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NCT00422383 · OUTCOME

Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48

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
MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
BL, Week 48

What was measured

DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* participant's global assessment of disease activity (GH)\]. DAS28-ESR ≥ 5.1 = high disease activity, DAS28-ESR less than or equal to (≤) 3.2 = low disease activity, DAS28-ESR less than (\<) 2.6 = remission.

Analysis population: ITT-M2 population. Two participants from the Low Dose group and 1 participant from the Escalated Dose group were not evaluated for this outcome measure.

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 + Methotrexate132
Rituximab Escalated Dose + Methotrexate118
Rituximab High Dose + Methotrexate93

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate-2.13Not reported-2.38-1.87Not reported
Rituximab Escalated Dose + Methotrexate-2.19Not reported-2.45-1.92Not reported
Rituximab High Dose + Methotrexate-2.42Not reported-2.71-2.12Not 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
    0.7127
    p Value Comment
    Stratified by region, prior biologic use, RF status and treatment.
    statistical Method
    ANOVA
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1018
    p Value Comment
    Stratified by region, prior biologic use, RF status and treatment.
    statistical Method
    ANOVA
    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
    0.7127
    p Value Comment
    Stratified by region, prior biologic use, RF status and treatment.
    statistical Method
    ANOVA
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1018
    p Value Comment
    Stratified by region, prior biologic use, RF status and treatment.
    statistical Method
    ANOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.38
        upper Limit
        -1.87
        value
        -2.13
      2. group Id
        OG001
        lower Limit
        -2.45
        upper Limit
        -1.92
        value
        -2.19
      3. group Id
        OG002
        lower Limit
        -2.71
        upper Limit
        -2.12
        value
        -2.42
denoms
  1. counts
    1. group Id
      OG000
      value
      132
    2. group Id
      OG001
      value
      118
    3. group Id
      OG002
      value
      93
    units
    Participants
description
DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* participant's global assessment of disease activity (GH)\]. DAS28-ESR ≥ 5.1 = high disease activity, DAS28-ESR less than or equal to (≤) 3.2 = low disease activity, DAS28-ESR less than (\<) 2.6 = remission.
dispersion Type
95% Confidence Interval
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
MEAN
population Description
ITT-M2 population. Two participants from the Low Dose group and 1 participant from the Escalated Dose group were not evaluated for this outcome measure.
reporting Status
POSTED
time Frame
BL, Week 48
title
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice