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NCT00720798 · OUTCOME

Percentage of Participants Who Changed From Monotherapy to Combination Therapy

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 296

What was measured

Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.

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 from the core study WA17824 are 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
Tocilizumab243

Reported measurements

Week 8
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab1.2Not reportedNot reportedNot reportedNot reported
Week 12
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 24
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab15.6Not reportedNot reportedNot reportedNot reported
Week 28
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab7.0Not reportedNot reportedNot reportedNot reported
Week 32
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab2.5Not reportedNot reportedNot reportedNot reported
Week 36
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab1.6Not reportedNot reportedNot reportedNot reported
Week 40
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 44
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 48
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab1.6Not reportedNot reportedNot reportedNot reported
Week 52
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 54
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 64
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab1.2Not reportedNot reportedNot reportedNot reported
Week 68
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 72
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 76
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 88
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 96
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab1.2Not reportedNot reportedNot reportedNot reported
Week 100
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 104
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 108
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 112
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 116
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 120
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 140
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 152
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 184
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 196
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 200
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Week 292
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.4Not reportedNot reportedNot reportedNot reported
Week 296
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.2
    title
    Week 8
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
    title
    Week 12
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15.6
    title
    Week 24
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7.0
    title
    Week 28
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2.5
    title
    Week 32
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
    title
    Week 36
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
    title
    Week 40
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
    title
    Week 44
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
    title
    Week 48
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
    title
    Week 52
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
    title
    Week 54
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1.2
    title
    Week 64
denoms
  1. counts
    1. group Id
      OG000
      value
      243
    units
    Participants
description
Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.
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 from the core study WA17824 are included in the analysis.
time Frame
Baseline to Week 296
title
Percentage of Participants Who Changed From Monotherapy to Combination Therapy
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice