Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02093026 · OUTCOME

Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'

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 (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to less than or equal to (≤) 5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1.

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
Rituximab436

Reported measurements

Moderate: 24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab436
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab57.8Not reportedNot reportedNot reportedNot reported
Moderate: 24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab378
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab58.5Not reportedNot reportedNot reportedNot reported
Moderate: 24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab299
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab59.5Not reportedNot reportedNot reportedNot reported
Moderate: 24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab233
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab60.9Not reportedNot reportedNot reportedNot reported
Moderate: 24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab169
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab62.1Not reportedNot reportedNot reportedNot reported
Moderate: 24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab107
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab57.0Not reportedNot reportedNot reportedNot reported
Moderate: 24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab70
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab60.0Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after first course

Analysis denominator · Participants

GroupSource count
Rituximab436
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab24.3Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after second course

Analysis denominator · Participants

GroupSource count
Rituximab378
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab30.4Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after third course

Analysis denominator · Participants

GroupSource count
Rituximab299
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab29.1Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after fourth course

Analysis denominator · Participants

GroupSource count
Rituximab233
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab27.9Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after fifth course

Analysis denominator · Participants

GroupSource count
Rituximab169
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab24.3Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after sixth course

Analysis denominator · Participants

GroupSource count
Rituximab107
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab27.1Not reportedNot reportedNot reportedNot reported
Good: 24 weeks after seventh course

Analysis denominator · Participants

GroupSource count
Rituximab70
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab25.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        57.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        436
      units
      Participants
    title
    Moderate: 24 weeks after first course
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        58.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        378
      units
      Participants
    title
    Moderate: 24 weeks after second course
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        59.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        299
      units
      Participants
    title
    Moderate: 24 weeks after third course
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        60.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        233
      units
      Participants
    title
    Moderate: 24 weeks after fourth course
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        62.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        169
      units
      Participants
    title
    Moderate: 24 weeks after fifth course
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        57.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Moderate: 24 weeks after sixth course
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        60.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        70
      units
      Participants
    title
    Moderate: 24 weeks after seventh course
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        24.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        436
      units
      Participants
    title
    Good: 24 weeks after first course
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        30.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        378
      units
      Participants
    title
    Good: 24 weeks after second course
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        29.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        299
      units
      Participants
    title
    Good: 24 weeks after third course
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        27.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        233
      units
      Participants
    title
    Good: 24 weeks after fourth course
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        24.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        169
      units
      Participants
    title
    Good: 24 weeks after fifth course
denoms
  1. counts
    1. group Id
      OG000
      value
      436
    units
    Participants
description
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to less than or equal to (≤) 5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1.
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 European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice