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NCT02097745 · OUTCOME

Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) 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 FACIT-F is a 13-item participant self-reporting 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 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 = 321)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab10.79010.7934Not reportedNot reportedNot reported
Retreatment 2 (n = 272)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab6.3909.1312Not reportedNot reportedNot reported
Retreatment 3 (n = 232)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab7.0759.8208Not reportedNot reportedNot reported
Retreatment 4 (n = 176)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab6.77010.4043Not reportedNot reportedNot reported
Retreatment 5 (n = 131)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab8.03010.4571Not reportedNot reportedNot reported
Retreatment 6 (n = 89)
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab5.4299.4251Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.7934
        value
        10.790
    title
    Retreatment 1 (n = 321)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.1312
        value
        6.390
    title
    Retreatment 2 (n = 272)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.8208
        value
        7.075
    title
    Retreatment 3 (n = 232)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.4043
        value
        6.770
    title
    Retreatment 4 (n = 176)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.4571
        value
        8.030
    title
    Retreatment 5 (n = 131)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.4251
        value
        5.429
    title
    Retreatment 6 (n = 89)
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    units
    Participants
description
The FACIT-F is a 13-item participant self-reporting 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 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 Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice