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NCT00266227 · OUTCOME

Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2013-10-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
millimeter (mm)
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 48

What was measured

A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.

Analysis population: Intent-to-treat population includes all participants randomized to Retreatment.

Groups in this outcome

Arm A: Rituximab Retreatment

1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.

Arm B: Placebo Retreatment

1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.

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

Analysis denominator · Participants

GroupSource count
Arm A: Rituximab Retreatment318
Arm B: Placebo Retreatment157

Reported measurements

Source class 1
Values in millimeter (mm) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A: Rituximab Retreatment-31.527.00Not reportedNot reportedNot reported
Arm B: Placebo Retreatment-25.529.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.00
        value
        -31.5
      2. group Id
        OG001
        spread
        29.59
        value
        -25.5
denoms
  1. counts
    1. group Id
      OG000
      value
      318
    2. group Id
      OG001
      value
      157
    units
    Participants
description
A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.
dispersion Type
Standard Deviation
groups
  1. description
    1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
    id
    OG000
    title
    Arm A: Rituximab Retreatment
  2. description
    1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
    id
    OG001
    title
    Arm B: Placebo Retreatment
param Type
MEAN
population Description
Intent-to-treat population includes all participants randomized to Retreatment.
reporting Status
POSTED
time Frame
Baseline, Week 48
title
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48
type
SECONDARY
unit Of Measure
millimeter (mm)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice