      type
      Completed 48 Weeks
    5. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        138
      3. group Id
        FG002
        num Subjects
        132
      type
      Completed 144 Weeks
    6. achievements
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        125
      3. group Id
        FG002
        num Subjects
        121
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        50
      type
      NOT COMPLETED
    title
    Treatment Period (up to 5 Years)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        4
      type
      Administrative/Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Did not Co-operate
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        15
      type
      Failure to Return
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      No SFU Week 48 Date Recorded
    6. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        21
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        165
      3. group Id
        FG002
        num Subjects
        168
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        122
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        123
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        45
      type
      NOT COMPLETED
    title
    Safety Follow-up (SFU) (48 Weeks)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Failure to Return
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Did not Cooperate/Withdrew Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        82
      3. group Id
        FG002
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        74
      3. group Id
        FG002
        num Subjects
        38
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Extended SFU (ESFU) (up to 5.1 Years)
pre Assignment Details
Of the 509 participants, one participant was randomized first to rituximab 2 x 1.0 g + MTX and then to rituximab 2 x 0.5 g + MTX. No assessments were recorded or medication given after first randomization and all data used in analyses was following the second randomization; hence, participant is included only in rituximab 2 x 0.5 g + MTX arm.
recruitment Details
A total of 511 participants were recruited and randomized between 27 Oct 2005 and 15 Nov 2006. Of these, 2 participants were randomized but received no infusions (one violated inclusion criteria and the other was randomized to rituximab 2 x 1.0 gram \[g\] + methotrexate \[MTX\] but failed to return). A total of 509 participants were treated.
Complete source fields
groups
  1. description
    Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    FG000
    title
    Placebo + MTX
  2. description
    Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    FG001
    title
    Rituximab 2 x 0.5 g + MTX
  3. description
    Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    FG002
    title
    Rituximab 2 x 1.0 g + MTX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        13
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      type
      Insufficient Therapeutic Response
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        19
      type
      Refused Treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      type
      Failure to Return
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Reason not Specified
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        172
      2. group Id
        FG001
        num Subjects
        168
      3. group Id
        FG002
        num Subjects
        171
      type
      STARTED
    2. achievements
      1. comment
        155 participants in placebo arm switched to active therapy (rituximab 2 x 0.5g) between Weeks 16-48.
        group Id
        FG000
        num Subjects
        172
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        170
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        162
      3. group Id
        FG002
        num Subjects
        166
      type
      Completed 24 Weeks
    4. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        157
      3. group Id
        FG002
        num Subjects
        158
      type
      Completed 48 Weeks
    5. achievements
      1. group Id
        FG000
        num Subjects
        133
      2. group Id
        FG001
        num Subjects
        138
      3. group Id
        FG002
        num Subjects
        132
      type
      Completed 144 Weeks
    6. achievements
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        125
      3. group Id
        FG002
        num Subjects
        121
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        50
      type
      NOT COMPLETED
    title
    Treatment Period (up to 5 Years)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        4
      type
      Administrative/Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Did not Co-operate
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        15
      type
      Failure to Return
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      No SFU Week 48 Date Recorded
    6. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        21
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        165
      3. group Id
        FG002
        num Subjects
        168
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        122
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        123
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        45
      type
      NOT COMPLETED
    title
    Safety Follow-up (SFU) (48 Weeks)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Failure to Return
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Did not Cooperate/Withdrew Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        82
      3. group Id
        FG002
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        74
      3. group Id
        FG002
        num Subjects
        38
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Extended SFU (ESFU) (up to 5.1 Years)
pre Assignment Details
Of the 509 participants, one participant was randomized first to rituximab 2 x 1.0 g + MTX and then to rituximab 2 x 0.5 g + MTX. No assessments were recorded or medication given after first randomization and all data used in analyses was following the second randomization; hence, participant is included only in rituximab 2 x 0.5 g + MTX arm.
recruitment Details
A total of 511 participants were recruited and randomized between 27 Oct 2005 and 15 Nov 2006. Of these, 2 participants were randomized but received no infusions (one violated inclusion criteria and the other was randomized to rituximab 2 x 1.0 gram \[g\] + methotrexate \[MTX\] but failed to return). A total of 509 participants were treated.

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Preserved source evidence · Not medical advice