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NCT00720798 · OUTCOME

Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, 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
MEAN
Unit
Joints
Interval / dispersion
Standard Deviation
Time frame
Baseline to Week 264

What was measured

The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.

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

Baseline SJC (n = 2047)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab17.411.96Not reportedNot reportedNot reported
Week 24 SJC (n = 2010)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab8.29.43Not reportedNot reportedNot reported
Week 48 SJC (n = 1924)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab6.48.75Not reportedNot reportedNot reported
Week 108 SJC (n = 1692)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab4.26.69Not reportedNot reportedNot reported
Week 156 SJC (n = 1580)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab4.07.09Not reportedNot reportedNot reported
Week 204 SJC (n = 1482)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab3.25.96Not reportedNot reportedNot reported
Week 264 SJC (n = 1352)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab2.95.85Not reportedNot reportedNot reported
Baseline TJC (n = 2047)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab27.316.97Not reportedNot reportedNot reported
Week 24 TJC (n = 2010)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab12.814.10Not reportedNot reportedNot reported
Week 48 TJC (n = 1924)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab10.312.99Not reportedNot reportedNot reported
Week 108 TJC (n = 1692)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab7.811.04Not reportedNot reportedNot reported
Week 156 TJC (n = 1580)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab7.211.03Not reportedNot reportedNot reported
Week 204 TJC (n = 1482)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab6.19.83Not reportedNot reportedNot reported
Week 264 TJC (n = 1352)
Values in Joints · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Tocilizumab5.69.48Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.96
        value
        17.4
    title
    Baseline SJC (n = 2047)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.43
        value
        8.2
    title
    Week 24 SJC (n = 2010)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.75
        value
        6.4
    title
    Week 48 SJC (n = 1924)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.69
        value
        4.2
    title
    Week 108 SJC (n = 1692)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.09
        value
        4.0
    title
    Week 156 SJC (n = 1580)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.96
        value
        3.2
    title
    Week 204 SJC (n = 1482)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.85
        value
        2.9
    title
    Week 264 SJC (n = 1352)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.97
        value
        27.3
    title
    Baseline TJC (n = 2047)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.10
        value
        12.8
    title
    Week 24 TJC (n = 2010)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.99
        value
        10.3
    title
    Week 48 TJC (n = 1924)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.04
        value
        7.8
    title
    Week 108 TJC (n = 1692)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.03
        value
        7.2
    title
    Week 156 TJC (n = 1580)
denoms
  1. counts
    1. group Id
      OG000
      value
      2067
    units
    Participants
description
The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.
dispersion Type
Standard Deviation
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
MEAN
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
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
type
SECONDARY
unit Of Measure
Joints

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Preserved source evidence · Not medical advice