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NCT00721123 · OUTCOME

Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
through 264 Weeks

What was measured

Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis. FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points.

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 24523
Week 48482
Week 108444
Week 156414
Week 204390
Week 264370

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 2466.0Not reportedNot reportedNot reportedNot reported
Week 4858.7Not reportedNot reportedNot reportedNot reported
Week 10861.5Not reportedNot reportedNot reportedNot reported
Week 15662.3Not reportedNot reportedNot reportedNot reported
Week 20460.0Not reportedNot reportedNot reportedNot reported
Week 26462.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        66.0
      2. group Id
        OG001
        value
        58.7
      3. group Id
        OG002
        value
        61.5
      4. group Id
        OG003
        value
        62.3
      5. group Id
        OG004
        value
        60.0
      6. group Id
        OG005
        value
        62.2
denoms
  1. counts
    1. group Id
      OG000
      value
      523
    2. group Id
      OG001
      value
      482
    3. group Id
      OG002
      value
      444
    4. group Id
      OG003
      value
      414
    5. group Id
      OG004
      value
      390
    6. group Id
      OG005
      value
      370
    units
    Participants
description
Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis. FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points.
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
NUMBER
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
Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice