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NCT00720798 · OUTCOME

Percentage of Participants With Concomitant Oral Corticosteroid 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 the end of the study (up to 7 years, 7 months)

What was measured

Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count. The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.

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.

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

0 - 6 Months, n = 2067
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab55.8Not reportedNot reportedNot reportedNot reported
6 - 12 Months, n = 2041
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab55.3Not reportedNot reportedNot reportedNot reported
12 - 18 Months, n = 1944
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab54.6Not reportedNot reportedNot reportedNot reported
18 - 24 Months, n = 1832
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab54.3Not reportedNot reportedNot reportedNot reported
24 - 30 Months, n = 1753
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab53.2Not reportedNot reportedNot reportedNot reported
30 - 36 Months, n = 1677
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab52.9Not reportedNot reportedNot reportedNot reported
36 - 42 Months, n = 1620
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab51.3Not reportedNot reportedNot reportedNot reported
42 - 48 Months, n = 1568
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab50.4Not reportedNot reportedNot reportedNot reported
48 - 54 Months, n = 1516
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab50.6Not reportedNot reportedNot reportedNot reported
54 - 60 Months, n = 1475
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab50.1Not reportedNot reportedNot reportedNot reported
60 - 66 Months, n = 1423
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab49.2Not reportedNot reportedNot reportedNot reported
66 - 72 Months, n = 1342
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab48.4Not reportedNot reportedNot reportedNot reported
72 - 78 Months, n = 788
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab48.7Not reportedNot reportedNot reportedNot reported
78 - 84 Months, n = 62
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab72.6Not reportedNot reportedNot reportedNot reported
84 - 90 Months, n = 34
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab79.4Not reportedNot reportedNot reportedNot reported
90 - 96 Months, n = 10
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab70.0Not reportedNot reportedNot reportedNot reported
96 - 102 Months, n = 2
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        55.8
    title
    0 - 6 Months, n = 2067
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        55.3
    title
    6 - 12 Months, n = 2041
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        54.6
    title
    12 - 18 Months, n = 1944
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        54.3
    title
    18 - 24 Months, n = 1832
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        53.2
    title
    24 - 30 Months, n = 1753
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        52.9
    title
    30 - 36 Months, n = 1677
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        51.3
    title
    36 - 42 Months, n = 1620
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        50.4
    title
    42 - 48 Months, n = 1568
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        50.6
    title
    48 - 54 Months, n = 1516
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        50.1
    title
    54 - 60 Months, n = 1475
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        49.2
    title
    60 - 66 Months, n = 1423
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        48.4
    title
    66 - 72 Months, n = 1342
denoms
  1. counts
    1. group Id
      OG000
      value
      2067
    units
    Participants
description
Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count. The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.
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.
time Frame
Baseline to the end of the study (up to 7 years, 7 months)
title
Percentage of Participants With Concomitant Oral Corticosteroid Therapy
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice