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NCT00422383 · OUTCOME

Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
BL, Weeks 8, 24, and 48

What was measured

Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF ≥ 20 international units (IU) per mL. RF seronegative status was defined as RF \< 20 IU/mL.

Analysis population: RF seropositive participants from the ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.

Groups in this outcome

Rituximab Low Dose + Methotrexate

Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.

Rituximab Escalated Dose + Methotrexate

Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.

Rituximab High Dose + Methotrexate

Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rituximab Low Dose + Methotrexate93
Rituximab Escalated Dose + Methotrexate84
Rituximab High Dose + Methotrexate60

Reported measurements

Wk 8 (n=93,84,60)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate9.7Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate9.5Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate5.0Not reportedNot reportedNot reportedNot reported
Wk 24 (n=83,79,56)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate22.9Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate21.5Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate16.1Not reportedNot reportedNot reportedNot reported
Wk 48 (n=85,78,60)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate30.6Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate30.8Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate23.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9.7
      2. group Id
        OG001
        value
        9.5
      3. group Id
        OG002
        value
        5.0
    title
    Wk 8 (n=93,84,60)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22.9
      2. group Id
        OG001
        value
        21.5
      3. group Id
        OG002
        value
        16.1
    title
    Wk 24 (n=83,79,56)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        30.6
      2. group Id
        OG001
        value
        30.8
      3. group Id
        OG002
        value
        23.3
    title
    Wk 48 (n=85,78,60)
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    2. group Id
      OG001
      value
      84
    3. group Id
      OG002
      value
      60
    units
    Participants
description
Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF ≥ 20 international units (IU) per mL. RF seronegative status was defined as RF \< 20 IU/mL.
groups
  1. description
    Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    OG000
    title
    Rituximab Low Dose + Methotrexate
  2. description
    Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    OG001
    title
    Rituximab Escalated Dose + Methotrexate
  3. description
    Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    OG002
    title
    Rituximab High Dose + Methotrexate
param Type
NUMBER
population Description
RF seropositive participants from the ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.
reporting Status
POSTED
time Frame
BL, Weeks 8, 24, and 48
title
Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice