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NCT00468546 · OUTCOME

Number of Participants With Categorical Change From Baseline in the Physical Component Scores of SF-36

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From Baseline (Day 1) to Week 24

What was measured

The SF-36 determined participants' overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on physical component were summed and averaged (range 0 \[worst\] to 100 \[best\]); If participants' had shown change from baseline in physical health component score \>5.42, it was considered as improved; score between -5.42 to 5.42 was considered as unchanged, and score \< -5.42 was considered as worsened. Change from Baseline = difference between the score of physical component at Week 24 and the score at Baseline.

Analysis population: The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.

Groups in this outcome

Placebo Plus Methotrexate

Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.

Rituximab Plus Methotrexate

Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.

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

Analysis denominator · Participants

GroupSource count
Placebo Plus Methotrexate197
Rituximab Plus Methotrexate294

Reported measurements

Improved
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Methotrexate25Not reportedNot reportedNot reportedNot reported
Rituximab Plus Methotrexate141Not reportedNot reportedNot reportedNot reported
Unchanged
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Methotrexate158Not reportedNot reportedNot reportedNot reported
Rituximab Plus Methotrexate136Not reportedNot reportedNot reportedNot reported
Worsened
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Methotrexate14Not reportedNot reportedNot reportedNot reported
Rituximab Plus Methotrexate17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        141
    title
    Improved
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        158
      2. group Id
        OG001
        value
        136
    title
    Unchanged
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        17
    title
    Worsened
denoms
  1. counts
    1. group Id
      OG000
      value
      197
    2. group Id
      OG001
      value
      294
    units
    Participants
description
The SF-36 determined participants' overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on physical component were summed and averaged (range 0 \[worst\] to 100 \[best\]); If participants' had shown change from baseline in physical health component score \>5.42, it was considered as improved; score between -5.42 to 5.42 was considered as unchanged, and score \< -5.42 was considered as worsened. Change from Baseline = difference between the score of physical component at Week 24 and the score at Baseline.
groups
  1. description
    Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
    id
    OG000
    title
    Placebo Plus Methotrexate
  2. description
    Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
    id
    OG001
    title
    Rituximab Plus Methotrexate
param Type
NUMBER
population Description
The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.
reporting Status
POSTED
time Frame
From Baseline (Day 1) to Week 24
title
Number of Participants With Categorical Change From Baseline in the Physical Component Scores of SF-36
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice