Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02097745 · OUTCOME

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

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 HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.

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 = 320)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-0.510.569Not reportedNot reportedNot reported
Retreatment 2 (n = 267)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-0.540.569Not reportedNot reportedNot reported
Retreatment 3 (n = 234)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-0.560.601Not reportedNot reportedNot reported
Retreatment 4 (n = 175)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-0.550.603Not reportedNot reportedNot reported
Retreatment 5 (n = 136)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-0.600.647Not reportedNot reportedNot reported
Retreatment 6 (n = 92)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab-0.550.653Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.569
        value
        -0.51
    title
    Retreatment 1 (n = 320)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.569
        value
        -0.54
    title
    Retreatment 2 (n = 267)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.601
        value
        -0.56
    title
    Retreatment 3 (n = 234)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.603
        value
        -0.55
    title
    Retreatment 4 (n = 175)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.647
        value
        -0.60
    title
    Retreatment 5 (n = 136)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.653
        value
        -0.55
    title
    Retreatment 6 (n = 92)
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    units
    Participants
description
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
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 Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
type
SECONDARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice