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NCT02097745 · OUTCOME

Change From Baseline in the Disease Activity Score 28 (DAS28)

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
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
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 a higher score represents higher disease activity. A negative change score indicates improvement. 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 (n = 304)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-2.321.336Not reportedNot reportedNot reported
Retreatment 2 (n = 258)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-2.771.302Not reportedNot reportedNot reported
Retreatment 3 (n = 227)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-3.011.388Not reportedNot reportedNot reported
Retreatment 4 (n = 168)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-3.051.537Not reportedNot reportedNot reported
Retreatment 5 (n = 132)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-3.151.536Not reportedNot reportedNot reported
Retreatment 6 (n = 87)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-2.961.540Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.336
        value
        -2.32
    title
    Retreatment 1 (n = 304)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.302
        value
        -2.77
    title
    Retreatment 2 (n = 258)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.388
        value
        -3.01
    title
    Retreatment 3 (n = 227)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.537
        value
        -3.05
    title
    Retreatment 4 (n = 168)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.536
        value
        -3.15
    title
    Retreatment 5 (n = 132)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.540
        value
        -2.96
    title
    Retreatment 6 (n = 87)
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 a higher score represents higher disease activity. A negative change score indicates improvement. The first retreatment may have occurred in the precursor study WA17042.
dispersion Type
Standard Deviation
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
MEAN
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
Change From Baseline in the Disease Activity Score 28 (DAS28)
type
SECONDARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice