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NCT02093026 · OUTCOME

American College of Rheumatology Index of Improvement (ACRn) Response

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) · Source last updated 2017-03-13

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

What was measured

The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient's assessment of disease activity; patient's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value \[either CRP or ESR\]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043.

Analysis population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.

Groups in this outcome

Rituximab

Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.

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

Analysis denominator · Participants

GroupSource count
Rituximab447

Reported measurements

24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab447
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab31.0750.188Not reportedNot reportedNot reported
24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab384
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab34.1558.769Not reportedNot reportedNot reported
24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab310
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab36.9344.912Not reportedNot reportedNot reported
24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab245
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab39.5939.393Not reportedNot reportedNot reported
24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab175
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab33.7648.309Not reportedNot reportedNot reported
24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab110
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab29.7457.197Not reportedNot reportedNot reported
24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab74
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab24.8751.336Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.188
        value
        31.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        447
      units
      Participants
    title
    24 weeks after first course
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.769
        value
        34.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      units
      Participants
    title
    24 weeks after second course
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.912
        value
        36.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        310
      units
      Participants
    title
    24 weeks after third course
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.393
        value
        39.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        245
      units
      Participants
    title
    24 weeks after fourth course
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.309
        value
        33.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        175
      units
      Participants
    title
    24 weeks after fifth course
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.197
        value
        29.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      units
      Participants
    title
    24 weeks after sixth course
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.336
        value
        24.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    24 weeks after seventh course
denoms
  1. counts
    1. group Id
      OG000
      value
      447
    units
    Participants
description
The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient's assessment of disease activity; patient's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value \[either CRP or ESR\]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
    id
    OG000
    title
    Rituximab
param Type
MEAN
population Description
ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
reporting Status
POSTED
time Frame
24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)
title
American College of Rheumatology Index of Improvement (ACRn) Response
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice