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NCT00468546 · OUTCOME

Number of Participants With Good, Moderate, or no European League Against Rheumatism Responses at Week 24

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Week 24

What was measured

European League Against Rheumatism (EULAR) response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. At a given visit, participants with a DAS28 score of \< 3.2 are considered good responders if the change from baseline in their DAS28 score is \>1.2. Participants with a DAS28 score \>= 3.2 to 5.1 are considered moderate responders if the change from baseline in their DAS28 score is \<=1.2 to \>=0.6. Participants with DAS28 score \>5.1 are considered non-responders if the change from baseline in their DAS28 score is \<=1.2 to \>=0.6.

Analysis population: The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.

Groups in this outcome

Placebo Plus Methotrexate

Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.

Rituximab Plus Methotrexate

Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.

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 Plus Methotrexate201
Rituximab Plus Methotrexate298

Reported measurements

No response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Methotrexate157Not reportedNot reportedNot reportedNot reported
Rituximab Plus Methotrexate105Not reportedNot reportedNot reportedNot reported
Moderate response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Methotrexate40Not reportedNot reportedNot reportedNot reported
Rituximab Plus Methotrexate149Not reportedNot reportedNot reportedNot reported
Good response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Methotrexate4Not reportedNot reportedNot reportedNot reported
Rituximab Plus Methotrexate44Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        157
      2. group Id
        OG001
        value
        105
    title
    No response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        149
    title
    Moderate response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        44
    title
    Good response
denoms
  1. counts
    1. group Id
      OG000
      value
      201
    2. group Id
      OG001
      value
      298
    units
    Participants
description
European League Against Rheumatism (EULAR) response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. At a given visit, participants with a DAS28 score of \< 3.2 are considered good responders if the change from baseline in their DAS28 score is \>1.2. Participants with a DAS28 score \>= 3.2 to 5.1 are considered moderate responders if the change from baseline in their DAS28 score is \<=1.2 to \>=0.6. Participants with DAS28 score \>5.1 are considered non-responders if the change from baseline in their DAS28 score is \<=1.2 to \>=0.6.
groups
  1. description
    Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
    id
    OG000
    title
    Placebo Plus Methotrexate
  2. description
    Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
    id
    OG001
    title
    Rituximab Plus Methotrexate
param Type
NUMBER
population Description
The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
reporting Status
POSTED
time Frame
Week 24
title
Number of Participants With Good, Moderate, or no European League Against Rheumatism Responses at Week 24
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice