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NCT00299104 · OUTCOME

Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis · Source last updated 2017-07-28

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
Baseline, Week 52

What was measured

No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.

Analysis population: Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.

Groups in this outcome

Placebo + Methotrexate

Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.

Rituximab (0.5 g x 2) + Methotrexate

Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6

Rituximab (1.0 g x 2) + Methotrexate

Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo + Methotrexate232
Rituximab (0.5 g x 2) + Methotrexate239
Rituximab (1.0 g x 2) + Methotrexate244

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Methotrexate54.7Not reportedNot reportedNot reportedNot reported
Rituximab (0.5 g x 2) + Methotrexate59.0Not reportedNot reportedNot reportedNot reported
Rituximab (1.0 g x 2) + Methotrexate66.8Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Description
    Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3752
    p Value Comment
    This was a secondary endpoint in a hierarchical testing structure.
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Pct Value
    95
    group Description
    Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0081
    p Value Comment
    This was a secondary endpoint in a hierarchical testing structure.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3752
    p Value Comment
    This was a secondary endpoint in a hierarchical testing structure.
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Pct Value
    95
    group Description
    Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0081
    p Value Comment
    This was a secondary endpoint in a hierarchical testing structure.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        54.7
      2. group Id
        OG001
        value
        59.0
      3. group Id
        OG002
        value
        66.8
denoms
  1. counts
    1. group Id
      OG000
      value
      232
    2. group Id
      OG001
      value
      239
    3. group Id
      OG002
      value
      244
    units
    Participants
description
No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.
groups
  1. description
    Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
    id
    OG000
    title
    Placebo + Methotrexate
  2. description
    Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
    id
    OG001
    title
    Rituximab (0.5 g x 2) + Methotrexate
  3. description
    Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
    id
    OG002
    title
    Rituximab (1.0 g x 2) + Methotrexate
param Type
NUMBER
population Description
Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.
reporting Status
POSTED
time Frame
Baseline, Week 52
title
Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice