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NCT00720798 · OUTCOME

Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, 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

A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

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 48 (n = 1937)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab8.5Not reportedNot reportedNot reportedNot reported
Week 96 (n = 1745)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab16.2Not reportedNot reportedNot reportedNot reported
Week 144 (n = 1615)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab20.9Not reportedNot reportedNot reportedNot reported
Week 192 (n = 1514)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab22.9Not reportedNot reportedNot reportedNot reported
Week 264 (n = 1358)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab24.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8.5
    title
    Week 48 (n = 1937)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16.2
    title
    Week 96 (n = 1745)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20.9
    title
    Week 144 (n = 1615)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        22.9
    title
    Week 192 (n = 1514)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        24.9
    title
    Week 264 (n = 1358)
denoms
  1. counts
    1. group Id
      OG000
      value
      2067
    units
    Participants
description
A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
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 Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice