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NCT00721123 · OUTCOME

Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks

A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis · Source last updated 2013-11-28

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
through 264 Weeks

What was measured

The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement.

Analysis population: All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.

Groups in this outcome

Week 24

Participants with scores at 24 weeks post-baseline.

Week 48

Participants with scores at 48 weeks post-baseline.

Week 108

Participants with scores at 108 weeks post-baseline.

Week 156

Participants with scores at 156 weeks post-baseline.

Week 204

Participants with scores at 204 weeks post-baseline.

Week 264

Participants with scores at 264 weeks post-baseline.

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

Analysis denominator · Participants

GroupSource count
Week 24445
Week 48408
Week 108376
Week 156349
Week 204332
Week 264316

Reported measurements

Source class 1
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Week 24-0.490.582Not reportedNot reportedNot reported
Week 48-0.530.614Not reportedNot reportedNot reported
Week 108-0.590.636Not reportedNot reportedNot reported
Week 156-0.610.655Not reportedNot reportedNot reported
Week 204-0.650.661Not reportedNot reportedNot reported
Week 264-0.620.693Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.582
        value
        -0.49
      2. group Id
        OG001
        spread
        0.614
        value
        -0.53
      3. group Id
        OG002
        spread
        0.636
        value
        -0.59
      4. group Id
        OG003
        spread
        0.655
        value
        -0.61
      5. group Id
        OG004
        spread
        0.661
        value
        -0.65
      6. group Id
        OG005
        spread
        0.693
        value
        -0.62
denoms
  1. counts
    1. group Id
      OG000
      value
      445
    2. group Id
      OG001
      value
      408
    3. group Id
      OG002
      value
      376
    4. group Id
      OG003
      value
      349
    5. group Id
      OG004
      value
      332
    6. group Id
      OG005
      value
      316
    units
    Participants
description
The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with scores at 24 weeks post-baseline.
    id
    OG000
    title
    Week 24
  2. description
    Participants with scores at 48 weeks post-baseline.
    id
    OG001
    title
    Week 48
  3. description
    Participants with scores at 108 weeks post-baseline.
    id
    OG002
    title
    Week 108
  4. description
    Participants with scores at 156 weeks post-baseline.
    id
    OG003
    title
    Week 156
  5. description
    Participants with scores at 204 weeks post-baseline.
    id
    OG004
    title
    Week 204
  6. description
    Participants with scores at 264 weeks post-baseline.
    id
    OG005
    title
    Week 264
param Type
MEAN
population Description
All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.
reporting Status
POSTED
time Frame
through 264 Weeks
title
Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks
type
SECONDARY
unit Of Measure
Units on a Scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice