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NCT00282308 · FLOW

Participant flow

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2017-08-10

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

groups
  1. description
    Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    FG000
    title
    Rituximab + Methotrexate (Group A)
  2. description
    Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    FG001
    title
    Methotrexate (Group B)
  3. description
    Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
    id
    FG002
    title
    All Patients (Combined Groups A and B)
periods
  1. drop Withdraws
    1. 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
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject/Guardian Decision to Withdraw
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Not Treated with Study Drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        34
      3. comment
        Participant Flow is reported separately for the treatment groups for this Period.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician's Decision to Withdraw
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Subject/Guardian Decision to Withdraw
    milestones
    1. achievements
      1. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Not all patients who completed the Treatment Period entered this Optional Re-treatment Period.
        group Id
        FG002
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        72
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Optional Extension Re-treatment Period
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Lost to Follow-up
    3. 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 to Withdraw
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Subject/Guardian Decision to Withdraw
    milestones
    1. achievements
      1. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Some patients entered this Safety Follow-up Period directly from the Treatment Period.
        group Id
        FG002
        num Subjects
        100
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        81
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Safety Follow-up Period
Complete source fields
groups
  1. description
    Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    FG000
    title
    Rituximab + Methotrexate (Group A)
  2. description
    Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    FG001
    title
    Methotrexate (Group B)
  3. description
    Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
    id
    FG002
    title
    All Patients (Combined Groups A and B)
periods
  1. drop Withdraws
    1. 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
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject/Guardian Decision to Withdraw
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Not Treated with Study Drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        34
      3. comment
        Participant Flow is reported separately for the treatment groups for this Period.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician's Decision to Withdraw
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Subject/Guardian Decision to Withdraw
    milestones
    1. achievements
      1. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Not all patients who completed the Treatment Period entered this Optional Re-treatment Period.
        group Id
        FG002
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        72
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Optional Extension Re-treatment Period
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Lost to Follow-up
    3. 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 to Withdraw
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Subject/Guardian Decision to Withdraw
    milestones
    1. achievements
      1. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG000
        num Subjects
        0
      2. comment
        Participant Flow is reported for the combined treatment groups for this Period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Some patients entered this Safety Follow-up Period directly from the Treatment Period.
        group Id
        FG002
        num Subjects
        100
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        81
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Safety Follow-up Period

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice