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NCT02093026 · OUTCOME

Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR

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

DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour \[mm/hour\]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56\*square root (sqrt)(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR \<= 3.2 implied low disease activity (LDA) and DAS28-ESR \<2.6 = clinical remission.

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
Rituximab441

Reported measurements

LDA: 24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab441
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab24.3Not reportedNot reportedNot reportedNot reported
LDA: 24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab382
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab30.1Not reportedNot reportedNot reportedNot reported
LDA: 24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab304
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab29.3Not reportedNot reportedNot reportedNot reported
LDA: 24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab236
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab28.0Not reportedNot reportedNot reportedNot reported
LDA: 24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab172
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab23.8Not reportedNot reportedNot reportedNot reported
LDA: 24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab110
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab27.3Not reportedNot reportedNot reportedNot reported
LDA: 24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab73
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab24.7Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab441
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab11.3Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab382
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab16.8Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab304
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab17.1Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab236
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab15.7Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab172
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab15.7Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab110
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab17.3Not reportedNot reportedNot reportedNot reported
Remission: 24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab73
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab13.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        441
      units
      Participants
    title
    LDA: 24 weeks after first course
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      units
      Participants
    title
    LDA: 24 weeks after second course
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        304
      units
      Participants
    title
    LDA: 24 weeks after third course
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        28.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        236
      units
      Participants
    title
    LDA: 24 weeks after fourth course
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        172
      units
      Participants
    title
    LDA: 24 weeks after fifth course
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        27.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      units
      Participants
    title
    LDA: 24 weeks after sixth course
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        24.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    LDA: 24 weeks after seventh course
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        11.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        441
      units
      Participants
    title
    Remission: 24 weeks after first course
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        16.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      units
      Participants
    title
    Remission: 24 weeks after second course
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        17.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        304
      units
      Participants
    title
    Remission: 24 weeks after third course
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        15.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        236
      units
      Participants
    title
    Remission: 24 weeks after fourth course
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        15.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        172
      units
      Participants
    title
    Remission: 24 weeks after fifth course
denoms
  1. counts
    1. group Id
      OG000
      value
      441
    units
    Participants
description
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour \[mm/hour\]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56\*square root (sqrt)(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR \<= 3.2 implied low disease activity (LDA) and DAS28-ESR \<2.6 = clinical remission.
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 Low Disease Activity and Clinical Remission Based on DAS28-ESR
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice