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NCT00720798 · OUTCOME

Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30

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 Week 264

What was measured

The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.

Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.

Groups in this outcome

Tocilizumab

Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Tocilizumab2067

Reported measurements

Week 24 (n = 1984)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab59.5Not reportedNot reportedNot reportedNot reported
Week 36 (n = 1839)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab52.5Not reportedNot reportedNot reportedNot reported
Week 48 (n = 1803)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab56.0Not reportedNot reportedNot reportedNot reported
Week 108 (n = 1616)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab56.8Not reportedNot reportedNot reportedNot reported
Week 156 (n = 1513)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab56.3Not reportedNot reportedNot reportedNot reported
Week 204 (n = 1422)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab56.4Not reportedNot reportedNot reportedNot reported
Week 264 (n = 1320)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab61.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59.5
    title
    Week 24 (n = 1984)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        52.5
    title
    Week 36 (n = 1839)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        56.0
    title
    Week 48 (n = 1803)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        56.8
    title
    Week 108 (n = 1616)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        56.3
    title
    Week 156 (n = 1513)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        56.4
    title
    Week 204 (n = 1422)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        61.9
    title
    Week 264 (n = 1320)
denoms
  1. counts
    1. group Id
      OG000
      value
      2067
    units
    Participants
description
The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.
groups
  1. description
    Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    id
    OG000
    title
    Tocilizumab
param Type
NUMBER
population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
time Frame
Baseline to Week 264
title
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice