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NCT02097745 · OUTCOME

Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies · Source last updated 2016-11-03

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
Baseline to the end of the retreatment period (up to 7 years, 6 months)

What was measured

Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2. The first retreatment may have occurred in the precursor study WA17042.

Analysis population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.

Groups in this outcome

Rituximab

Participants received rituximab 1 g intravenously (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, given as either a single dose or as divided daily doses.

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

Analysis denominator · Participants

GroupSource count
Rituximab335

Reported measurements

Retreatment 1: Good Response (n = 304)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab17.1Not reportedNot reportedNot reportedNot reported
Retreatment 1: Moderate Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab64.8Not reportedNot reportedNot reportedNot reported
Retreatment 1: No Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab18.1Not reportedNot reportedNot reportedNot reported
Retreatment 2: Good Response (n = 258)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab27.5Not reportedNot reportedNot reportedNot reported
Retreatment 2: Moderate Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab64.3Not reportedNot reportedNot reportedNot reported
Retreatment 2: No Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab8.1Not reportedNot reportedNot reportedNot reported
Retreatment 3: Good Response (n = 227)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab36.6Not reportedNot reportedNot reportedNot reported
Retreatment 3: Moderate Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab53.3Not reportedNot reportedNot reportedNot reported
Retreatment 3: No Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab10.1Not reportedNot reportedNot reportedNot reported
Retreatment 4: Good Response (n = 168)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab33.9Not reportedNot reportedNot reportedNot reported
Retreatment 4: Moderate Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab58.9Not reportedNot reportedNot reportedNot reported
Retreatment 4: No Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab7.1Not reportedNot reportedNot reportedNot reported
Retreatment 5: Good Response (n = 132)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab36.4Not reportedNot reportedNot reportedNot reported
Retreatment 5: Moderate Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab54.5Not reportedNot reportedNot reportedNot reported
Retreatment 5: No Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab9.1Not reportedNot reportedNot reportedNot reported
Retreatment 6: Good Response (n = 87)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab33.3Not reportedNot reportedNot reportedNot reported
Retreatment 6: Moderate Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab59.8Not reportedNot reportedNot reportedNot reported
Retreatment 6: No Response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab6.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17.1
    title
    Retreatment 1: Good Response (n = 304)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        64.8
    title
    Retreatment 1: Moderate Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18.1
    title
    Retreatment 1: No Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        27.5
    title
    Retreatment 2: Good Response (n = 258)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        64.3
    title
    Retreatment 2: Moderate Response
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8.1
    title
    Retreatment 2: No Response
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        36.6
    title
    Retreatment 3: Good Response (n = 227)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        53.3
    title
    Retreatment 3: Moderate Response
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        10.1
    title
    Retreatment 3: No Response
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        33.9
    title
    Retreatment 4: Good Response (n = 168)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        58.9
    title
    Retreatment 4: Moderate Response
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        7.1
    title
    Retreatment 4: No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    units
    Participants
description
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2. The first retreatment may have occurred in the precursor study WA17042.
groups
  1. description
    Participants received rituximab 1 g intravenously (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, given as either a single dose or as divided daily doses.
    id
    OG000
    title
    Rituximab
param Type
NUMBER
population Description
Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
reporting Status
POSTED
time Frame
Baseline to the end of the retreatment period (up to 7 years, 6 months)
title
Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice