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NCT02093026 · OUTCOME

Percentage of Participants With ACR50 and ACR70 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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
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

A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to 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

ACR50: 24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab447
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab39.4Not reportedNot reportedNot reportedNot reported
ACR50: 24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab384
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab41.9Not reportedNot reportedNot reportedNot reported
ACR50: 24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab310
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab44.8Not reportedNot reportedNot reportedNot reported
ACR50: 24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab245
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab46.9Not reportedNot reportedNot reportedNot reported
ACR50: 24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab175
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab40.0Not reportedNot reportedNot reportedNot reported
ACR50: 24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab110
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab40.0Not reportedNot reportedNot reportedNot reported
ACR50: 24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab74
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab36.5Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab447
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab16.3Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab384
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab21.6Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab310
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab20.0Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab245
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab20.0Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab175
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab18.9Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab110
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab20.9Not reportedNot reportedNot reportedNot reported
ACR70: 24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab74
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab18.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        39.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        447
      units
      Participants
    title
    ACR50: 24 weeks after first course
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      units
      Participants
    title
    ACR50: 24 weeks after second course
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        44.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        310
      units
      Participants
    title
    ACR50: 24 weeks after third course
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        46.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        245
      units
      Participants
    title
    ACR50: 24 weeks after fourth course
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        40.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        175
      units
      Participants
    title
    ACR50: 24 weeks after fifth course
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        40.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      units
      Participants
    title
    ACR50: 24 weeks after sixth course
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        36.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    ACR50: 24 weeks after seventh course
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        16.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        447
      units
      Participants
    title
    ACR70: 24 weeks after first course
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        21.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      units
      Participants
    title
    ACR70: 24 weeks after second course
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        310
      units
      Participants
    title
    ACR70: 24 weeks after third course
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        245
      units
      Participants
    title
    ACR70: 24 weeks after fourth course
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        18.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        175
      units
      Participants
    title
    ACR70: 24 weeks after fifth course
denoms
  1. counts
    1. group Id
      OG000
      value
      447
    units
    Participants
description
A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043.
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
NUMBER
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
Percentage of Participants With ACR50 and ACR70 Response
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice