Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00266227 · OUTCOME

Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) 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/hour (mm/hr)
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 48

What was measured

Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.

Analysis population: Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.

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 Retreatment315
Arm B: Placebo Retreatment157

Reported measurements

Source class 1
Values in millimeter/hour (mm/hr) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A: Rituximab Retreatment-15.025.03Not reportedNot reportedNot reported
Arm B: Placebo Retreatment-10.924.00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.03
        value
        -15.0
      2. group Id
        OG001
        spread
        24.00
        value
        -10.9
denoms
  1. counts
    1. group Id
      OG000
      value
      315
    2. group Id
      OG001
      value
      157
    units
    Participants
description
Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. 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
Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.
reporting Status
POSTED
time Frame
Baseline, Week 48
title
Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48
type
SECONDARY
unit Of Measure
millimeter/hour (mm/hr)

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

Preserved source evidence · Not medical advice