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NCT00721123 · OUTCOME

Participants Showing Improvement in Rheumatoid Arthritis Symptoms 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

The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire. Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms. Scores on the ACR scale may be up to ACR100 because the number after "ACR" is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score - that percentage of improvement.

Analysis population: All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab, 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 24522
Week 48480
Week 108422
Week 156413
Week 204387
Week 264367

Reported measurements

ACR20
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 2463.2Not reportedNot reportedNot reportedNot reported
Week 4876.0Not reportedNot reportedNot reportedNot reported
Week 10881.2Not reportedNot reportedNot reportedNot reported
Week 15683.3Not reportedNot reportedNot reportedNot reported
Week 20482.2Not reportedNot reportedNot reportedNot reported
Week 26483.9Not reportedNot reportedNot reportedNot reported
ACR50
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 2441.2Not reportedNot reportedNot reportedNot reported
Week 4850.6Not reportedNot reportedNot reportedNot reported
Week 10858.1Not reportedNot reportedNot reportedNot reported
Week 15659.6Not reportedNot reportedNot reportedNot reported
Week 20462.5Not reportedNot reportedNot reportedNot reported
Week 26467.8Not reportedNot reportedNot reportedNot reported
ACR70
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 2417.4Not reportedNot reportedNot reportedNot reported
Week 4827.1Not reportedNot reportedNot reportedNot reported
Week 10838.2Not reportedNot reportedNot reportedNot reported
Week 15641.9Not reportedNot reportedNot reportedNot reported
Week 20442.1Not reportedNot reportedNot reportedNot reported
Week 26445.8Not reportedNot reportedNot reportedNot reported
ACR90
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 244.8Not reportedNot reportedNot reportedNot reported
Week 485.2Not reportedNot reportedNot reportedNot reported
Week 10811.3Not reportedNot reportedNot reportedNot reported
Week 15615.3Not reportedNot reportedNot reportedNot reported
Week 20416.8Not reportedNot reportedNot reportedNot reported
Week 26419.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63.2
      2. group Id
        OG001
        value
        76.0
      3. group Id
        OG002
        value
        81.2
      4. group Id
        OG003
        value
        83.3
      5. group Id
        OG004
        value
        82.2
      6. group Id
        OG005
        value
        83.9
    title
    ACR20
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41.2
      2. group Id
        OG001
        value
        50.6
      3. group Id
        OG002
        value
        58.1
      4. group Id
        OG003
        value
        59.6
      5. group Id
        OG004
        value
        62.5
      6. group Id
        OG005
        value
        67.8
    title
    ACR50
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17.4
      2. group Id
        OG001
        value
        27.1
      3. group Id
        OG002
        value
        38.2
      4. group Id
        OG003
        value
        41.9
      5. group Id
        OG004
        value
        42.1
      6. group Id
        OG005
        value
        45.8
    title
    ACR70
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.8
      2. group Id
        OG001
        value
        5.2
      3. group Id
        OG002
        value
        11.3
      4. group Id
        OG003
        value
        15.3
      5. group Id
        OG004
        value
        16.8
      6. group Id
        OG005
        value
        19.3
    title
    ACR90
denoms
  1. counts
    1. group Id
      OG000
      value
      522
    2. group Id
      OG001
      value
      480
    3. group Id
      OG002
      value
      422
    4. group Id
      OG003
      value
      413
    5. group Id
      OG004
      value
      387
    6. group Id
      OG005
      value
      367
    units
    Participants
description
The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire. Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms. Scores on the ACR scale may be up to ACR100 because the number after "ACR" is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score - that percentage of improvement.
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, with a score at the given time point.
reporting Status
POSTED
time Frame
through 264 Weeks
title
Participants Showing Improvement in Rheumatoid Arthritis Symptoms 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