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NCT00422383 · OUTCOME

Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category

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
Week 48

What was measured

EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR ≤ 3.2 at Week 48 and a change from BL to Week 48 \< -1.2 = good response, DAS28-ESR ≤ 3.2 or greater than (\>) 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 \< -0.6 and ≥ -1.2 = moderate response, DAS28-ESR \> 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 \< -1.2 = moderate response, DAS28-ESR \> 5.1 at Week 48 and a change from BL to Week 48 \< -1.2 = moderate response, DAS28-ESR ≤ 3.2 or \> 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 ≥ -0.6 = no response, DAS28-ESR \> 5.1 at Week 48 and a change from BL to Week 48 \< -0.6 and ≥ -1.2 or ≥ -0.6 = no response.

Analysis population: ITT-M2 population

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 + Methotrexate134
Rituximab Escalated Dose + Methotrexate119
Rituximab High Dose + Methotrexate93

Reported measurements

None
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate26.9Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate27.7Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate10.8Not reportedNot reportedNot reportedNot reported
Moderate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate50.7Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate55.5Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate62.4Not reportedNot reportedNot reportedNot reported
Good
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate22.4Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate16.8Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate26.9Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5029
    p Value Comment
    Stratified by region, prior biologic use, RF status, and treatment.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0495
    p Value Comment
    Stratified by region, prior biologic use, RF status, and treatment.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5029
    p Value Comment
    Stratified by region, prior biologic use, RF status, and treatment.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0495
    p Value Comment
    Stratified by region, prior biologic use, RF status, and treatment.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26.9
      2. group Id
        OG001
        value
        27.7
      3. group Id
        OG002
        value
        10.8
    title
    None
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50.7
      2. group Id
        OG001
        value
        55.5
      3. group Id
        OG002
        value
        62.4
    title
    Moderate
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
      2. group Id
        OG001
        value
        16.8
      3. group Id
        OG002
        value
        26.9
    title
    Good
denoms
  1. counts
    1. group Id
      OG000
      value
      134
    2. group Id
      OG001
      value
      119
    3. group Id
      OG002
      value
      93
    units
    Participants
description
EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR ≤ 3.2 at Week 48 and a change from BL to Week 48 \< -1.2 = good response, DAS28-ESR ≤ 3.2 or greater than (\>) 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 \< -0.6 and ≥ -1.2 = moderate response, DAS28-ESR \> 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 \< -1.2 = moderate response, DAS28-ESR \> 5.1 at Week 48 and a change from BL to Week 48 \< -1.2 = moderate response, DAS28-ESR ≤ 3.2 or \> 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 ≥ -0.6 = no response, DAS28-ESR \> 5.1 at Week 48 and a change from BL to Week 48 \< -0.6 and ≥ -1.2 or ≥ -0.6 = no response.
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
ITT-M2 population
reporting Status
POSTED
time Frame
Week 48
title
Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice