Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02097745 · OUTCOME

Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission

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

The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score \< 2.6. 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: Low Disease Activity (n=314)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab17.2Not reportedNot reportedNot reportedNot reported
Retreatment 1: Remission
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab8.9Not reportedNot reportedNot reportedNot reported
Retreatment 2: Low Disease Activity (n=265)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab27.9Not reportedNot reportedNot reportedNot reported
Retreatment 2: Remission
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab15.1Not reportedNot reportedNot reportedNot reported
Retreatment 3: Low Disease Activity (n=234)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab36.8Not reportedNot reportedNot reportedNot reported
Retreatment 3: Remission
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab18.8Not reportedNot reportedNot reportedNot reported
Retreatment 4: Low Disease Activity (n=172)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab33.7Not reportedNot reportedNot reportedNot reported
Retreatment 4: Remission
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab20.9Not reportedNot reportedNot reportedNot reported
Retreatment 5: Low Disease Activity (n=135)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab36.3Not reportedNot reportedNot reportedNot reported
Retreatment 5: Remission
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab20.0Not reportedNot reportedNot reportedNot reported
Retreatment 6: Low Disease Activity (n=90)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab33.3Not reportedNot reportedNot reportedNot reported
Retreatment 6: Remission
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab15.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17.2
    title
    Retreatment 1: Low Disease Activity (n=314)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8.9
    title
    Retreatment 1: Remission
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        27.9
    title
    Retreatment 2: Low Disease Activity (n=265)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        15.1
    title
    Retreatment 2: Remission
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        36.8
    title
    Retreatment 3: Low Disease Activity (n=234)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        18.8
    title
    Retreatment 3: Remission
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        33.7
    title
    Retreatment 4: Low Disease Activity (n=172)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        20.9
    title
    Retreatment 4: Remission
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        36.3
    title
    Retreatment 5: Low Disease Activity (n=135)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    title
    Retreatment 5: Remission
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
    title
    Retreatment 6: Low Disease Activity (n=90)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        15.6
    title
    Retreatment 6: Remission
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    units
    Participants
description
The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score \< 2.6. 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 DAS28 Low Disease Activity and DAS28 Remission
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice