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NCT00299104 · OUTCOME

Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline 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

The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction. Improved:HAQ-DI score change \<=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score =\> 0.22

Analysis population: Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.

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 + Methotrexate249
Rituximab (0.5 g x 2) + Methotrexate249
Rituximab (1.0 g x 2) + Methotrexate250

Reported measurements

Improved
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Methotrexate77.1Not reportedNot reportedNot reportedNot reported
Rituximab (0.5 g x 2) + Methotrexate86.7Not reportedNot reportedNot reportedNot reported
Rituximab (1.0 g x 2) + Methotrexate86.8Not reportedNot reportedNot reportedNot reported
Unchanged
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Methotrexate14.1Not reportedNot reportedNot reportedNot reported
Rituximab (0.5 g x 2) + Methotrexate8.8Not reportedNot reportedNot reportedNot reported
Rituximab (1.0 g x 2) + Methotrexate8.0Not reportedNot reportedNot reportedNot reported
Worsened
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Methotrexate8.4Not reportedNot reportedNot reportedNot reported
Rituximab (0.5 g x 2) + Methotrexate3.6Not reportedNot reportedNot reportedNot reported
Rituximab (1.0 g x 2) + Methotrexate4.4Not reportedNot reportedNot reportedNot reported
Not Assessable
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Methotrexate0.4Not reportedNot reportedNot reportedNot reported
Rituximab (0.5 g x 2) + Methotrexate0.8Not reportedNot reportedNot reportedNot reported
Rituximab (1.0 g x 2) + Methotrexate0.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        77.1
      2. group Id
        OG001
        value
        86.7
      3. group Id
        OG002
        value
        86.8
    title
    Improved
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14.1
      2. group Id
        OG001
        value
        8.8
      3. group Id
        OG002
        value
        8.0
    title
    Unchanged
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8.4
      2. group Id
        OG001
        value
        3.6
      3. group Id
        OG002
        value
        4.4
    title
    Worsened
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
      2. group Id
        OG001
        value
        0.8
      3. group Id
        OG002
        value
        0.8
    title
    Not Assessable
denoms
  1. counts
    1. group Id
      OG000
      value
      249
    2. group Id
      OG001
      value
      249
    3. group Id
      OG002
      value
      250
    units
    Participants
description
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction. Improved:HAQ-DI score change \<=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score =\> 0.22
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
Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.
reporting Status
POSTED
time Frame
Baseline, Week 52
title
Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice