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NCT00266227 · OUTCOME

Percentage of Retreated Subjects Achieving DAS28-ESR Remission 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Week 48

What was measured

DAS28-ESR remission was defined as a DAS28-ESR \< 2.6

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 Re-treatment

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 Re-treatment

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 Re-treatment317
Arm B: Placebo Re-treatment157

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Rituximab Re-treatment10.4Not reportedNot reportedNot reportedNot reported
Arm B: Placebo Re-treatment8.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10.4
      2. group Id
        OG001
        value
        8.9
denoms
  1. counts
    1. group Id
      OG000
      value
      317
    2. group Id
      OG001
      value
      157
    units
    Participants
description
DAS28-ESR remission was defined as a DAS28-ESR \< 2.6
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 Re-treatment
  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 Re-treatment
param Type
NUMBER
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
Week 48
title
Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice